Study of Inebilizumab in Pediatric Subjects With Neuromyelitis Optica Spectrum Disorder

Open to people ages 2-17

• Male or female subjects age 2 to < 18 years at the time of screening.
• Positive serum anti-AQP4-IgG result at screening and diagnosed with NMOSD according to the criteria of Wingerchuk et al, 2015.
• Documented history of one or more NMOSD acute relapses within the last year, or 2 or more NMOSD acute relapses within 2 years prior to screening.

• Any condition that, in the opinion of the Investigator, would interfere with the evaluation or administration of the Investigational Product or interpretation of subject safety or study results
• 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
• Evidence of significant hepatic, renal, or metabolic dysfunction or significant hematological abnormality (one repeat test may be conducted to confirm results within the same screening period):
• B-cell counts < one-half of the lower limit of normal (LLN) for age according to the central laboratory
• Receipt of the following at any time prior to Day 1:
  1. Alemtuzumab
  2. Total lymphoid irradiation
  3. Bone marrow transplant
  4. T-cell vaccination therapy
• 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
• Receipt of intravenous immunoglobulin (IVIG) within one month prior to Day 1
• Receipt of any of the following within 2 months prior to Day 1:
  1. Cyclosporine
  2. Methotrexate
  3. Mitoxantrone
  4. Cyclophosphamide
  5. Tocilizumab
  6. Satralizumab
  7. Eculizumab
• Receipt of natalizumab (Tysabri®) within 6 months prior to Day 1
• Severe drug allergic history or anaphylaxis to 2 or more food products or medicine (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamine, and methylprednisolone or equivalent glucocorticoid)
• Diagnosed with a concurrent autoimmune disease that is uncontrolled (unless approved by the medical monitor)
• Recent receipt of live/attenuated vaccine or blood transfusion