[Translation] A study evaluating the efficacy of satrolizumab in patients with anti-N-methyl-D-aspartate receptor (NMDAR) or anti-leucine-rich glioma-inactivating protein 1 (LGI1) encephalitis Phase III, randomized, double-blind, placebo-controlled, multicenter basket study of , safety, pharmacokinetic and pharmacodynamic characteristics
本研究将在以下各队列中评估萨特利珠单抗对比安慰剂的有效性、安全性、药代动力学和药效学特征:
● NMDAR自身免疫性脑炎(AIE)队列: 已确诊或疑似NMDAR脑炎的成人或青少年患者
● LGI1 AIE队列: LGI1脑炎成人患者
此外,本研究将在可选扩展期期间评估萨特利珠单抗的长期安全性和有效性。
[Translation] The study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of sattilizumab compared with placebo in the following cohorts:
● NMDAR autoimmune encephalitis (AIE) cohort: adult or adolescent patients with confirmed or suspected NMDAR encephalitis
● LGI1 AIE cohort: adults with LGI1 encephalitis
In addition, the study will assess the long-term safety and efficacy of satrolizumab during an optional extension period.