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RECRUITING

NCT05503264

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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

Official title: A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Basket 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2022-09-27

Completion Date

2029-12-14

Last Updated

2026-04-03

Healthy Volunteers

Conditions

NMDAR Autoimmune Encephalitis LGI1 Autoimmune Encephalitis

Interventions

DRUG

Satralizumab

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.

OTHER

Placebo

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.

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 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 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 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 * Contraindication to all of the following rescue treatments: rituximab, intravenous immunoglobulin (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 * 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 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 * History of suicide attempt within 3 years prior to screening except if this is clearly associated with and occurs during the acute phase of LGI-1 or NMDAR encephalitis * 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

Locations (93)

University of Alabama at Birmingham

Birmingham, Alabama, United States

UC San Diego

La Jolla, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

UCSF- Multiple Sclerosis Centre

San Francisco, California, United States

University of Colorado

Aurora, Colorado, United States

Childrens National Health Center

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

Children's Healthcare of Atlanta Center for Advanced Pediatrics

Atlanta, Georgia, United States

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Brigham and Women's Hospital Department of Neurology

Boston, Massachusetts, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

NYU-Langone Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

University Hospitals of Cleveland

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Univ of Pennsylvania Med Ctr

Philadelphia, Pennsylvania, United States

University of Texas at Houston

Houston, Texas, United States

Swedish Neuroscience Institute

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Hospital Ramos Mejía

CABA, Argentina

Hospital Britanico

Ciudad Autonoma Bs As, Argentina

Sanatorio del Sur S.A.

San Miguel de Tucumán, Argentina

Kepler Universitätsklinikum GmbH - Neuromed Campus

Linz, Austria

Medizinische Universität Wien

Vienna, Austria

Hospital Geral de Fortaleza

Fortaleza, Ceará, Brazil

CEDOES - Diagnóstico e Pesquisa

Vitória, Espírito Santo, Brazil

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

Centro de Pesquisas Clinicas

São Paulo, São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Beijing Children's Hospital, Capital Medical University

Beijing, China

Beijing Tongren Hospital

Beijing, China

Beijing Tiantan Hospital,Capital Medical University

Beijing, China

The First Hospital of Jilin University

Changchun, China

The Second Xiangya Hospital of Central South University

Changsha, China

West China Hospital - Sichuan University

Chengdu, China

Fujian Medical University Union Hospital

Fuzhou, China

Guangzhou First Municipal People's Hospital

Guangzhou, China

Affiliated Hospital of Jining Medical University

Jining, China

Huashan Hospital, Fudan University

Shanghai, China

The First Hospital of Shanxi Medical University

Taiyuan, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

Odense Universitetshospital, Neurologisk Afdeling N

Odense C, Denmark

Hopital neurologique Pierre Wertheimer - CHU Lyon

Bron, France

Hopital Pitié Salpétrière - CHU

Paris, France

CHU Saint Etienne - Hôpital Nord

Saint-Etienne, France

CHRU - Hôpital Bretonneau

Tours, France

Komfo Anokye Teaching Hospital

Kumasi, Ghana

Hadassah University Hospital Ein Kerem

Jerusalem, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

A. O. U. Federico II

Naples, Campania, Italy

AOU Seconda Università degli Studi

Naples, Campania, Italy

Ospedale Pediatrico Bambino Gesù

Rome, Lazio, Italy

Irccs A.O.U.San Martino Ist

Genoa, Liguria, Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

Fondazione Istituto Neurologico Mondino IRCCS

Pavia, Lombardy, Italy

AOU Policlinico Giaccone

Palermo, Sicily, Italy

Fujita Health University Hospital

Aichi, Japan

Chiba University Hospital

Chiba, Japan

Kyushu University Hospital

Fukuoka, Japan

Fukuoka University Hospital

Fukuoka, Japan

Gifu University Hospital

Gifu, Japan

Hokkaido University Hospital

Hokkaido, Japan

Hyogo prefectural Kobe Children's Hospital

Hyogoken, Japan

Kobe University Hospital

Hyōgo, Japan

Kagoshima City Hospital

Kagoshima, Japan

St.Marianna University School of Medicine hospital

Kanagawa, Japan

Kitasato University Hospital

Kanagawa, Japan

Tokai University Hospital

Kanagawa, Japan

Tohoku University Hospital

Miyagi, Japan

The University of Osaka Hospital

Osaka, Japan

Kindai University Hospital

Osaka, Japan

Ageo Central General Hospital

Saitama, Japan

Juntendo University Hospital

Tokyo, Japan

Nihon University Itabashi Hospital

Tokyo, Japan

Erasmus MC

Rotterdam, Netherlands

Regionalny Szpital Specjalistyczny im. W. Bieganskiego

Grudzi?dz, Poland

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

Warsaw, Poland

SPSK nr 1

Zabrze, Poland

National University Hospital (NUH)

Singapore, Singapore

National Neuroscience Institute

Singapore, Singapore

Seoul National University Hospital

Seoul, South Korea

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, Spain

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

North Dist., Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (93)