A Study of Imlifidase in Patients With Guillain-Barré Syndrome

Exclusion Criteria

• •1. Previous treatment with imlifidase.
• •2. Previous IVIg treatment within 28 days prior to imlifidase treatment.
• •3. Subjects who are being considered for, or already on, PE.
• •4. Women of child-bearing potential willing or able to use at least one highly effective contraceptive method from the screening visit until at least 180 days following imlifidase dosing.
• •5. Breastfeeding or pregnancy
• •6. Clinical evidence of a polyneuropathy of another cause e.g. diabetes mellitus (except mild sensory), alcoholism, vitamin deficiency, or porphyria.
• •7. Known selective immunoglobulin A (IgA) deficiency.
• •8. Hypersensitivity to IVIg or to any of the excipients.
• •9. Immunosuppressive treatment (e.g. azathioprine, cyclosporine, mycophenolate mofetil, tacrolimus, sirolimus or \> 20 mg prednisolone daily) during the last month.
• •10. Subject known to have a severe concurrent disease, e.g. malignancy, severe cardiovascular disease and severe chronic obstructive pulmonary disease (COPD).
• •11. Any condition that in the opinion of the investigator could increase the subject's risk by participating in the study or confound the outcome of the study.
• •12. Known mental incapacity or language barriers precluding adequate understanding of the Informed Consent information and the study activities.
• •13. Subjects with clinical signs of ongoing infection.
• •14. Subjects should not have received other investigational drugs within 5 half-lives prior to imlifidase dosing.
• •15. Present or history of thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP.
• •16. Positive PCR test for SARS-CoV-2 virus infection.