An Open-label, Single-arm, Multi-Center, Interventional Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Chinese Adult Participants With Anti-Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorders (NMOSD)
The primary objective of this study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Eculizumab in Chinese Adults with Neuromyelitis Optica Spectrum Disorders (NMOSD).
• Participants with diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria
• Anti-AQP4 antibody positive
• At least 1 attack or relapse in the last 12 months prior to the Screening Period
• EDSS score ≤ 7
• If a participant enters the study receiving IST(s) for relapse prevention, the participant must be on a stable maintenance dose of IST(s) as follows, prior to screening and must remain on that dose for the duration of the study, unless the participant experiences a relapse
• Female participants of childbearing potential must have a negative pregnancy test (serum HCG at screening
• Male participants are eligible to participate if they agree to the following during the study intervention Treatment Period and for at least 5 months after the last dose of study intervention:
‣ Refrain from donating fresh unwashed semen. PLUS, either,
⁃ Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
⁃ Must agree to use barrier as detailed below:
∙ Agree to use a male condom when having sexual intercourse with a WOCBP who is not currently pregnant.