Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE)

Exclusion Criteria

• •A relapse occurring less than 30 days before signing the informed consent form or at screening (patients may be re-screened)
• •Intrathecal oligoclonal or monoclonal IgG production (in patients who are anti-AQP4 seronegative)
• •Other nervous system disorders (including multiple sclerosis) that can mask or affect the assessment of NMOSD symptoms
• •History of other autoimmune diseases requiring immunosuppressive therapy
• •Prior exposure to: alemtuzumab, total lymphatic irradiation, bone marrow transplantation; anti-B-cell therapy drugs, abatacept, satralizumab within 6 months prior to signing the informed consent form; mitoxantrone, cyclophosphamide, methotrexate, cyclosporine A, tacrolimus, eculizumab, tocilizumab, natalizumab, interferon beta, glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate within 3 months before signing the informed consent form; immunoglobulin products within 30 days before signing the informed consent form; transfusion of blood or blood components within 30 days before signing the informed consent form; systemic corticosteroids at the time of signing the informed consent form