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Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome

NCT05701189 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2026-03-12

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of Efgartigimod in patients with Guillain-Barre syndrome (GBS). The main questions it aims to answer are:

* Is Efgartigimod a safe treatment option for GBS patients?
* Does treatment with Efgartigimod improve patient outcomes?

In addition to standard-of-care procedures and assessments, participants will:

* Undergo seven blood draws during hospitalization and in four follow-up study visits to evaluate the concentration of neurofilament light chain, a protein that is elevated in patients with Guillain-Barré syndrome. The presence of neurofilament light chain is believed to be indicative of damage to the nervous system, with higher levels resulting from greater damage.
* Complete the Columbia Suicide Severity Rating Scale (C-SSRS) to monitor any suicidal ideation or behaviors during the course of the study.

Conditions

  • Guillain-Barre Syndrome

Interventions

DRUG

Efgartigimod Alfa-Fcab

Efgartigimod is an anti-neonatal Fc receptor (FcRn) immunoglobulin G1 Fc fragment. The FcRn plans a critical role in extending the half-life of IgGs by rescuing them from lysosomal degradation. Antibodies that bind and subsequently block the FcRn with high affinity result in IgGs being degraded more rapidly instead of salvaged. This approach has been shown to be beneficial in the antibody-mediated disorder myasthenia gravis.

DRUG

Intravenous Immunoglobulin (IVIg)

IVIg is the standard-of-care treatment for GBS. Brand of IVIG used may vary per institutional standards

Sponsors & Collaborators

  • argenx

    collaborator INDUSTRY

  • Chafic Karam

    lead OTHER

Principal Investigators

  • Chafic Karam, MD · Staff Physician and Associate Professor of Clinical Neurology

  • Colin Quinn, MD · Staff Physician and Associate Professor of Clinical Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-10
Primary Completion
2026-01-19
Completion
2026-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701189 on ClinicalTrials.gov