The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.
Reasonable exclusion of tumor or malignancy before baseline visit (randomization)
Onset of AIE symptoms ≤ 9 months before randomization
Meet the definition of "New Onset" or "Incomplete Responder" AIE
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab or placebo
Any untreated teratoma or thymoma at baseline visit (randomization)
History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening
For participants with NMDAR AIE, history of negative anti-NMDAR antibody in cerebrospinal fluid (CSF) using a cell-based assay within 9 months of symptom onset
Historically known positivity to an intracellular antigen with high cancer association or glutamate decarboxylase 65 (GAD-65)
Hoffmann-La Roche
Lead sponsor
Chugai Pharmaceutical
Collaborator