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A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

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Trial Profile

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Mar 2023

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At a glance

  • Drugs Satralizumab (Primary)
  • Indications Neuromyelitis optica
  • Focus Registrational; Therapeutic Use
  • Acronyms SAkuraStar
  • Sponsors Chugai Pharmaceutical; Roche

    • Most Recent Events

    • 14 May 2022 This trial has been completed in Poland according to European Clinical Trials Database record.
    • 26 Apr 2022 Results from SAkuraSky and SAkuraStar assessing the long-term efficacy of satralizumab in patients with aquaporin-4-immunoglobulin-G-seropositive NMOSD, presented at the 74th Annual Meeting of the American Academy of Neurology 2022
    • 26 Apr 2022 Results of two studies (SAkuraSky and SAkuraStar) assessing long-term safety of satralizumab in patients (pts) with NMOSD during the double-blind periods and open-label extensions of the SAkura studies, presented at the 74th Annual Meeting of the American Academy of Neurology 2022.
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