Actively Recruiting
A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate Satralizumab for NMDAR and LGI1 Encephalitis
Led by Hoffmann-La Roche · Updated on 2026-06-08
120
Participants Needed
93
Research Sites
104 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
C
Chugai Pharmaceutical
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of satralizumab on participants aged 12 years and older with either anti-N-methyl-D-aspartic acid receptor (NMDAR) or anti-leucine-rich glioma-inactivated 1 (LGI1) encephalitis. This phase III clinical trial aims to assess the drug's effectiveness, safety, pharmacokinetics (PK), and pharmacodynamics (PD) in these autoimmune encephalitis conditions. The study includes both definite and probable cases of these diseases and compares satralizumab to a placebo to better understand its impact. Participants are divided into cohorts based on their specific diagnosis: adolescents and adults with NMDAR encephalitis and adults with LGI1 encephalitis. Satralizumab or placebo is administered subcutaneously according to body weight at scheduled visits starting at weeks 0, 2, 4, and then every four weeks. After the initial treatment phase, participants may choose to continue on the blinded study drug, start open-label satralizumab, or stop treatment while continuing follow-up assessments. Transition from the first to the second part of the study occurs either at primary analysis or week 52. Throughout the study, participants undergo regular assessments including monitoring of clinical improvements measured by the Modified Rankin Scale (mRS), seizure cessation, cognitive evaluations, and safety evaluations for adverse events. The study also tracks time to improvement without rescue therapy and changes in clinical assessment scales. Safety is monitored over several years, with participants followed up for adverse events for up to four years after week 52. Overall participation duration varies depending on individual treatment choices and study phases.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Reasonable exclusion of tumor or malignancy before baseline visit (randomization)
- Onset of autoimmune encephalitis symptoms 9 months or less before randomization
- Meet definition of "New Onset" or "Incomplete Responder" autoimmune encephalitis
- Women of childbearing potential must agree to remain abstinent or use effective contraception during treatment and for 3 months after final dose
- For participants in China enrollment phase: must be current residents of mainland China, Hong Kong, or Taiwan and of Chinese ancestry
- Age 12 years or older for NMDAR encephalitis cohort
- Diagnosis of probable or definite NMDAR encephalitis for NMDAR cohort
- Age 18 years or older for LGI1 encephalitis cohort
- Diagnosis of LGI1 encephalitis for LGI1 cohort
You will not qualify if you...
- Any untreated teratoma or thymoma at baseline visit (randomization)
- History of carcinoma or malignancy unless cured with no recurrence for 5 years before screening
- For NMDAR cohort, history of negative anti-NMDAR antibody in cerebrospinal fluid within 9 months of symptom onset
- Known positivity to intracellular antigen with high cancer association or GAD-65
- Known positivity to cell surface neuronal antibodies other than NMDAR and LGI1 without positivity to these antibodies
- Confirmed paraneoplastic encephalitis
- Confirmed central or peripheral nervous system demyelinating disease
- Alternative causes of symptoms
- History of herpes simplex virus encephalitis in previous 24 weeks
- Previous or concurrent treatment with IL-6 inhibitory therapy, alemtuzumab, total body irradiation, or bone marrow transplant
- Previous treatment with anti-CD19 antibody, complement inhibitors, neonatal Fc receptor antagonists, or anti-B-lymphocyte stimulator antibody
- Previous treatment with T-cell depleting therapies, cladribine, or mitoxantrone
- Oral cyclophosphamide treatment within 1 year before baseline
- Investigational drug treatment within 24 weeks prior to screening
- Concurrent use of more than one immunosuppressive therapy as background
- Contraindication to rescue treatments like rituximab, IVIG, high-dose corticosteroids, or IV cyclophosphamide
- Recent surgical procedures except minor surgeries within 4 weeks prior to baseline
- Planned surgical procedure during study
- Evidence of progressive multifocal leukoencephalopathy
- Serious uncontrolled diseases
- Congenital or acquired immunodeficiency including HIV
- Active or recurrent infections
- Infection requiring hospitalization or IV treatment within 4 weeks prior to baseline
- Positive hepatitis B or C test at screening
- Evidence of latent or active tuberculosis
- History of drug or alcohol abuse within 1 year prior to baseline
- History of diverticulitis or severe gastrointestinal disorders increasing risk of complications
- Live or live-attenuated vaccine within 6 weeks prior to baseline
- Blood, plasma, or platelet donation within 90 days prior to screening
- Severe allergic reaction to a biologic agent
- Suicide attempt within 3 years prior to screening except if associated with acute phase of encephalitis
- Any serious medical condition or lab abnormality precluding safe participation
- Pregnant, breastfeeding, or intending pregnancy during study or within 3 months after final dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks for Part 1; up to 4 years for Part 2
Participants receive satralizumab or placebo by subcutaneous injection at scheduled visits. In Part 1, injections occur at Weeks 0, 2, 4, and every 4 weeks thereafter. In Part 2, participants choose to continue blinded treatment, start open-label satralizumab, or stop treatment and continue follow-up.
Visits at Weeks 0, 2, 4, then every 4 weeks up to Week 52; continued visits during Part 2 depending on participant choice
Duration - Up to 4 years after treatment
Participants who stop treatment or continue in Part 2 are followed for safety and efficacy assessments for up to 4 years.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 93 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
UC San Diego
La Jolla, California, United States, 92037
Actively Recruiting
3
Hoag Memorial Hospital
Newport Beach, California, United States, 92658
Completed
4
UCSF- Multiple Sclerosis Centre
San Francisco, California, United States, 94158
Actively Recruiting
5
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Childrens National Health Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
7
Children's Healthcare of Atlanta Center for Advanced Pediatrics
Atlanta, Georgia, United States, 30329
Actively Recruiting
8
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
Withdrawn
9
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
10
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Actively Recruiting
11
Brigham and Women's Hospital Department of Neurology
Boston, Massachusetts, United States, 02115
Actively Recruiting
12
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
13
NYU-Langone Medical Center
New York, New York, United States, 10016
Actively Recruiting
14
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
15
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
16
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44915
Actively Recruiting
17
Univ of Pennsylvania Med Ctr
Philadelphia, Pennsylvania, United States, 19104
Withdrawn
18
University of Texas at Houston
Houston, Texas, United States, 77030
Actively Recruiting
19
Swedish Neuroscience Institute
Seattle, Washington, United States, 98122
Withdrawn
20
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
21
Hospital Ramos Mejía
CABA, Argentina, C1221ADC
Active, Not Recruiting
22
Hospital Britanico
Ciudad Autonoma Bs As, Argentina, C1280AEB
Actively Recruiting
23
Sanatorio del Sur S.A.
San Miguel de Tucumán, Argentina, T4000IDK
Actively Recruiting
24
Kepler Universitätsklinikum GmbH - Neuromed Campus
Linz, Austria, 4020
Withdrawn
25
Medizinische Universität Wien
Vienna, Austria, 1090
Withdrawn
26
Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil, 60175-295
Actively Recruiting
27
CEDOES - Diagnóstico e Pesquisa
Vitória, Espírito Santo, Brazil, 29055-450
Actively Recruiting
28
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil, 81210-310
Actively Recruiting
29
Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil, 01228-200
Actively Recruiting
30
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil, 05652-000
Actively Recruiting
31
Beijing Children's Hospital, Capital Medical University
Beijing, China, 100045
Actively Recruiting
32
Beijing Tongren Hospital
Beijing, China, 100730
Actively Recruiting
33
Beijing Tiantan Hospital,Capital Medical University
Beijing, China
Actively Recruiting
34
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
35
The Second Xiangya Hospital of Central South University
Changsha, China, 410011
Actively Recruiting
36
West China Hospital - Sichuan University
Chengdu, China, 610047
Actively Recruiting
37
Fujian Medical University Union Hospital
Fuzhou, China, 350001
Actively Recruiting
38
Guangzhou First Municipal People's Hospital
Guangzhou, China, 510180
Withdrawn
39
Affiliated Hospital of Jining Medical University
Jining, China, 272029
Actively Recruiting
40
Huashan Hospital, Fudan University
Shanghai, China, 200040
Actively Recruiting
41
The First Hospital of Shanxi Medical University
Taiyuan, China, 030001
Actively Recruiting
42
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China, 325035
Completed
43
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430030
Withdrawn
44
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
Withdrawn
45
Fakultni nemocnice v Motole
Prague, Czechia, 150 06
Actively Recruiting
46
Odense Universitetshospital, Neurologisk Afdeling N
Odense C, Denmark, 5000
Actively Recruiting
47
Hopital neurologique Pierre Wertheimer - CHU Lyon
Bron, France, 69677
Completed
48
Hopital Pitié Salpétrière - CHU
Paris, France, 75651
Actively Recruiting
49
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, France, 42055
Withdrawn
50
CHRU - Hôpital Bretonneau
Tours, France, 37000
Actively Recruiting
51
Komfo Anokye Teaching Hospital
Kumasi, Ghana
Actively Recruiting
52
Hadassah University Hospital Ein Kerem
Jerusalem, Israel, 9112001
Actively Recruiting
53
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
54
A. O. U. Federico II
Naples, Campania, Italy, 80131
Actively Recruiting
55
AOU Seconda Università degli Studi
Naples, Campania, Italy, 80138
Actively Recruiting
56
Ospedale Pediatrico Bambino Gesù
Rome, Lazio, Italy, 00165
Withdrawn
57
Irccs A.O.U.San Martino Ist
Genoa, Liguria, Italy, 16132
Actively Recruiting
58
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
59
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Lombardy, Italy, 20133
Actively Recruiting
60
Fondazione Istituto Neurologico Mondino IRCCS
Pavia, Lombardy, Italy, 27100
Actively Recruiting
61
AOU Policlinico Giaccone
Palermo, Sicily, Italy, 90129
Actively Recruiting
62
Fujita Health University Hospital
Aichi, Japan, 470-1192
Actively Recruiting
63
Chiba University Hospital
Chiba, Japan, 260-8677
Active, Not Recruiting
64
Kyushu University Hospital
Fukuoka, Japan, 812-8582
Completed
65
Fukuoka University Hospital
Fukuoka, Japan, 814-0180
Actively Recruiting
66
Gifu University Hospital
Gifu, Japan, 501-1194
Actively Recruiting
67
Hokkaido University Hospital
Hokkaido, Japan, 060-8648
Active, Not Recruiting
68
Hyogo prefectural Kobe Children's Hospital
Hyogoken, Japan, 6500047
Actively Recruiting
69
Kobe University Hospital
Hyōgo, Japan, 650-0017
Actively Recruiting
70
Kagoshima City Hospital
Kagoshima, Japan, 890-8760
Actively Recruiting
71
St.Marianna University School of Medicine hospital
Kanagawa, Japan, 216-8511
Completed
72
Kitasato University Hospital
Kanagawa, Japan, 252-0375
Active, Not Recruiting
73
Tokai University Hospital
Kanagawa, Japan, 259-1193
Actively Recruiting
74
Tohoku University Hospital
Miyagi, Japan, 980-8574
Actively Recruiting
75
The University of Osaka Hospital
Osaka, Japan, 565-0871
Actively Recruiting
76
Kindai University Hospital
Osaka, Japan, 590-0197
Actively Recruiting
77
Ageo Central General Hospital
Saitama, Japan, 362-8588
Actively Recruiting
78
Juntendo University Hospital
Tokyo, Japan, 113-8431
Actively Recruiting
79
Nihon University Itabashi Hospital
Tokyo, Japan, 173-8610
Actively Recruiting
80
Erasmus MC
Rotterdam, Netherlands, 3015 GD
Actively Recruiting
81
Regionalny Szpital Specjalistyczny im. W. Bieganskiego
Grudzi?dz, Poland, 86-300
Withdrawn
82
Szpital Uniwersytecki w Krakowie
Krakow, Poland, 30-688
Completed
83
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw, Poland, 02-957
Actively Recruiting
84
SPSK nr 1
Zabrze, Poland, 41-800
Actively Recruiting
85
National University Hospital (NUH)
Singapore, Singapore, 117599
Actively Recruiting
86
National Neuroscience Institute
Singapore, Singapore, 308433
Actively Recruiting
87
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
88
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain, DUMMY_VALUE
Actively Recruiting
89
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
90
Hospital Regional Universitario de Malaga ? Hospital General
Málaga, Spain, 29010
Actively Recruiting
91
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 00833
Actively Recruiting
92
China Medical University Hospital
North Dist., Taiwan, 40402
Withdrawn
93
Chang Gung Memorial Hospital - Linkou
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
R
Reference Study ID Number: WN43174, https://forpatients.roche.com/
G
Global Medical Information:
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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