Neuromyelitis Optica Spectrum Disorder Inebilizumab Study in Children and Adolescents

You likely can't join if

• 1. Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the IP or interpretation of subject safety or study results 2. 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 Day 1 3. Females who are breastfeeding, pregnant, or who intend to become pregnant at any time from screening until 6 months after the final dose of IP 4. Known history of allergy or reaction to any component of the IP formulation or history of anaphylaxis following any biologic therapy 5. Evidence of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to Day 1 6. Major surgery within 8 weeks prior to screening 7. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to screening 8. Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality 9. B-cell counts < one-half of the lower limit of normal (LLN) for age according to the central laboratory 10. Receipt of the following at any time prior to Day 1: a. Alemtuzumab b. Total lymphoid irradiation c. Bone marrow transplant d. T-cell vaccination therapy 11. Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior to screening unless B-cell counts have returned to ≥ one-half the LLN. 12. Receipt of intravenous immunoglobulin (IVIG) within one month prior to Day 1 13. Receipt of any of the following within 2 months prior to Day 1: a. Cyclosporine b. Methotrexate c. Mitoxantrone d. Cyclophosphamide e. Tocilizumab f. Satralizumab g. Eculizumab 14. Receipt of natalizumab (Tysabri®) within 6 months prior to Day 1 15. Severe drug allergic history or anaphylaxis to 2 or more food products or medicine 16. Diagnosed with a concurrent autoimmune disease that is uncontrolled (unless approved by the medical monitor) 17. Receipt of any of the following: a. Any live or attenuated vaccine within 4 weeks prior to Day 1 b. Bacillus Calmette-Guérin vaccine within one year of screening c. Blood transfusion within 4 weeks prior to screening or during screening 18. Clinically significant serious active or chronic viral, bacterial, or fungal infection that requires treatment with anti-infectives, within 2 months prior to Day 1 19. Known history of congenital or acquired immunodeficiency that predisposes the subject to infection 20. Positive test for chronic hepatitis B infection at screening 21. Positive test for hepatitis C virus antibody 22. Negative test for varicella zoster virus (VZV)-IgG 23. History of cancer, apart from squamous cell or basal cell carcinoma of the skin treated with documented success of curative therapy > 3 months prior to Day 1 24. History of active or latent tuberculosis 25. For subjects who may undergo MRI scans: Unable to undergo an MRI scan (eg, hypersensitivity to Gd containing MRI contrast agents, implanted pacemakers, defibrillators, or other metallic objects on or inside the body that limit performing MRI scans), or unable to tolerate or comply with the MRI procedure.
• (Polish Continuation) 25. For subjects who may undergo MRI scans: Unable to undergo an MRI scan (eg, hypersensitivity to Gd containing MRI contrast agents, implanted pacemakers, defibrillators, or other metallic objects on or inside the body that limit performing MRI scans), or unable to tolerate or comply with the MRI procedure.