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A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Trial Profile

A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Apr 2023

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At a glance

  • Drugs Satralizumab (Primary)
  • Indications Neuromyelitis optica
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Therapeutic Use
  • Acronyms SAkuraSky
  • Sponsors Roche
  • Most Recent Events

    • 24 Aug 2022 Planned number of patients changed from 70 to 85.
    • 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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