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A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Trial Profile

A Double-masked, Placebo-controlled Study With Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects With Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 23 Jan 2024

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At a glance

  • Drugs Inebilizumab (Primary)
  • Indications Neuromyelitis optica
  • Focus Registrational; Therapeutic Use
  • Acronyms N-MOmentum
  • Sponsors AstraZeneca; MedImmune
  • Most Recent Events

    • 16 Jan 2024 According to a Horizon Therapeutics plc media release, company announced that on December 15, 2023, Health Canada approved UPLIZNA (inebilizumab for injection) as a monotherapy for the treatment of adult patients with NMOSD who are AQP4-IgG+. Health Canada approval is based on results from the N-MOmentum pivotal trial.
    • 13 Oct 2023 Results assessing long-term comparative efficacy of INEB over N-MOmentum OLE vs azathioprine and other immunosuppressive therapies (AZA/IST) and vs PBO in participants with NMOSD, presented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis.
    • 13 Oct 2023 Results assessing the relationship between cytokine levels and disease activity in NMOSD participants from N-MOmentum, presented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis.
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