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)

Alexion Pharma GK.0 个研究点目标入组 57 人开始时间: 2021年3月8日最近更新: 2025年6月24日

试验速览

暂无简介。

•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.

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(Week 24)
Proportion of patients with a Hughes FG score improvement of 3 or more at Week 24(Week 24)
Proportion of patients with a Hughes FG score 1 or less at Week 8(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

发起方

Alexion Pharma GK.