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Trial eligibility change
| eligibility_criteria | Inclusion Criteria: * Clinically diagnosed with Guillain-Barré syndrome (GBS) according to NINDS (National Institute of Neurological Disorders and Stroke) diagnostic criteria * GBS-related weakness beginning within 7 days before the first study treatment * GBS Disability Scale (GBS-DS) score of 3, 4, or 5 at screening and baseline * Was able to walk approximately 10 m or more without assistance before the onset of GBS symptoms * Agrees to receive antibiotic prophylaxis against N. meningitidis and S. pneumoniae for the first 90 days of the study or until a completed vaccination schedule against these bacterial pathogens per local guidelines has been shown. Exclusion Criteria: * History of a previous GBS episode or diagnosis of an atypical GBS variant * Clinical diagnosis of systemic lupus erythematosus (SLE) or known complement deficiency * Autoimmune or neuromuscular diseases or medical conditions (eg, clinically significant renal, hepatic, cardiac, pulmonary, hematologic, or neurological conditions or clinically significant laboratory abnormalities) that would interfere with an accurate assessment of clinical symptoms of GBS, confound the study results, or put the participant at undue risk * IVIg therapy contraindications or another medical condition that, in the opinion of the investigator, would make IVIg administration unsafe * Recent treatment with IVIg or plasma exchange (PLEX), or recent use of certain immune-modulating or immunosuppressive therapies | → | Inclusion Criteria: * Clinically diagnosed with Guillain-Barré syndrome (GBS) according to NINDS (National Institute of Neurological Disorders and Stroke) diagnostic criteria * GBS-related weakness beginning within 7 days before the first study treatment * GBS Disability Scale (GBS-DS) score of 3, 4, or 5 at screening and baseline * Was able to walk approximately 10 m or more without assistance before the onset of GBS symptoms * Agrees to receive antibiotic prophylaxis against N. meningitidis and S. pneumoniae for the first 90 days of the study or until a completed vaccination schedule against these bacterial pathogens per local guidelines has been shown. Exclusion Criteria: * History of a previous GBS episode or diagnosis of an atypical GBS variant * Clinical diagnosis of systemic lupus erythematosus (SLE) or known complement deficiency * Autoimmune or neuromuscular diseases or medical conditions (eg, clinically significant renal, hepatic, cardiac, pulmonary, hematologic, or neurological conditions or clinically significant laboratory abnormalities) that would interfere with an accurate assessment of clinical symptoms of GBS, confound the study results, or put the participant at undue risk * IVIg therapy contraindications or another medical condition that, in the opinion of the investigator, would make IVIg administration unsafe * Recent treatment with IVIg except for a single IVIg dose administered during screening and within 24 hours before the first investigational medicinal product (IMP) dose for the current GBS episode or plasma exchange (PLEX), or recent use of certain immune-modulating or immunosuppressive therapies |
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