AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed Informed Consent obtained before any study-related procedures.
✓. Willingness and ability to comply with the protocol.
✓. Male or female aged ≥18 years at the time of screening.
✓. GBS diagnosed according to National Institute of Neurological Disorders and Stroke (NINDS) diagnostic criteria (Asbury et al. 1990).
✓. Onset of weakness due to GBS is not more than 10 days prior to screening.
✓. Unable to walk unaided for \>10 meters (grade ≥ 3 on GBS DS).
✓. IVIg treatment being considered.
✓. Women of child-bearing potential willing or able to use at least one highly effective contraceptive method from the day of treatment until at least 6 months after the dose of imlifidase if not abstinent. In the context of this study, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.
Exclusion criteria
✕. Previous treatment with imlifidase.
✕. Previous IVIg treatment within 28 days prior to imlifidase treatment.
✕. Subjects who are being considered for, or already on, PE.
✕. 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.
✕. Clinical evidence of a polyneuropathy of another cause e.g. diabetes mellitus (except mild sensory), alcoholism, vitamin deficiency, or porphyria.
✕. Known selective immunoglobulin A (IgA) deficiency.
✕. Hypersensitivity to IVIg or to any of the excipients.
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Days in Hospital
Timeframe: Baseline to Day 360
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Time in an ICU
Timeframe: Baseline until Day 360
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Need for Mechanical Ventilation
Timeframe: Baseline until Day 180
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Patient's Health State Over Time as Assessed by EQ VAS
Timeframe: Day 8, Day 15, Day 29, Day 57, Day 92, Day 180, and Day 360