The main purpose of this study is to learn whether empasiprubart, when given in addition to intravenous immunoglobulin (IVIg), helps adults with Guillain-Barré syndrome (GBS) recover and whether it is safe. About 63 participants will be assigned by chance to receive either empasiprubart or placebo by intravenous infusion; all participants will also receive IVIg. The study includes screening for up to 72 hours, study treatment through Day 12, and follow-up through Week 67 (15 months after the last dose of study treatment). Participation lasts up to 67 weeks.
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
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
Parallel
Empasiprubart IV
Biological/VaccineIntravenous infusion of Empasiprubart
Empasiprubart Placebo IV
Other interventionIntravenous infusion of Placebo
Intravenous immunoglobulin (IVIg)
Biological/VaccineIntravenous infusion of IVIg
Proportion of Participants With a Guillain-Barré Syndrome Disability Scale (GBS-DS) Score ≤2 at Week 4
The Guillain-Barré Syndrome Disability Scale (GBS-DS) is a clinician-reported measure of global functional disability. It has 7 categories ranging from 0 (healthy) to 6 (death), with higher scores indicating greater disability. A GBS-DS score ≤2 indicates the participant is able to walk 10 meters or more without assistance.
Number of calendar days in the intensive care unit (ICU) within the first 4 weeks of investigational medicinal product (IMP) administration
ICU means intensive care unit; IMP means investigational medicinal product
Number of calendar days receiving invasive mechanical ventilation within the first 4 weeks of investigational medicinal product (IMP) administration
IMP means investigational medicinal product
Time From First Investigational Medicinal Product (IMP) Administration to Achieving a Guillain-Barré Syndrome Disability Scale (GBS-DS) Score ≤2
IMP means investigational medicinal product; The Guillain-Barré Syndrome Disability Scale (GBS-DS) is a clinician-reported measure of global functional disability with 7 categories ranging from 0 (healthy) to 6 (death), with higher scores indicating greater disability.
Actual values in the Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Scores at weeks 13 and 26
The Inflammatory Rasch-Built Overall Disability Scale (I-RODS) is a 24-item participant-reported measure of disability that assesses limitations in activities and social participation. Raw scores range from 0 to 48 and are converted to a centile metric score ranging from 0 (most severe activity and social participation limitations) to 100 (no activity and social participation limitations). Higher scores indicate less disability.
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