Long-term, open-label, safety study of inebilizumab in Neuromyelitis optica spectrum disorder (NMOSD)N-MOmentum LT
Study Details
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
Protocol Summary
Change from baseline in serum Ig levels (total Ig, IgG, IgM, IgA, IgE) over time
Timeframe: Up to 42 months
Change from baseline in peripheral CD20+ B-cell counts over time
Timeframe: Up to 42 months
Change from baseline in hematology over time
Timeframe: Up to 42 months
Change from baseline in clinical chemistry over time
Timeframe: Up to 42 months
Incidence of serious infections
Timeframe: Up to 42 months
Incidence of viral reactivation
Timeframe: Up to 42 months
Incidence of progressive multifocal leukoencephalopathy (PML)
Timeframe: Up to 42 months
Incidence of other opportunistic infections
Timeframe: Up to 42 months
Incidence of malignancies
Timeframe: Up to 42 months
Incidence of infusion reactions
Timeframe: Up to 42 months
Number of protocol-defined NMOSD attacks
Timeframe: Up to 42 months
Percentage of protocol-defined NMOSD attacks
Timeframe: Up to 42 months
Incidence of Anti-drug antibody (ADA) directed against Inebilizumab status and titers
Timeframe: Up to 42 months