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Hospital","Gifu","501-1194",{"type":65,"coordinates":661},[662,663],136.76039,35.42291,{"lat":663,"lon":662},{"facility":666,"status":253,"city":667,"state":41,"zip":668,"country":625,"countryCode":626,"cosmosGeoPoint":41,"geoPoint":41,"contacts":41},"Hokkaido University Hospital","Hokkaido","060-8648",{"facility":670,"status":58,"city":671,"state":41,"zip":672,"country":625,"countryCode":626,"cosmosGeoPoint":41,"geoPoint":41,"contacts":41},"Hyogo prefectural Kobe Children's Hospital","Hyogoken","6500047",{"facility":674,"status":58,"city":675,"state":41,"zip":676,"country":625,"countryCode":626,"cosmosGeoPoint":677,"geoPoint":681,"contacts":41},"Kobe University Hospital","Hyōgo","650-0017",{"type":65,"coordinates":678},[679,680],144.43333,43.36667,{"lat":680,"lon":679},{"facility":683,"status":58,"city":684,"state":41,"zip":685,"country":625,"countryCode":626,"cosmosGeoPoint":686,"geoPoint":690,"contacts":41},"Kagoshima City Hospital","Kagoshima","890-8760",{"type":65,"coordinates":687},[688,689],130.55,31.56667,{"lat":689,"lon":688},{"facility":692,"status":82,"city":693,"state":41,"zip":694,"country":625,"countryCode":626,"cosmosGeoPoint":695,"geoPoint":699,"contacts":41},"St.Marianna University School of Medicine hospital","Kanagawa","216-8511",{"type":65,"coordinates":696},[697,698],139.91667,37.58333,{"lat":698,"lon":697},{"facility":701,"status":253,"city":693,"state":41,"zip":702,"country":625,"countryCode":626,"cosmosGeoPoint":703,"geoPoint":705,"contacts":41},"Kitasato University Hospital","252-0375",{"type":65,"coordinates":704},[697,698],{"lat":698,"lon":697},{"facility":707,"status":58,"city":693,"state":41,"zip":708,"country":625,"countryCode":626,"cosmosGeoPoint":709,"geoPoint":711,"contacts":41},"Tokai University Hospital","259-1193",{"type":65,"coordinates":710},[697,698],{"lat":698,"lon":697},{"facility":713,"status":58,"city":714,"state":41,"zip":715,"country":625,"countryCode":626,"cosmosGeoPoint":716,"geoPoint":720,"contacts":41},"Tohoku University Hospital","Miyagi","980-8574",{"type":65,"coordinates":717},[718,719],128.18236,26.62566,{"lat":719,"lon":718},{"facility":722,"status":58,"city":723,"state":41,"zip":724,"country":625,"countryCode":626,"cosmosGeoPoint":725,"geoPoint":729,"contacts":41},"The University of Osaka Hospital","Osaka","565-0871",{"type":65,"coordinates":726},[727,728],135.50107,34.69379,{"lat":728,"lon":727},{"facility":731,"status":58,"city":723,"state":41,"zip":732,"country":625,"countryCode":626,"cosmosGeoPoint":733,"geoPoint":735,"contacts":41},"Kindai University Hospital","590-0197",{"type":65,"coordinates":734},[727,728],{"lat":728,"lon":727},{"facility":737,"status":58,"city":738,"state":41,"zip":739,"country":625,"countryCode":626,"cosmosGeoPoint":740,"geoPoint":744,"contacts":41},"Ageo Central General Hospital","Saitama","362-8588",{"type":65,"coordinates":741},[742,743],139.65657,35.90807,{"lat":743,"lon":742},{"facility":746,"status":58,"city":747,"state":41,"zip":748,"country":625,"countryCode":626,"cosmosGeoPoint":749,"geoPoint":753,"contacts":41},"Juntendo University Hospital","Tokyo","113-8431",{"type":65,"coordinates":750},[751,752],139.69171,35.6895,{"lat":752,"lon":751},{"facility":755,"status":58,"city":747,"state":41,"zip":756,"country":625,"countryCode":626,"cosmosGeoPoint":757,"geoPoint":759,"contacts":41},"Nihon University Itabashi Hospital","173-8610",{"type":65,"coordinates":758},[751,752],{"lat":752,"lon":751},{"facility":761,"status":58,"city":762,"state":41,"zip":763,"country":764,"countryCode":765,"cosmosGeoPoint":766,"geoPoint":770,"contacts":41},"Erasmus MC","Rotterdam","3015 GD","Netherlands","NL",{"type":65,"coordinates":767},[768,769],4.47917,51.9225,{"lat":769,"lon":768},{"facility":772,"status":131,"city":773,"state":41,"zip":774,"country":775,"countryCode":776,"cosmosGeoPoint":41,"geoPoint":41,"contacts":41},"Regionalny Szpital Specjalistyczny im. W. Bieganskiego","Grudzi?dz","86-300","Poland","PL",{"facility":778,"status":82,"city":779,"state":41,"zip":780,"country":775,"countryCode":776,"cosmosGeoPoint":781,"geoPoint":785,"contacts":41},"Szpital Uniwersytecki w Krakowie","Krakow","30-688",{"type":65,"coordinates":782},[783,784],19.93658,50.06143,{"lat":784,"lon":783},{"facility":787,"status":58,"city":788,"state":41,"zip":789,"country":775,"countryCode":776,"cosmosGeoPoint":790,"geoPoint":794,"contacts":41},"Instytut Psychiatrii i Neurologii II Klinika Neurologiczna","Warsaw","02-957",{"type":65,"coordinates":791},[792,793],21.01178,52.22977,{"lat":793,"lon":792},{"facility":796,"status":58,"city":797,"state":41,"zip":798,"country":775,"countryCode":776,"cosmosGeoPoint":799,"geoPoint":803,"contacts":41},"SPSK nr 1","Zabrze","41-800",{"type":65,"coordinates":800},[801,802],18.78576,50.32492,{"lat":802,"lon":801},{"facility":805,"status":58,"city":806,"state":41,"zip":807,"country":806,"countryCode":808,"cosmosGeoPoint":809,"geoPoint":813,"contacts":41},"National University Hospital (NUH)","Singapore","117599","SG",{"type":65,"coordinates":810},[811,812],103.85007,1.28967,{"lat":812,"lon":811},{"facility":815,"status":58,"city":806,"state":41,"zip":816,"country":806,"countryCode":808,"cosmosGeoPoint":817,"geoPoint":819,"contacts":41},"National Neuroscience Institute","308433",{"type":65,"coordinates":818},[811,812],{"lat":812,"lon":811},{"facility":821,"status":58,"city":822,"state":41,"zip":823,"country":824,"countryCode":41,"cosmosGeoPoint":825,"geoPoint":829,"contacts":41},"Seoul National University Hospital","Seoul","03080","South Korea",{"type":65,"coordinates":826},[827,828],126.9784,37.566,{"lat":828,"lon":827},{"facility":831,"status":58,"city":832,"state":833,"zip":834,"country":835,"countryCode":836,"cosmosGeoPoint":837,"geoPoint":841,"contacts":41},"Hospital Alvaro Cunqueiro","Vigo","Pontevedra","DUMMY_VALUE","Spain","ES",{"type":65,"coordinates":838},[839,840],-8.72264,42.23282,{"lat":840,"lon":839},{"facility":843,"status":58,"city":844,"state":41,"zip":845,"country":835,"countryCode":836,"cosmosGeoPoint":846,"geoPoint":850,"contacts":41},"Hospital General Universitario Gregorio Marañon","Madrid","28007",{"type":65,"coordinates":847},[848,849],-3.70256,40.4165,{"lat":849,"lon":848},{"facility":852,"status":58,"city":853,"state":41,"zip":854,"country":835,"countryCode":836,"cosmosGeoPoint":855,"geoPoint":859,"contacts":41},"Hospital Regional Universitario de Malaga ? Hospital General","Málaga","29010",{"type":65,"coordinates":856},[857,858],-4.42034,36.72016,{"lat":858,"lon":857},{"facility":861,"status":58,"city":862,"state":41,"zip":863,"country":864,"countryCode":865,"cosmosGeoPoint":866,"geoPoint":870,"contacts":41},"Kaohsiung Chang Gung Memorial Hospital","Kaohsiung City","00833","Taiwan","TW",{"type":65,"coordinates":867},[868,869],120.31333,22.61626,{"lat":869,"lon":868},{"facility":872,"status":131,"city":873,"state":41,"zip":874,"country":864,"countryCode":865,"cosmosGeoPoint":41,"geoPoint":41,"contacts":41},"China Medical University Hospital","North Dist.","40402",{"facility":876,"status":58,"city":877,"state":41,"zip":878,"country":864,"countryCode":865,"cosmosGeoPoint":879,"geoPoint":883,"contacts":41},"Chang Gung Memorial Hospital - Linkou","Taoyuan City","333",{"type":65,"coordinates":880},[881,882],121.29696,24.99368,{"lat":882,"lon":881},{"type":885,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[887],{"name":888,"class":6},"Chugai Pharmaceutical","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":900,"type":901},120,"ESTIMATED","INTERVENTIONAL",[904],"PHASE3","The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.",[907,908],"NMDAR Autoimmune Encephalitis","LGI1 Autoimmune Encephalitis","2026-06-04",{"date":911,"type":912},"2026-06-08","ACTUAL",{"date":914,"type":912},"2022-09-27",{"date":916,"type":901},"2028-12-14",{"name":5,"class":6},93]