A phase-2B, double-blind, randomized controlled trial to evaluate the activity and safety of inebilizumab in anti-NMDA receptor encephalitis and assess markers of disease.
There are currently no medicinal products approved for the treatment of anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis, a rare disease.
NMDAR encephalitis is a life-threatening, antibody-mediated autoimmune disorder of the central nervous system. Standard of care includes high-dose corticosteroids AND either intravenous immunoglobulin (IVIg) OR plasmapheresis. However, as many as 47% of patients may fail to respond to initial treatment at 4 weeks; thus, there is a high unmet medical need for more effective therapies. The pathogenesis of NMDAR encephalitis suggests that B cell depletion may be an effective avenue for therapeutic intervention. The anti-CD19 B cell-depleting activity of inebilizumab suggests that it may provide benefit as treatment for NMDAR encephalitis.
This study aims to define the efficacy and safety of inebilizumab in reducing the level of disability in patients with NMDAR encephalitis as measured by modified Rankin score (mRS).