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

A Phase 3 Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barre Syndrome

Ishida Hirokazu

Alexion Pharma GK

3-1-1 Shibaura, Minato-ku, Tokyo 108-0023, Japan

JPDept-DevOps-PMCO@alexion.com

Ishida Hirokazu

Alexion Pharma GK

3-1-1 Shibaura, Minato-ku, Tokyo 108-0023, Japan

+81-3-3457-9559

JPDept-DevOps-PMCO@alexion.com

Not Recruiting

Mar. 08, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Participants who meet the GBS criteria.
- Participants who are able to run prior to onset of GBS symptoms.
- Participants with onset of weakness due to GBS less than 2 weeks before screening.
- Participants unable to walk unaided for 5 or more meters (progressively deteriorating FG3 or FG4 to FG5).
- Participants who are already on IVIg or deemed eligible for and who will start IVIg.
- Participants who can start their first dose of study drug before the end of the IVIg treatment period.

- Participants who have previously received or are currently receiving treatment with complement modulators.
- Participants who have been administered another investigational product within 30 days or 5 half-lives (whichever is longer) prior to providing consent or are currently participating in another interventional study.
- Participants who have received rituximab within 12 weeks prior to screening.
- Participants who are being considered for or are already on plasmapheresis.
- Participants who have received immunosuppressive treatment during the 4 weeks prior to providing consent.

Both

Guillain-Barre Syndrome

Eculizumab will be administered via IV infusion at a dose of 900 mg once a week for 4 weeks.
Placebo will be administered via IV infusion once a week for 4 weeks.

Time to first reaching a Hughes Functional Grade (FG) score 1 or less

- Proportion of patients with a Hughes FG score 1 or less at Week 24
- Proportion of patients with a Hughes FG score improvement of 3 or more at Week 24
- Proportion of patients with a Hughes FG score 1 or less at Week 8
- Incidence of treatment-emergent adverse events
- Free complement component 5 (C5) in serum
- Hemolytic complement activity in serum
- Hospital length of stay (LOS)
- Duration of ventilator support
- Concentration of eculizumab in serum
- Incidence of ADAs

+81-3-5803-5612

Dec. 22, 2020

No

none