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A 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

Recruiting
12 years of age
Both
Phase 3

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Overview

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.

Eligibility

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

Study details

NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis

NCT05503264

Hoffmann-La Roche

17 June 2024

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