a clinical research study of inebilizumab in neuromyelitis optica spectrum disorders

Conditions: Neuromyelitis Optica Spectrum Disorders

Summary: to assess the efficacy and safety of inebilizumab in chinese adult patients with neuromyelitis optica spectrum disorders.


Eligibility criteria:
inclusion criteria: * patients who have comprehensive understanding of the study content, process and possible adverse reactions, and sign the informed consent forms voluntarily * men and women 18 years or older * patients with nmosd diagnosed according to the definition in the guidelines for the diagnosis and treatment of neuromyelitis optica spectrum disorders in china * patients with positive serum anti-aqp4-igg results at screening * a documented history of one or more nmosd acute relapses that required rescue therapy within the last year, or 2 or more nmosd acute relapses that required rescue therapy within 2 years prior to screening * patients with edss score of ≤ 7.5 points * patients who and whose sexual partner agree to take highly effective method of contraception from screening 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.