drugset / Trial / NCT04752566

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

NCT04752566

Phase 3 Completed 57 enrolled Alexion Pharmaceuticals, Inc.
RandomizedParallel-groupTriple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Eculizumab Monoclonal antibody Intravenous