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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 73 Locations for this study
Birmingham Alabama, 35294, United States
Newport Beach California, 92658, United States
San Francisco California, 94158, United States
Aurora Colorado, 80045, United States
Iowa City Iowa, 52242, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21205, United States
Boston Massachusetts, 02115, United States
Rochester Minnesota, 55905, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44915, United States
Seattle Washington, 98122, United States
Milwaukee Wisconsin, 53226, United States
Caba , C1221, Argentina
Ciudad Autonoma Bs As , C1280, Argentina
San Miguel de Tucuman , T4000, Argentina
Linz , 4020, Austria
Wien , 1090, Austria
Vitoria ES, 29055, Brazil
Curitiba PR, 81210, Brazil
Sao Paulo SP, 01228, Brazil
Beijing City , 10004, China
Beijing City , 10005, China
Beijing , 10073, China
Changchun City , 13002, China
Changsha , 41001, China
Chengdu City , 61004, China
Fuzhou City , 35000, China
Guangzhou , 51018, China
Jining , 27202, China
Shanghai City , 20004, China
Taiyuan , 03000, China
Wenzhou City , 32503, China
Wuhan City , 43003, China
Hradec Kralove , 500 0, Czechia
Praha 5 , 150 0, Czechia
Odense C , 5000, Denmark
Bron , 69677, France
Tours , 37000, France
Kumasi , , Ghana
Napoli Campania, 80131, Italy
Napoli Campania, 80138, Italy
Roma Lazio, 00165, Italy
Genova Liguria, 16132, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Pavia Lombardia, 27100, Italy
Palermo Sicilia, 90129, Italy
Aichi , 470-1, Japan
Chiba , 260-8, Japan
Fukuoka , 812-8, Japan
Fukuoka , 814-0, Japan
Gifu , 501-1, Japan
Hokkaido , 060-8, Japan
Hyogoken , 65000, Japan
Hyogo , 650-0, Japan
Kanagawa , 216-8, Japan
Kanagawa , 252-0, Japan
Kanagawa , 259-1, Japan
Miyagi , 980-8, Japan
Osaka-sayama , 589-8, Japan
Osaka , 565-0, Japan
Saitama , 362-8, Japan
Tokyo , 113-8, Japan
Tokyo , 173-8, Japan
Seoul , 03080, Korea, Republic of
Rotterdam , 3015 , Netherlands
Grudzi?dz , 86-30, Poland
Kraków , 31-50, Poland
Warszawa , 02-95, Poland
Zabrze , 41-80, Poland
Kaohsiung City , 00833, Taiwan
North Dist. , 40402, Taiwan
Taoyuan , 333, Taiwan
How clear is this clinincal trial information?