NCT04752566

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

A Phase 3, Prospective, Multicenter, Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Eculizumab in Patients With Guillain-Barré Syndrome (GBS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible participants will be randomized to receive intravenous (IV) infusion of eculizumab or placebo at a 2:1 ratio. All participants will be on concomitant IV immunoglobulin G (Ig) therapy as per standard of care.

Conditions

• Guillain-Barre Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Eculizumab	Eculizumab will be administered via IV infusion once a week for 4 weeks.
DRUG	Placebo	Placebo will be administered via IV infusion once a week for 4 weeks.

Timeline

• Start date: 2021-03-08
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2021-02-12
• Last updated: 2025-09-08
• Results posted: 2024-02-09

Locations

22 sites across 1 country: Japan