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

Last updated: April 3, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Memory Loss

Treatment

Placebo

Satralizumab

Clinical Study ID

NCT05503264
WN43174
2021-002395-39
2023-504226-18-00
  • Ages > 12
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy, safety, PK, and PD of satralizumab in participants with NMDAR and LGI1 encephalitis.

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

Total Participants: 152
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 27, 2022
Estimated Completion Date:
December 07, 2028

Connect with a study center

  • Hospital Ramos Mejía

    Caba, C1221ADC
    Argentina

    Site Not Available

  • Hospital Britanico

    Ciudad Autonoma Bs As, C1280AEB
    Argentina

    Active - Recruiting

  • Sanatorio del Sur S.A.

    San Miguel de Tucuman, T4000IDK
    Argentina

    Active - Recruiting

  • Kepler Universitätsklinikum GmbH - Neuromed Campus

    Linz, 4020
    Austria

    Active - Recruiting

  • Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie

    Linz, 4020
    Austria

    Active - Recruiting

  • Medizinische Universität Wien

    Wien, 1090
    Austria

    Site Not Available

  • Medizinische Universität Wien; Univ.Klinik fuer Neurologie

    Wien, 1090
    Austria

    Active - Recruiting

  • CEDOES - Diagnóstico e Pesquisa

    Vitoria, Espírito Santo 29055-450
    Brazil

    Active - Recruiting

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná 81210-310
    Brazil

    Active - Recruiting

  • Centro de Pesquisas Clinicas; CPCLIN

    Sao Paulo, SP 01228-200
    Brazil

    Site Not Available

  • Centro de Pesquisas Clinicas

    Sao Paulo, São Paulo 01228-200
    Brazil

    Site Not Available

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100050
    China

    Active - Recruiting

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Beijing Tongren Hospital

    Beijing, 100730
    China

    Site Not Available

  • Beijing Children's Hospital, Capital Medical University

    Beijing City, 100045
    China

    Active - Recruiting

  • Beijing Tiantan Hospital,Capital Medical University

    Beijing City, 100050
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun City, 130021
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, 410011
    China

    Active - Recruiting

  • West China Hospital - Sichuan University

    Chengdu City, 610047
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou City, 350001
    China

    Active - Recruiting

  • Guangzhou First Municipal People's Hospital

    Guangzhou, 510180
    China

    Active - Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining, 272029
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai City, 200040
    China

    Active - Recruiting

  • The First Hospital of Shanxi Medical University

    Taiyuan, 030001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou City, 325035
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan City, 430030
    China

    Active - Recruiting

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, 500 05
    Czechia

    Active - Recruiting

  • VFN Praha Poliklinika Rs Centrum - Budova A

    Prague, 12808
    Czechia

    Site Not Available

  • Fakultni nemocnice v Motole

    Praha 5, 150 06
    Czechia

    Active - Recruiting

  • Fakultni nemocnice v Motole; Neurologicka klinika 2. LF UK a FN Motol

    Praha 5, 150 06
    Czechia

    Active - Recruiting

  • Odense Universitetshospital, Neurologisk Afdeling N

    Odense C, 5000
    Denmark

    Active - Recruiting

  • Hopital neurologique Pierre Wertheimer - CHU Lyon

    Bron, 69677
    France

    Site Not Available

  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

    Bron, 69677
    France

    Site Not Available

  • Hopital Pitié Salpétrière - CHU

    Paris, 75651
    France

    Active - Recruiting

  • Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

    Paris, 75651
    France

    Active - Recruiting

  • CHU Saint Etienne - Hôpital Nord

    Saint Etienne, 42055
    France

    Active - Recruiting

  • CHRU - Hôpital Bretonneau

    Tours, 37000
    France

    Active - Recruiting

  • CHRU - Hôpital Bretonneau; Neurologie

    Tours, 37000
    France

    Active - Recruiting

  • Komfo Anokye Teaching Hospital

    Kumasi,
    Ghana

    Active - Recruiting

  • Komfo Anokye Teaching Hospital; Department of Medicine

    Kumasi,
    Ghana

    Active - Recruiting

  • A. O. U. Federico II

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

    Napoli, Campania 80131
    Italy

    Active - Recruiting

  • AOU Seconda Università degli Studi

    Napoli, Campania 80138
    Italy

    Active - Recruiting

  • AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica

    Napoli, Campania 80138
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesù; Divisione di Neurologia

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • Irccs A.O.U.San Martino Ist

    Genova, Liguria 16132
    Italy

    Active - Recruiting

  • Irccs A.O.U.San Martino Ist; Dinogmi

    Genova, Liguria 16132
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milano, Lombardia 20133
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

    Milano, Lombardia 20132
    Italy

    Active - Recruiting

  • Fondazione Istituto Neurologico Mondino IRCCS

    Pavia, Lombardia 27100
    Italy

    Active - Recruiting

  • AOU Policlinico Giaccone

    Palermo, Sicilia 90129
    Italy

    Active - Recruiting

  • AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

    Palermo, Sicilia 90129
    Italy

    Active - Recruiting

  • Fujita Health University Hospital

    Aichi, 470-1192
    Japan

    Active - Recruiting

  • Chiba University Hospital

    Chiba, 260-8677
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka, 814-0180
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • Gifu University Hospital

    Gifu, 501-1194
    Japan

    Site Not Available

  • Hokkaido University Hospital

    Hokkaido, 060-8648
    Japan

    Site Not Available

  • Kobe University Hospital

    Hyogo, 650-0017
    Japan

    Active - Recruiting

  • Hyogo prefectural Kobe Children's Hospital

    Hyogoken, 6500047
    Japan

    Active - Recruiting

  • Kagoshima City Hospital

    Kagoshima, 890-8760
    Japan

    Active - Recruiting

  • Kitasato University Hospital

    Kanagawa, 252-0375
    Japan

    Site Not Available

  • St.Marianna University School of Medicine hospital

    Kanagawa, 216-8511
    Japan

    Site Not Available

  • St.Marianna University School of Medicine hospital; Medical Oncology

    Kanagawa, 216-8511
    Japan

    Site Not Available

  • Tokai University Hospital

    Kanagawa, 259-1193
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Miyagi, 980-8574
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Osaka, 565-0871
    Japan

    Active - Recruiting

  • Kindai University Hospital

    Osaka-sayama, 589-8511
    Japan

    Active - Recruiting

  • Kindai University Hospital ; Faculty of Medicine

    Osaka-sayama, 589-8511
    Japan

    Active - Recruiting

  • Kinki University Hospital, Faculty of Medicine

    Osaka-sayama, 589-8511
    Japan

    Active - Recruiting

  • Ageo Central General Hospital

    Saitama, 362-8588
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Tokyo, 113-8431
    Japan

    Active - Recruiting

  • Nihon University Itabashi Hospital

    Tokyo, 173-8610
    Japan

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego

    Grudzi?dz, 86-300
    Poland

    Site Not Available

  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Neurologiczny

    Grudzi?dz, 86-300
    Poland

    Site Not Available

  • Szpital Uniwersytecki w Krakowie

    Kraków, 30-688
    Poland

    Completed

  • Szpital Uniwersytecki w Krakowie; Oddzia? kliniczny Neurologii

    Kraków, 31-503
    Poland

    Site Not Available

  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

    Warszawa, 02-957
    Poland

    Active - Recruiting

  • SPSK nr 1

    Zabrze, 41-800
    Poland

    Active - Recruiting

  • SPSK nr 1; Klinika Neurologii

    Zabrze, 41-800
    Poland

    Active - Recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 00833
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    North Dist., 40402
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • UC San Diego

    La Jolla, California 92037
    United States

    Active - Recruiting

  • UC San Diego; ACTRI

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Hoag Memorial Hospital

    Newport Beach, California 92658
    United States

    Active - Recruiting

  • UCSF- Multiple Sclerosis Centre

    San Francisco, California 94158
    United States

    Active - Recruiting

  • UCSF- Multiple Sclerosis Centre; Department of Neurology

    San Francisco, California 94158
    United States

    Active - Recruiting

  • University of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado; Anschutz Medical Campus Department of Neurology

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Iowa Hospitals & Clinics; Department of Neurology

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • Johns Hopkins Hospital; Neurology

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • University of Maryland Medical Center

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • University of Maryland Medical Center; Department of Neurology

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Brigham and Women's Hospital Department of Neurology

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • NYU-Langone Medical Center

    New York, New York 10016
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44915
    United States

    Active - Recruiting

  • University Hospitals of Cleveland

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Univ of Pennsylvania Med Ctr

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Texas at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Swedish Neuroscience Institute

    Seattle, Washington 98122
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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