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

NCT05503264 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: WN431742021-002395-392023-504226-18-00
• Study Type: interventional
• Target: 152
• Locations: 18 countries
• Sites: 93

Brief Summary

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

Conditions

LGI1 Autoimmune Encephalitis; NMDAR Autoimmune Encephalitis

Outcome Measures

Primary Outcomes (3)

• Part 1: Proportion of Participants in NMDAR AIE Cohort With Modified Rankin Scale (mRS) Score Improvement ≥ 1 From Baseline and no Use of Rescue Therapy at Week 24

  Baseline up to Week 24

• Part 1: Proportion of Participants in LGI1 AIE Cohort With mRS Score Improvement ≥ 1 From Baseline and no Use of Rescue Therapy at Week 52

  Baseline up to Week 52

• Part 2: Percentage of Participants With Adverse Events (AEs)

  From Week 52 up to 2 years

Secondary Outcomes (11)

• Part 1 (NMDAR AIE Cohort and LGI1 Cohort): Time to mRS Score Improvement ≥ 1 From Baseline Without Use of Rescue Therapy

  Baseline up to Week 52

• Part 1 (NMDAR AIE Cohort and LGI1 AIE Cohort): Time to Rescue Therapy

  Baseline up to Week 52

• Part 1 (NMDAR AIE Cohort and LGI1 AIE Cohort): Proportion of Participants With Sustained Seizure Cessation at Week 24

  Baseline up to Week 24

• Part 1 (NMDAR AIE Cohort): Change in Clinical Assessment Scale in Autoimmune Encephalitis (CASE) Score From Baseline at Week 24

  Baseline up to Week 24

• Part 1 (LGI1 AIE Cohort): Change in CASE Score From Baseline at Week 52

  Baseline up to Week 52

Study Arms (4)

NMDAR Autoimmune Encephalitis (AIE) Cohort

EXPERIMENTAL

Adults and adolescents with definite or probable NMDAR encephalitis

Drug: Satralizumab

LGI1 AIE Cohort

EXPERIMENTAL

Adults with LGI1 encephalitis

Drug: Satralizumab

NMDAR AIE Placebo Cohort

PLACEBO COMPARATOR

Adults and adolescents with definite or probable NMDAR encephalitis

Other: Placebo

LGI1 AIE Placebo Cohort

PLACEBO COMPARATOR

Adults with LGI1 encephalitis

Other: Placebo

Interventions

Satralizumab DRUG

In Part 1, study drug will be administered after all other study-related procedures have been performed at a site visit at Weeks 0, 2, 4, and every 4 weeks (Q4W) thereafter. Participants will receive satralizumab according to body weight. Study drug will be administered by subcutaneous (SC) injection in the abdominal or femoral region after all other study-related procedures have been performed at a site visit. In Part 2, participants will be asked to choose from one of the following options: Option 1: continue on randomized, double-blind study drug; Option 2: start open-label satralizumab based on body weight; Option 3: stop study treatment and continue follow-up assessments.

LGI1 AIE Cohort; NMDAR Autoimmune Encephalitis (AIE) Cohort

Placebo OTHER

Satralizumab placebo prefilled syringe (PFS) is identical in composition to satralizumab PFS, but does not contain the satralizumab active ingredient and will be identical in appearance and packaging to satralizumab. A PFS (assembled with an needle safety device \[NSD\] and extended finger flange) filled with 0.5 milliliters (mL) of solution, corresponding to 60 milligrams (mg) satralizumab, may be used in Part 2 once it becomes available at the study site.

LGI1 AIE Placebo Cohort; NMDAR AIE Placebo Cohort

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 China's sites: participants who are current residents of mainland China, Hong Kong, or Taiwan, and of 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

You may not qualify if:

• 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 participants 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 glutamate decarboxylase 65 (GAD-65)
• Historically known positivity to any cell surface neuronal antibodies other than NMDAR 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 marrow transplantation
• Any previous treatment with anti-cluster of differentiation 19 antibody (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 immunosuppressive therapy (IST) as background therapy

Sponsors & Collaborators

• Hoffmann-La Roche: lead
• Chugai Pharmaceutical: collaborator

Study Sites (93)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

UC San Diego

La Jolla, California, 92037, United States

RECRUITING

Hoag Memorial Hospital

Newport Beach, California, 92658, United States

RECRUITING

UCSF- Multiple Sclerosis Centre

San Francisco, California, 94158, United States

RECRUITING

University of Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Childrens National Health Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Children's Healthcare of Atlanta Center for Advanced Pediatrics

Atlanta, Georgia, 30329, United States

RECRUITING

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

WITHDRAWN

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

RECRUITING

Brigham and Women's Hospital Department of Neurology

Boston, Massachusetts, 02115, United States

RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

NYU-Langone Medical Center

New York, New York, 10016, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44915, United States

RECRUITING

Univ of Pennsylvania Med Ctr

Philadelphia, Pennsylvania, 19104, United States

WITHDRAWN

University of Texas at Houston

Houston, Texas, 77030, United States

RECRUITING

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

WITHDRAWN

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Hospital Ramos Mejía

CABA, C1221ADC, Argentina

ACTIVE NOT RECRUITING

Hospital Britanico

Ciudad Autonoma Bs As, C1280AEB, Argentina

RECRUITING

Sanatorio del Sur S.A.

San Miguel de Tucumán, T4000IDK, Argentina

RECRUITING

Kepler Universitätsklinikum GmbH - Neuromed Campus

Linz, 4020, Austria

WITHDRAWN

Medizinische Universität Wien

Vienna, 1090, Austria

WITHDRAWN

Hospital Geral de Fortaleza

Fortaleza, Ceará, 60175-295, Brazil

RECRUITING

CEDOES - Diagnóstico e Pesquisa

Vitória, Espírito Santo, 29055-450, Brazil

RECRUITING

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

RECRUITING

Centro de Pesquisas Clinicas

São Paulo, São Paulo, 01228-200, Brazil

RECRUITING

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652-000, Brazil

RECRUITING

Beijing Children's Hospital, Capital Medical University

Beijing, 100045, China

RECRUITING

Beijing Tongren Hospital

Beijing, 100730, China

RECRUITING

Beijing Tiantan Hospital,Capital Medical University

Beijing, China

RECRUITING

The First Hospital of Jilin University

Changchun, 130021, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, 410011, China

RECRUITING

West China Hospital - Sichuan University

Chengdu, 610047, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, 350001, China

RECRUITING

Guangzhou First Municipal People's Hospital

Guangzhou, 510180, China

RECRUITING

Affiliated Hospital of Jining Medical University

Jining, 272029, China

RECRUITING

Huashan Hospital, Fudan University

Shanghai, 200040, China

RECRUITING

The First Hospital of Shanxi Medical University

Taiyuan, 030001, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, 325035, China

COMPLETED

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030, China

RECRUITING

Fakultni nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

WITHDRAWN

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

RECRUITING

Odense Universitetshospital, Neurologisk Afdeling N

Odense C, 5000, Denmark

RECRUITING

Hopital neurologique Pierre Wertheimer - CHU Lyon

Bron, 69677, France

COMPLETED

Hopital Pitié Salpétrière - CHU

Paris, 75651, France

RECRUITING

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, 42055, France

WITHDRAWN

CHRU - Hôpital Bretonneau

Tours, 37000, France

RECRUITING

Komfo Anokye Teaching Hospital

Kumasi, Ghana

RECRUITING

Hadassah University Hospital Ein Kerem

Jerusalem, 9112001, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

A. O. U. Federico II

Naples, Campania, 80131, Italy

RECRUITING

AOU Seconda Università degli Studi

Naples, Campania, 80138, Italy

RECRUITING

Ospedale Pediatrico Bambino Gesù

Rome, Lazio, 00165, Italy

WITHDRAWN

Irccs A.O.U.San Martino Ist

Genoa, Liguria, 16132, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, 20133, Italy

RECRUITING

Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Lombardy, 27100, Italy

RECRUITING

AOU Policlinico Giaccone

Palermo, Sicily, 90129, Italy

RECRUITING

Fujita Health University Hospital

Aichi, 470-1192, Japan

RECRUITING

Chiba University Hospital

Chiba, 260-8677, Japan

ACTIVE NOT RECRUITING

Kyushu University Hospital

Fukuoka, 812-8582, Japan

COMPLETED

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

RECRUITING

Gifu University Hospital

Gifu, 501-1194, Japan

RECRUITING

Hokkaido University Hospital

Hokkaido, 060-8648, Japan

ACTIVE NOT RECRUITING

Hyogo prefectural Kobe Children's Hospital

Hyogoken, 6500047, Japan

RECRUITING

Kobe University Hospital

Hyōgo, 650-0017, Japan

RECRUITING

Kagoshima City Hospital

Kagoshima, 890-8760, Japan

RECRUITING

St.Marianna University School of Medicine hospital

Kanagawa, 216-8511, Japan

COMPLETED

Kitasato University Hospital

Kanagawa, 252-0375, Japan

ACTIVE NOT RECRUITING

Tokai University Hospital

Kanagawa, 259-1193, Japan

RECRUITING

Tohoku University Hospital

Miyagi, 980-8574, Japan

RECRUITING

The University of Osaka Hospital

Osaka, 565-0871, Japan

RECRUITING

Kindai University Hospital

Osaka, 590-0197, Japan

RECRUITING

Ageo Central General Hospital

Saitama, 362-8588, Japan

RECRUITING

Juntendo University Hospital

Tokyo, 113-8431, Japan

RECRUITING

Nihon University Itabashi Hospital

Tokyo, 173-8610, Japan

RECRUITING

Erasmus MC

Rotterdam, 3015 GD, Netherlands

RECRUITING

Regionalny Szpital Specjalistyczny im. W. Bieganskiego

Grudzi?dz, 86-300, Poland

WITHDRAWN

Szpital Uniwersytecki w Krakowie

Krakow, 30-688, Poland

COMPLETED

Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

Warsaw, 02-957, Poland

RECRUITING

SPSK nr 1

Zabrze, 41-800, Poland

RECRUITING

National University Hospital (NUH)

Singapore, 117599, Singapore

RECRUITING

National Neuroscience Institute

Singapore, 308433, Singapore

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, DUMMY_VALUE, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

RECRUITING

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, 29010, Spain

RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 00833, Taiwan

RECRUITING

China Medical University Hospital

North Dist., 40402, Taiwan

WITHDRAWN

Chang Gung Memorial Hospital - Linkou

Taoyuan City, 333, Taiwan

RECRUITING

MeSH Terms

Interventions

satralizumab

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WN43174, https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S.); global-roche-genentech-trials@gene.com

Global Medical Information:

CONTACT

global.medical_information@roche.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 16, 2022
• Study Start: September 27, 2022
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): December 14, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

TW (3); KR (1); US (20); BR (5); IL (2); PL (4); GH (1); CZ (2); AR (3); JP (18); AU (2); CN (13); SG (2); IT (8); NL (1); ES (3); DK (1); FR (4)