Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Epilepsy
• Age: Between 12 Year(s) - 99 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Capable of providing signed informed consent.
  2. 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.
  3. Onset of AIE symptoms 9 months before randomization.
  4. Meet the definition of "New Onset" or "Incomplete Responder" AIE.

  
  

You may not be eligible for this study if the following are true:

• 1. Any untreated teratoma or thymoma at baseline visit (randomization).
  2. History of carcinoma or malignancy, unless deemed cured by adequate treatment with no evidence of recurrence for 5 or more years before screening (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured).
  3. Alternative causes of associated symptoms, including CNS infections, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatologic disorders, Reyes syndrome, or inborn errors of metabolism.
  4. History of herpes simplex virus encephalitis in the previous 24 weeks.
  5. Any previous/concurrent treatment with IL-6 inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation, or bone marrow transplantation.
  6. Any previous treatment with anti-CD19 antibody, complement inhibitors, neonatal Fc receptor antagonists, anti-B-lymphocyte stimulator monoclonal antibody (e.g., belimumab).
  7. Any previous treatment with T-cell depleting therapies, cladribine, or mitoxantrone.
  8. Treatment with oral cyclophosphamide within 1 year prior to baseline.
  9. Treatment with any investigational drug (including bortezomib) within 24 weeks prior to screening (or within 5 half-lives of the investigational drug; whichever is longer).
  10. Concurrent use of more than one IST (e.g., azathioprine, mycophenolate mofetil, or IV cyclophosphamide) as background therapy.
  11. Contraindication to all of the following rescue treatments: rituximab, IVIG, high-dose corticosteroids, or IV cyclophosphamide.
  12. Any surgical procedure, except laparoscopic surgery or minor surgeries (defined as procedures that require only local anesthesia or conscious sedation, i.e., do not require general, neuraxial or regional anesthesia, and are done on an ambulatory/outpatient basis; e.g. toenail surgery, mole surgical excision, wisdom tooth extraction), within 4 weeks prior to baseline, excluding surgery for thymoma or teratoma removal.
  13. Planned surgical procedure (except minor surgeries) during the study.
  14. Congenital or acquired immunodeficiency, including HIV infection.
  15. Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection (excluding fungal infection of nail beds or dental caries) at baseline.
  16. Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit.
  17. Positive hepatitis B (HBV) or hepatitis C (HCV) test at screening.
  18. Evidence of latent or active tuberculosis (TB).
  19. History of drug or alcohol abuse within 1 year prior to baseline.
  20. Receipt of live or live-attenuated vaccine within 6 weeks prior to baseline visit.
  21. History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening.
  22. History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions).
  23. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening.
  24. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug.