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:
  Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (mogad)
• Age: Between 12 Year(s) - 99 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Able to provide written informed consent form. If participant is under 18 years old, they must be able to provide assent and their parent/legal guardian must be able to provide consent
  2. Confirmed diagnosis of MOGAD meeting the following criteria:
     • Documented history of =MOGAD attacks (first attack and at least 1 relapse) manifesting with the following presentations/syndromes: optic neuritis; transverse myelitis; acute disseminated encephalomyelitis (ADEM); other brain, brainstem, or cerebellar syndrome compatible with demyelination; and any combination of the above
     • Diagnosis of MOGAD attacks based on the new or worsening, acute neurologic symptoms with an objective change on neurologic and/or ophthalmologic examination that persisted for more than 24 hours, AND
     • Serum positivity for MOG-IgG by a CBA, AND
     • Exclusion of alternative diagnoses, including MS
  3. Confirmed serum positivity for MOG-IgG at screening as assessed by a central laboratory
  4. Body weight =20kg at screening
  5. Expanded Disability Status Scale (EDSS) score of 0 - 6.5 at screening
  6. BCVA better than 20/800 in both eyes at screening
  7. History of =1 MOGAD relapse in the 12 months prior to screening or =2 attacks (may include the first attack) in the 24 months prior to screening
  8. Participants receiving either no ongoing chronic IST for MOGAD at the time of screening or receiving ongoing treatment with azathioprine (AZA), mycophenolate mofetil (MMF), oral corticosteroid (OCS) or a combination of AZA or MMF and OCS prior to screening
  9. Participants entering the study on a stable dose of AZA or MMF alone or in combination with OCS must have experienced at least one MOGAD attack prior to screening while using AZA or MMF for =3 months
  10. No contraindications to corticosteroids and at least one of the two other rescue treatments (IVIg or PLEX)
  11. No contraindications to MRI
  12. For women of childbearing potential: participants who agree 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

  
  

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

• 1. Presence of AQP4-IgG in the serum
  2. History of encephalitis unrelated to MOGAD
  3. Dawson’s finger-type T2/FLAIR hyperintense lesions
  4. Participants who have experienced a MOGAD relapse within 12 weeks prior to baseline, unless their EDSS is 0 at screening
  5. Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or IV corticosteroids at doses >20 mg prednisone equivalent per day for >21 days during the study
  6. Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
  7. Participants who have any surgical procedure (except for minor surgeries defined as procedures requiring only local anesthesia or conscious sedation and are done on an ambulatory/outpatient basis; e.g., toenail surgery, mole surgical excision, tooth extraction) within 4 weeks prior to baseline
  8. Participants who are planning to have surgical procedure (except minor surgeries) during the study
  9. Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection (excluding fungal infection of nail beds or dental caries) at baseline
  10. Infection requiring treatment with IV anti-infective agents within 4 weeks prior to baseline
  11. Evidence of progressive multifocal leukoencephalopathy
  12. Participants with evidence of latent or active tuberculosis (TB)
  13. Participants with positive screening tests for hepatitis B
  14. Participants with positive screening test for hepatitis C
  15. Participants with congenital or acquired immunodeficiency, including HIV infection
  16. Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
  17. History of diverticulitis or concurrent severe gastrointestinal (GI) disorders (such as symptomatic diverticulosis) that, in the investigator's opinion, may lead to increased risk of complications such as GI perforation
  18. History of blood donation (1 unit or more), plasma donation or platelet donation within 90 days prior to screening
  19. History of malignancy within the last 5 years prior to baseline, including solid tumors, hematologic malignancies and in situ carcinoma
  20. History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions)
  21. History of drug or alcohol abuse within 1 year prior to baseline
  22. Active suicidal ideation within 6 months prior to screening or history of suicide attempt within 3 years prior to screening
  23. Participants who have had any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
  24. Laboratory test findings are outside the acceptable ranges