Phase
Condition
Memory Loss
Treatment
Placebo
Satralizumab
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 fromheterosexual intercourse) or use adequate contraception during the treatment periodand for at least 3 months after the final dose of satralizumab or placebo
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, andof Chinese ancestry
NMDAR AIE Cohort:
Age ≥ 12 years
Diagnosis of probable or definite NMDAR encephalitis
LGI1 AIE Cohort
Age ≥ 18 years
Diagnosis of LGI1 encephalitis
Exclusion
Exclusion Criteria:
Any untreated teratoma or thymoma at baseline visit (randomization)
History of carcinoma or malignancy, unless deemed cured by adequate treatment withno evidence of recurrence for ≥ 5 years before screening
For participants with NMDAR AIE, history of negative anti-NMDAR antibody incerebrospinal fluid (CSF) using a cell-based assay within 9 months of symptom onset
Historically known positivity to an intracellular antigen with high cancerassociation or glutamate decarboxylase 65 (GAD-65)
Historically known positivity to any cell surface neuronal antibodies other thanNMDAR and LGI1, in the absence of NMDAR and LGI1 antibody positivity
Confirmed paraneoplastic encephalitis
Confirmed central or peripheral nervous system demyelinating disease
Alternative causes of associated symptoms
History of herpes simplex virus encephalitis in the previous 24 weeks
Any previous/concurrent treatment with interleukin-6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrowtransplantation
Any previous treatment with anti-cluster of differentiation 19 antibody (CD19antibody), complement inhibitors, neonatal Fc receptor antagonists,anti-B-lymphocyte stimulator monoclonal antibody
Any previous treatment with T-cell depleting therapies, cladribine, or mitoxantrone
Treatment with oral cyclophosphamide within 1 year prior to baseline
Treatment with any investigational drug (including bortezomib) within 24 weeks priorto screening
Concurrent use of more than one immunosuppressive therapy (IST) as backgroundtherapy
Contraindication to all of the following rescue treatments: rituximab, intravenousimmunoglobulin (IVIG), high-dose corticosteroids, or intravenous (IV)cyclophosphamide
Any surgical procedure, except laparoscopic surgery or minor surgeries within 4weeks prior to baseline, excluding surgery for thymoma or teratoma removal
Planned surgical procedure during the study
Evidence of progressive multifocal leukoencephalopathy
Evidence of serious uncontrolled concomitant diseases
Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection
Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection,or other infection
Infection requiring hospitalization or treatment with IV anti-infective agentswithin 4 weeks prior to baseline visit
Positive hepatitis B (HBV) and hepatitis C (HCV) test at screening
Evidence of latent or active tuberculosis (TB)
History of drug or alcohol abuse within 1 year prior to baseline
History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that,in the investigator's opinion, may lead to increased risk of complications such asGI perforation
Receipt of live or live-attenuated vaccine within 6 weeks prior to baseline visit
History of blood donation (1 unit or more), plasma donation or platelet donationwithin 90 days prior to screening
History of severe allergic reaction to a biologic agent
History of suicide attempt within 3 years prior to screening except if this isclearly associated with and occurs during the acute phase of LGI-1 or NMDARencephalitis
Any serious medical condition or abnormality in clinical laboratory tests that, inthe investigator's judgment, precludes safe participation in and completion of thestudy
Pregnant or breastfeeding, or intending to become pregnant during the study orwithin 3 months after the final dose of study drug
Study Design
Connect with a study center
Hospital Ramos Mejía
Caba, C1221ADC
ArgentinaSite Not Available
Hospital Britanico
Ciudad Autonoma Bs As, C1280AEB
ArgentinaActive - Recruiting
Sanatorio del Sur S.A.
San Miguel de Tucuman, T4000IDK
ArgentinaActive - Recruiting
Kepler Universitätsklinikum GmbH - Neuromed Campus
Linz, 4020
AustriaActive - Recruiting
Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie
Linz, 4020
AustriaActive - Recruiting
Medizinische Universität Wien
Wien, 1090
AustriaSite Not Available
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
Wien, 1090
AustriaActive - Recruiting
CEDOES - Diagnóstico e Pesquisa
Vitoria, Espírito Santo 29055-450
BrazilActive - Recruiting
Instituto de Neurologia de Curitiba
Curitiba, Paraná 81210-310
BrazilActive - Recruiting
Centro de Pesquisas Clinicas; CPCLIN
Sao Paulo, SP 01228-200
BrazilSite Not Available
Centro de Pesquisas Clinicas
Sao Paulo, São Paulo 01228-200
BrazilSite Not Available
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050
ChinaActive - Recruiting
Beijing Tiantan Hospital,Capital Medical University
Beijing,
ChinaActive - Recruiting
Beijing Tongren Hospital
Beijing, 100730
ChinaSite Not Available
Beijing Children's Hospital, Capital Medical University
Beijing City, 100045
ChinaActive - Recruiting
Beijing Tiantan Hospital,Capital Medical University
Beijing City, 100050
ChinaActive - Recruiting
The First Hospital of Jilin University
Changchun City, 130021
ChinaActive - Recruiting
The Second Xiangya Hospital of Central South University
Changsha, 410011
ChinaActive - Recruiting
West China Hospital - Sichuan University
Chengdu City, 610047
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou City, 350001
ChinaActive - Recruiting
Guangzhou First Municipal People's Hospital
Guangzhou, 510180
ChinaActive - Recruiting
Affiliated Hospital of Jining Medical University
Jining, 272029
ChinaActive - Recruiting
Huashan Hospital, Fudan University
Shanghai City, 200040
ChinaActive - Recruiting
The First Hospital of Shanxi Medical University
Taiyuan, 030001
ChinaActive - Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou City, 325035
ChinaSite Not Available
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City, 430030
ChinaActive - Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Kralove, 500 05
CzechiaActive - Recruiting
VFN Praha Poliklinika Rs Centrum - Budova A
Prague, 12808
CzechiaSite Not Available
Fakultni nemocnice v Motole
Praha 5, 150 06
CzechiaActive - Recruiting
Fakultni nemocnice v Motole; Neurologicka klinika 2. LF UK a FN Motol
Praha 5, 150 06
CzechiaActive - Recruiting
Odense Universitetshospital, Neurologisk Afdeling N
Odense C, 5000
DenmarkActive - Recruiting
Hopital neurologique Pierre Wertheimer - CHU Lyon
Bron, 69677
FranceSite Not Available
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, 69677
FranceSite Not Available
Hopital Pitié Salpétrière - CHU
Paris, 75651
FranceActive - Recruiting
Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin
Paris, 75651
FranceActive - Recruiting
CHU Saint Etienne - Hôpital Nord
Saint Etienne, 42055
FranceActive - Recruiting
CHRU - Hôpital Bretonneau
Tours, 37000
FranceActive - Recruiting
CHRU - Hôpital Bretonneau; Neurologie
Tours, 37000
FranceActive - Recruiting
Komfo Anokye Teaching Hospital
Kumasi,
GhanaActive - Recruiting
Komfo Anokye Teaching Hospital; Department of Medicine
Kumasi,
GhanaActive - Recruiting
A. O. U. Federico II
Napoli, Campania 80131
ItalyActive - Recruiting
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
Napoli, Campania 80131
ItalyActive - Recruiting
AOU Seconda Università degli Studi
Napoli, Campania 80138
ItalyActive - Recruiting
AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica
Napoli, Campania 80138
ItalyActive - Recruiting
Ospedale Pediatrico Bambino Gesù
Roma, Lazio 00165
ItalyActive - Recruiting
Ospedale Pediatrico Bambino Gesù; Divisione di Neurologia
Roma, Lazio 00165
ItalyActive - Recruiting
Irccs A.O.U.San Martino Ist
Genova, Liguria 16132
ItalyActive - Recruiting
Irccs A.O.U.San Martino Ist; Dinogmi
Genova, Liguria 16132
ItalyActive - Recruiting
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano, Lombardia 20133
ItalyActive - Recruiting
IRCCS Ospedale San Raffaele
Milano, Lombardia 20132
ItalyActive - Recruiting
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milano, Lombardia 20132
ItalyActive - Recruiting
Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardia 27100
ItalyActive - Recruiting
AOU Policlinico Giaccone
Palermo, Sicilia 90129
ItalyActive - Recruiting
AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla
Palermo, Sicilia 90129
ItalyActive - Recruiting
Fujita Health University Hospital
Aichi, 470-1192
JapanActive - Recruiting
Chiba University Hospital
Chiba, 260-8677
JapanSite Not Available
Fukuoka University Hospital
Fukuoka, 814-0180
JapanActive - Recruiting
Kyushu University Hospital
Fukuoka, 812-8582
JapanSite Not Available
Gifu University Hospital
Gifu, 501-1194
JapanSite Not Available
Hokkaido University Hospital
Hokkaido, 060-8648
JapanSite Not Available
Kobe University Hospital
Hyogo, 650-0017
JapanActive - Recruiting
Hyogo prefectural Kobe Children's Hospital
Hyogoken, 6500047
JapanActive - Recruiting
Kagoshima City Hospital
Kagoshima, 890-8760
JapanActive - Recruiting
Kitasato University Hospital
Kanagawa, 252-0375
JapanSite Not Available
St.Marianna University School of Medicine hospital
Kanagawa, 216-8511
JapanSite Not Available
St.Marianna University School of Medicine hospital; Medical Oncology
Kanagawa, 216-8511
JapanSite Not Available
Tokai University Hospital
Kanagawa, 259-1193
JapanActive - Recruiting
Tohoku University Hospital
Miyagi, 980-8574
JapanActive - Recruiting
Osaka University Hospital
Osaka, 565-0871
JapanActive - Recruiting
Kindai University Hospital
Osaka-sayama, 589-8511
JapanActive - Recruiting
Kindai University Hospital ; Faculty of Medicine
Osaka-sayama, 589-8511
JapanActive - Recruiting
Kinki University Hospital, Faculty of Medicine
Osaka-sayama, 589-8511
JapanActive - Recruiting
Ageo Central General Hospital
Saitama, 362-8588
JapanActive - Recruiting
Juntendo University Hospital
Tokyo, 113-8431
JapanActive - Recruiting
Nihon University Itabashi Hospital
Tokyo, 173-8610
JapanSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofActive - Recruiting
Erasmus MC
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
Regionalny Szpital Specjalistyczny im. W. Bieganskiego
Grudzi?dz, 86-300
PolandSite Not Available
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Neurologiczny
Grudzi?dz, 86-300
PolandSite Not Available
Szpital Uniwersytecki w Krakowie
Kraków, 30-688
PolandCompleted
Szpital Uniwersytecki w Krakowie; Oddzia? kliniczny Neurologii
Kraków, 31-503
PolandSite Not Available
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warszawa, 02-957
PolandActive - Recruiting
SPSK nr 1
Zabrze, 41-800
PolandActive - Recruiting
SPSK nr 1; Klinika Neurologii
Zabrze, 41-800
PolandActive - Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 00833
TaiwanActive - Recruiting
China Medical University Hospital
North Dist., 40402
TaiwanActive - Recruiting
Chang Gung Memorial Hospital - Linkou
Taoyuan, 333
TaiwanSite Not Available
Chang Gung Memorial Hospital - Linkou
Taoyuan City, 333
TaiwanActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesActive - Recruiting
UC San Diego
La Jolla, California 92037
United StatesActive - Recruiting
UC San Diego; ACTRI
La Jolla, California 92037
United StatesActive - Recruiting
Hoag Memorial Hospital
Newport Beach, California 92658
United StatesActive - Recruiting
UCSF- Multiple Sclerosis Centre
San Francisco, California 94158
United StatesActive - Recruiting
UCSF- Multiple Sclerosis Centre; Department of Neurology
San Francisco, California 94158
United StatesActive - Recruiting
University of Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado; Anschutz Medical Campus Department of Neurology
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United StatesActive - Recruiting
University of Iowa Hospitals & Clinics; Department of Neurology
Iowa City, Iowa 52242
United StatesActive - Recruiting
Johns Hopkins Hospital
Baltimore, Maryland 21205
United StatesActive - Recruiting
Johns Hopkins Hospital; Neurology
Baltimore, Maryland 21205
United StatesActive - Recruiting
University of Maryland Medical Center
Baltimore, Maryland 21201
United StatesActive - Recruiting
University of Maryland Medical Center; Department of Neurology
Baltimore, Maryland 21201
United StatesActive - Recruiting
Brigham and Women's Hospital Department of Neurology
Boston, Massachusetts 02115
United StatesActive - Recruiting
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
NYU-Langone Medical Center
New York, New York 10016
United StatesActive - Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio 44915
United StatesActive - Recruiting
University Hospitals of Cleveland
Cleveland, Ohio 44106
United StatesActive - Recruiting
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
University of Texas at Houston
Houston, Texas 77030
United StatesActive - Recruiting
Swedish Neuroscience Institute
Seattle, Washington 98122
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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