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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis

In brief

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

Key facts

Study ID

NCT05503264

Run by

Hoffmann-La Roche

People needed

122

Starts

2022-09-27

Expected to finish

2028-12-14

Last updated by the study team

2026-07-10

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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 nervous system (CNS) or peripheral nervous system (PNS) 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)

Where it is running

• 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 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
• University of Texas at Houston — Houston, Texas, 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
• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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