The goal of this open label study is to measure pharmacokinetics, pharmacodynamics, early efficacy, and safety of tanruprubart in adult and pediatric participants, in the United States, Canada, and Europe.
Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for GBS.
Onset of GBS-related weakness ≤10 days before start of infusion on Day 1
GBS-disability score (DS) score of 3, 4, or 5 at screening and before start of infusion on Day 1.
Previous or intended treatment with either plasma exchange or IV immunoglobulin for GBS.
Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.
Single group
Tanruprubart
DrugSolution for IV infusion.
Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t)
Observed Time to Maximum Observed Serum Concentration (Cmax) (Tmax) of Tanruprubart
Change From Baseline in Free Component of Complement Complex (C1q) Protein Concentration in Serum
Change from Baseline in Medical Research Council (MRC) Sumscore at Week 1
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