A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome

Summary

This is a Phase 3, prospective, multicenter, placebo controlled, double blind, randomized study to investigate the efficacy and safety of eculizumab in participants with severe GBS, defined using the Hughes Functional Grade (FG) scale as progressively deteriorating FG3 or FG4/FG5 within 2 weeks from onset of weakness due to GBS. This study will be conducted only at sites in Japan.

Timeline

Start

2021-03-08

Primary completion

2022-08-03

Completion

2022-08-03

Outcome

Missed primary endpoint

registry analysis (superiority test); Eculizumab vs Placebo; p = 0.8938; Hazard Ratio (HR) 0.9 (95% CI 0.45 to 1.97); Log Rank NCT04752566 ↗

Drugs

Indications