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

Prior treatment

• A relapse occurring less than 30 days before signing the informed consent form or at screening (patients may be re-screened)
• 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

Other illness

• 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

Other

• Intrathecal oligoclonal or monoclonal IgG production (in patients who are anti-AQP4 seronegative)

• NMOSD diagnosed based on the 2015 NMOSD International Consensus Diagnostic Criteria
• Documented evidence of at least 1 relapse within 12 months before signing the informed consent form, or 2 relapses within 24 months before signing the informed consent form
• A total EDSS score of ≤ 7
• Presence of IgG antibodies to the Varicella Zoster virus at screening
• A CD19+ cell proportion of ≥ 1 % of the total lymphocyte count in patients exposed to other anti-B-cell therapies more than 6 months before signing the informed consent form