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

  • LGI1 Autoimmune Encephalitis
  • NMDAR Autoimmune Encephalitis
Trial Status:

Not yet recruiting

This trial runs in
Countries
  • Czechia
Trial Identifier:

NCT05503264 WN43174

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial 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.

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT05503264 , WN43174 Trial Identifier
      Satralizumab, Placebo Treatments
      NMDAR Autoimmune Encephalitis, LGI1 Autoimmune Encephalitis Condition
      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

      Eligibility Criteria

      All Gender
      ≥12 Years Age
      No Healthy Volunteers
      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

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