The primary objective of this study is to confirm the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ravulizumab in the treatment of Chinese adults with anti-aquaporin-4 (AQP4) antibody (Ab) + neuromyelitis optica spectrum disorder (NMOSD).
Diagnosis: NMOSD per 2015 international consensus criteria, and anti AQP4 antibody positive at Screening.
Disease activity: ≥1 attack/relapse in the past 12 months.
Disability: EDSS ≤7.
Background therapy: If on IST and/or oral corticosteroids, participant should be on a stable maintenance regimen prior to Screening and plan to remain stable during the study unless relapse occurs. (Detailed agent specific duration/dose rules to be confirmed at screening.)
None
Single group
Ravulizumab
DrugParticipants will receive ravulizumab via intravenous (IV) infusion.
Adjudicated On-Trial Annualized Relapse Rate (ARR)
Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) Score
Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) Score
Change From Baseline in European Quality of Life Health 5-item Questionnaire (EQ-5D) Index Score
Change From Baseline in EQ-5D Visual Analog Scale (VAS) Score
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