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

Last updated: June 6, 2023
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Completed

Phase

3

Condition

Neurologic Disorders

Neuropathy

Peripheral Neuropathy

Treatment

Placebo

Eculizumab

Clinical Study ID

NCT04752566
ECU-GBS-301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 orFG4 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 IVIgtreatment period.

Exclusion

Exclusion Criteria:

  • Participants who have previously received or are currently receiving treatment withcomplement modulators.
  • Participants who have been administered another investigational product within 30 daysor 5 half-lives (whichever is longer) prior to providing consent or are currentlyparticipating 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 toproviding consent.

Study Design

Total Participants: 57
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
March 08, 2021
Estimated Completion Date:
August 03, 2022

Study 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.

Connect with a study center

  • Clinical Trial Site

    Bunkyo-ku, 113-8519
    Japan

    Site Not Available

  • Clinical Trial Site

    Chiba, 260-8677
    Japan

    Site Not Available

  • Clinical Trial Site

    Fuchu, 183-0042
    Japan

    Site Not Available

  • Clinical Trial Site

    Fukuoka, 814-0180
    Japan

    Site Not Available

  • Clinical Trial Site

    Gifu, 501-1194
    Japan

    Site Not Available

  • Clinical Trial Site

    Hiroshima, 730-8518
    Japan

    Site Not Available

  • Clinical Trial Site

    Kagoshima, 890-8520
    Japan

    Site Not Available

  • Clinical Trial Site

    Kawagoe, 350-8550
    Japan

    Site Not Available

  • Clinical Trial Site

    Kawasaki, 216-8511
    Japan

    Site Not Available

  • Clinical Trial Site

    Kitakyushu, 807-8556
    Japan

    Site Not Available

  • Clinical Trial Site

    Kobe, 650-0047
    Japan

    Site Not Available

  • Clinical Trial Site

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • Clinical Trial Site

    Kurashiki, 710-8602
    Japan

    Site Not Available

  • Clinical Trial Site

    Kyoto, 602-8566
    Japan

    Site Not Available

  • Clinical Trial Site

    Matsumoto, 390-8621
    Japan

    Site Not Available

  • Clinical Trial Site

    Mibu, 321-0293
    Japan

    Site Not Available

  • Clinical Trial Site

    Mitaka, 181-8611
    Japan

    Site Not Available

  • Clinical Trial Site

    Nagoya, 466-8560
    Japan

    Site Not Available

  • Clinical Trial Site

    Niigata, 951-8520
    Japan

    Site Not Available

  • Clinical Trial Site

    Nishinomiya, 663-8501
    Japan

    Site Not Available

  • Clinical Trial Site

    Osakasayama, 589-8511
    Japan

    Site Not Available

  • Clinical Trial Site

    Sagamihara, 252-0375
    Japan

    Site Not Available

  • Clinical Trial Site

    Sapporo, 060-8648
    Japan

    Site Not Available

  • Clinical Trial Site

    Sendai, 983-8520
    Japan

    Site Not Available

  • Clinical Trial Site

    Ube, 755-8505
    Japan

    Site Not Available

  • Clinical Trial Site

    Yokohama, 236-0004
    Japan

    Site Not Available

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