A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders

Exclusion Criteria

• •Patients who have received any of the following treatments at any time prior to randomization:
• •1. Monoclonal antibodies against CD52: such as alemtuzumab, etc.
• •2. Total lymphoid irradiation
• •3. Bone marrow transplant
• •4. T-cell vaccination therapy
• •Receipt of rituximab or other B-cell depleting agents (e.g., Belimumab, Telitacicept) within 6 months prior to screening, unless the patient has B-cell counts above the LLN according to the central laboratory;
• •Receipt of rituximab or other B-cell depleting agents (e.g., Belimumab, Telitacicept) within 6 months prior to screening, unless the patient has B-cell counts above the LLN according to the central laboratory;
• •Patients who have received intravenous injection of immunoglobulin (IVIG) within 1 month prior to randomization;
• •Patients who have received immunosuppressant therapy (e.g., cyclophosphamide, methotrexate, mitoxantrone, ciclosporin A, etc.) and biologics (satralizumab, natalizumab, tocilizumab, eculizumab, etc.) within 3 months or 5 half-lives of such drugs (whichever is longer) before randomization;
• •Any concomitant disease other than NMOSD that required treatment with oral or IV steroids at doses \> 20 mg/day for \> 21 days within the 6 months prior to screening;
• •Concurrent/previous enrollment in another clinical study involving an investigational treatment within 4 weeks or 5 published half-lives of the investigational treatment, whichever is the longer, prior to enrollment;
• •Severe drug allergic history or anaphylaxis to two or more food products or medicine (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid); Known history of allergy or reaction to any component of the investigational product formulation or history of anaphylaxis following any biologic therapy;
• •Patients with evidence of alcohol, drug, or chemical abuse, or with history of such abuse within 1 year prior to randomization;
• •Female patients who are lactating or pregnant, or plan to become pregnant at any time from signing the informed consent through the study plus 6 months following last dose of investigational product;
• •Patients with clinically significant serious active or chronic viral infection, or bacterial infection within 60 days prior to randomization, which requires treatment with anti-infective agents or hospitalization, or might pose an additional risk to the patient in the opinion of the investigator;
• •Patients with known history or underlying disease of primary immunodeficiency (congenital or acquired), such as human immunodeficiency virus (HIV) infection or splenectomy, which predisposes the patient to infection;
• •Confirmed positive serology results of hepatitis B/C at screening
• •Patients with history of malignancy, except squamous or basal cell carcinoma of skin that has been successfully treated with documented success of curative therapy \> 3 months prior to randomization;
• •Any other conditions that, in the opinion of the investigator, are not suitable for participating in the clinical study.