A Study To Evaluate The Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Anti-N-Methyl-D-Asparti Acid Receptor (NMDAR) Or Anti-Leucine-Rich Glioma-Inactivated 1 (LGI1) Encephalitis

• Status: Not yet recruiting
• Trial end date: 2027-12-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Collaborator: Chugai Pharmaceutical Co.

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