[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lgi1-autoimmune-encephalitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lgi1-autoimmune-encephalitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100477922","phase-3-a-study-to-evaluate-the-efficacy-safety-pharmacokinetics-pk-and-pharmacodynamics-pd-of-satralizumab-in-participants-with-anti-n-methyl-d-aspartic-acid-receptor-nmdar-or-anti-leucine-rich-glioma-inactivated-1-lgi1-encephalitis-100477922",false,"NCT05503264","A Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Satralizumab in Participants With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis","A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Basket Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Anti-N-methyl-D-aspartic Acid Receptor (NMDAR) or Anti-leucine-rich Glioma-inactivated 1 (LGI1) Encephalitis","Cielo","Inclusion Criteria:\n\n* Reasonable exclusion of tumor or malignancy before baseline visit (randomization)\n* Onset of AIE symptoms ≤ 9 months before randomization\n* Meet the definition of \"New Onset\" or \"Incomplete Responder\" AIE\n* 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\n* For participants enrolled in the extended China enrollment phase at China's sites: participants who are current residents of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry\n\nNMDAR AIE Cohort:\n\n* Age ≥ 12 years\n* Diagnosis of probable or definite NMDAR encephalitis\n\nLGI1 AIE Cohort\n\n* Age ≥ 18 years\n* Diagnosis of LGI1 encephalitis\n\nExclusion Criteria:\n\n* Any untreated teratoma or thymoma at baseline visit (randomization)\n* History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening\n* 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\n* Historically known positivity to an intracellular antigen with high cancer association or glutamate decarboxylase 65 (GAD-65)\n* Historically known positivity to any cell surface neuronal antibodies other than NMDAR and LGI1, in the absence of NMDAR and LGI1 antibody positivity\n* Confirmed paraneoplastic encephalitis\n* Confirmed central nervous system (CNS) or peripheral nervous system (PNS) demyelinating disease\n* Alternative causes of associated symptoms\n* History of herpes simplex virus encephalitis in the previous 24 weeks\n* Any previous\u002Fconcurrent treatment with interleukin-6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrow transplantation\n* Any previous treatment with anti-cluster of differentiation 19 antibody (CD19 antibody), complement inhibitors, neonatal Fc receptor antagonists, anti-B-lymphocyte stimulator monoclonal antibody\n* Any previous treatment with T-cell depleting therapies, cladribine, or mitoxantrone\n* Treatment with oral cyclophosphamide within 1 year prior to baseline\n* Treatment with any investigational drug (including bortezomib) within 24 weeks prior to screening\n* Concurrent use of more than one immunosuppressive therapy (IST) as background therapy\n* Contraindication to all of the following rescue treatments: rituximab, intravenous immunoglobulin (IVIG), high-dose corticosteroids, or intravenous (IV) cyclophosphamide\n* Any surgical procedure, except laparoscopic surgery or minor surgeries within 4 weeks prior to baseline, excluding surgery for thymoma or teratoma removal\n* Planned surgical procedure during the study\n* Evidence of progressive multifocal leukoencephalopathy\n* Evidence of serious uncontrolled concomitant diseases\n* Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection\n* Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection\n* Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit\n* Positive hepatitis B (HBV) and hepatitis C (HCV) test at screening\n* Evidence of latent or active tuberculosis (TB)\n* History of drug or alcohol abuse within 1 year prior to baseline\n* History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator's opinion, may lead to increased risk of complications such as GI perforation\n* Receipt of live or live-attenuated vaccine within 6 weeks prior to baseline visit\n* History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening\n* History of severe allergic reaction to a biologic agent\n* History of suicide attempt within 3 years prior to screening except if this is clearly associated with and occurs during the acute phase of LGI-1 or NMDAR encephalitis\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes safe participation in and completion of the study\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug","ALL","12 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.",[27,28],"NMDAR Autoimmune Encephalitis","LGI1 Autoimmune Encephalitis","RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":33},"2022-09-27",{"date":37,"type":21},"2028-12-14",{"name":39,"class":40},"Hoffmann-La Roche","INDUSTRY",93]