Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Eculizumab in Guillain-Barré Syndrome
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Guillain-Barre Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
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 s...
Eligibility Criteria
Inclusion
- Participants who meet the GBS criteria.
- Participants who were able to run prior to onset of GBS symptoms.
- Participants with onset of weakness due to GBS \< 2 weeks before screening.
- Participants unable to walk unaided for ≥ 5 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT04752566
Start Date
March 8 2021
End Date
August 3 2022
Last Update
September 8 2025
Active Locations (22)
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1
Research Site
Bunkyō City, Japan, 113-8519
2
Research Site
Chiba, Japan, 260-0877
3
Research Site
Fukuoka, Japan, 814-0180
4
Research Site
Hiroshima, Japan, 730-8518