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  • 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 (ExTINGUISH) Jacksonville, Fla.

    The purpose of this study is to define the effectiveness and safety of Inebilizumab in reducing the level of disability in patients with NMDAR encephalitis as measured by modified Rankin score (mRS).

    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. 
  • Collection of biospecimens for lab based analysis in healthy controls Rochester, Minn.

    The purpose of this study is to collect healthy patient samples and give us a normal patient levels of antibodies, cytokines and other meaningful biomarkers that we are analyzing in patients with neurological conditions. It will help define better diagnostic criteria and hopefully lead to biomarkers that will help assign treatments which lead to better outcomes for patients with neurological disease. 

    The study consists of 1 visit, which will take about 3 hours. At this visit we will:

    • Perform a urine pregnancy test for women of childbearing potential

    • Draw a blood sample 

    • Perform a lumbar puncture and collect cerebrospinal fluid

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  • 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 (ExTINGUISH) Rochester, Minn., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to define the effectiveness and safety of Inebilizumab in reducing the level of disability in patients with NMDAR encephalitis as measured by modified Rankin score (mRS).

    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. 
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