Efgartigimod for the Treatment of Acute Optic Neuritis

Exclusion Criteria

• •1. Current pregnancy or lactation
• •2. Known allergic reactions or intolerance to efgartigimod, methylprednisolone, prednisone, or gadolinium or any of their components
• •3. Known diagnosis of optic neuropathy preceding the current episode of optic neuritis
• •4. Evidence of a systemic disease other than MS, NMOSD, or MOGAD that might be associated with the optic neuritis
• •5. Receiving systemic immunomodulatory or immunosuppressive therapy at the time of enrollment or planned receipt within 3 weeks of treatment. Initiation of immunotherapy more than 3 weeks after the second dose of efgartigimod is not an exclusion criterion and is permitted.
• •6. Known diagnosis of CNS demyelinating disease (MS, NMOSD, MOGAD) prior to present attack.
• •7. Any visually-significant ocular pathology (i.e. retinal problems, cataracts, glaucoma etc.) in the affected eye that led to known best-corrected visual acuity deficits in participants prior to onset of optic neuritis. Congenital color-blindness is not disqualifying.
• •8. Alternative explanation for visual changes detected on fundoscopic exam and slit lamp examination.
• •9. Enrollment in another clinical study involving an investigational treatment given within 2 months of enrollment in the present study.
• •10. Contraindication to MRI or plasma exchange
• •11. Has received \>3 days of high-dose steroids (IV or PO) for the treatment of the current episode of acute optic neuritis by the time of randomization. Randomization may occur at the latest on the next day after completion of 3rd dose of steroids.
• •12. Known HIV disease or common variable immunodeficiency
• •13. History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥1 year before the first administration of IMP. Adequately treated participants with the following cancers may be included at any time:
• •1. Basal cell or squamous cell skin cancer
• •2. Carcinoma in situ of the cervix
• •3. Carcinoma in situ of the breast
• •4. Incidental histological finding of prostate cancer (TNM stage T1a or T1b)
• •14. Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection
• •15. Clinically significant recent major surgery (within 1 month of screening), or intends to have surgery during the study
• •16. Any conditions or circumstances that in the opinion of the investigator may put the participant at undue risk, confound the results of the study, or otherwise make the participant unsuitable for the study.