Long-term, Open-label, Safety Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD)
Status:
Recruiting
Trial end date:
2028-06-30
Target enrollment:
Participant gender:
Summary
The purpose of this study is to understand the effects of long-term treatment with
inebilizumab on circulating levels of immunoglobulins, B-cell counts, and other safety
measures, and to further monitor repletion of immunoglobins and B-cell counts in participants
with NMOSD who discontinue treatment. The objectives include:
1. To establish the nadir in circulating immunoglobulins (Ig) during chronic treatment with
inebilizumab and ascertain the time needed to ensure restoration of pre-treatment
baseline serum levels of IgG and IgM after discontinuation of treatment
2. To characterize B-cell counts throughout treatment with inebilizumab and after
discontinuation until repletion of Immunoglobulin (Ig levels)
3. To assess long-term safety of inebilizumab
4. To assess other long-term effects of inebilizumab