Multiple Sclerosis Clinical Trial

A 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

Summary

The purpose of this study is to assess the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab in participants with anti-N-methyl-D-aspartic acid receptor (NMDAR) and anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Reasonable exclusion of tumor or malignancy before baseline visit (randomization)
Onset of autoimmune encephalitis (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 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
For participants enrolled in the extended China enrollment phase at National Medical Products Administration (NMPA)-recognized sites: participants who are current residents of mainland China, Hong Kong, or Taiwan, and of Chinese ancestry

N-methyl-D-aspartic acid receptor (NMDAR) AIE Cohort

Age >=12 years
Diagnosis of probable or definite NMDAR encephalitis

Leucine-rich glioma-inactivated 1 (LGI1) AIE Cohort

Age >=18 years
Diagnosis of LGI1 encephalitis

Exclusion Criteria:

Any untreated teratoma or thymoma at baseline visit (randomization)
History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for >=5 years before screening
For patients with NMDAR AIE, history of negative anti-NMDAR antibody in cerebrospinal fluid (CSF) using a cell-based assay within 9 months of symptom onset
Historically known positivity to an intracellular antigen with high cancer association or GAD-65
Historically known positivity to any cell surface neuronal antibodies other than NMDAR and LGI1
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 IL-6 inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrow transplantation
Any previous treatment with anti-CD19 antibody, 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 prior to screening
Concurrent use of more than one IST as background therapy
Contraindication to all of the following rescue treatments: rituximab, IVIG, high-dose corticosteroids, or intravenous (IV) cyclophosphamide
Any surgical procedure, except laparoscopic surgery or minor surgeries within 4 weeks 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 that may preclude patient participation
Congenital or acquired immunodeficiency, including HIV infection
Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection
Infection requiring hospitalization or treatment with IV anti-infective agents within 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 as GI 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 donation within 90 days prior to screening
History of severe allergic reaction to a biologic agent
Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening
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
Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug
Laboratory abnormalities at Screening

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

152

Study ID:

NCT05503264

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 73 Locations for this study

See Locations Near You

University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Hoag Memorial Hospital
Newport Beach California, 92658, United States
UCSF- Multiple Sclerosis Centre; Department of Neurology
San Francisco California, 94158, United States
University of Colorado; Anschutz Medical Campus Department of Neurology
Aurora Colorado, 80045, United States
University of Iowa Hospitals & Clinics; Department of Neurology
Iowa City Iowa, 52242, United States
University of Maryland Medical Center; Department of Neurology
Baltimore Maryland, 21201, United States
Johns Hopkins Hospital; Neurology
Baltimore Maryland, 21205, United States
Brigham and Women's Hospital Department of Neurology
Boston Massachusetts, 02115, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
University Hospitals of Cleveland
Cleveland Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44915, United States
Swedish Neuroscience Institute
Seattle Washington, 98122, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Hospital Ramos Mejía
Caba , C1221, Argentina
Hospital Britanico
Ciudad Autonoma Bs As , C1280, Argentina
Sanatorio del Sur S.A.
San Miguel de Tucuman , T4000, Argentina
Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie
Linz , 4020, Austria
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
Wien , 1090, Austria
CEDOES - Diagnóstico e Pesquisa
Vitoria ES, 29055, Brazil
Instituto de Neurologia de Curitiba
Curitiba PR, 81210, Brazil
Centro de Pesquisas Clinicas; CPCLIN
Sao Paulo SP, 01228, Brazil
Beijing Children's Hospital, Capital Medical University
Beijing City , 10004, China
Beijing Tiantan Hospital,Capital Medical University
Beijing City , 10005, China
Beijing Tongren Hospital
Beijing , 10073, China
The First Hospital of Jilin University
Changchun City , 13002, China
The Second Xiangya Hospital of Central South University
Changsha , 41001, China
West China Hospital - Sichuan University
Chengdu City , 61004, China
Fujian Medical University Union Hospital
Fuzhou City , 35000, China
Guangzhou First Municipal People's Hospital
Guangzhou , 51018, China
Affiliated Hospital of Jining Medical University
Jining , 27202, China
Huashan Hospital, Fudan University
Shanghai City , 20004, China
The First Hospital of Shanxi Medical University
Taiyuan , 03000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou City , 32503, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City , 43003, China
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Fakultni nemocnice v Motole; Neurologicka klinika 2. LF UK a FN Motol
Praha 5 , 150 0, Czechia
Odense Universitetshospital, Neurologisk Afdeling N
Odense C , 5000, Denmark
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron , 69677, France
CHRU - Hôpital Bretonneau; Neurologie
Tours , 37000, France
Komfo Anokye Teaching Hospital; Department of Medicine
Kumasi , , Ghana
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
Napoli Campania, 80131, Italy
AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica
Napoli Campania, 80138, Italy
Ospedale Pediatrico Bambino Gesù; Divisione di Neurologia
Roma Lazio, 00165, Italy
Irccs A.O.U.San Martino Ist; Dinogmi
Genova Liguria, 16132, Italy
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milano Lombardia, 20132, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano Lombardia, 20133, Italy
Fondazione Istituto Neurologico Mondino IRCCS
Pavia Lombardia, 27100, Italy
AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla
Palermo Sicilia, 90129, Italy
Fujita Health University Hospital
Aichi , 470-1, Japan
Chiba University Hospital
Chiba , 260-8, Japan
Kyushu University Hospital
Fukuoka , 812-8, Japan
Fukuoka University Hospital
Fukuoka , 814-0, Japan
Gifu University Hospital
Gifu , 501-1, Japan
Hokkaido University Hospital
Hokkaido , 060-8, Japan
Hyogo prefectural Kobe Children's Hospital
Hyogoken , 65000, Japan
Kobe University Hospital
Hyogo , 650-0, Japan
St.Marianna University School of Medicine hospital; Medical Oncology
Kanagawa , 216-8, Japan
Kitasato University Hospital
Kanagawa , 252-0, Japan
Tokai University Hospital
Kanagawa , 259-1, Japan
Tohoku University Hospital
Miyagi , 980-8, Japan
Kinki University Hospital, Faculty of Medicine
Osaka-sayama , 589-8, Japan
Osaka University Hospital
Osaka , 565-0, Japan
Ageo Central General Hospital
Saitama , 362-8, Japan
Juntendo University Hospital
Tokyo , 113-8, Japan
Nihon University Itabashi Hospital
Tokyo , 173-8, Japan
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Erasmus MC
Rotterdam , 3015 , Netherlands
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Neurologiczny
Grudzi?dz , 86-30, Poland
Szpital Uniwersytecki w Krakowie; Oddzia? kliniczny Neurologii
Kraków , 31-50, Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warszawa , 02-95, Poland
SPSK nr 1; Klinika Neurologii
Zabrze , 41-80, Poland
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City , 00833, Taiwan
China Medical University Hospital
North Dist. , 40402, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan , 333, Taiwan

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

152

Study ID:

NCT05503264

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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