drugset / Trial / NCT05701189

Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome

NCT05701189

Phase 2 Withdrawn Chafic Karam argenx · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2024-09-10
Primary completion
2026-01-19
Completion
2026-02-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Efgartigimod Alfa Protein / enzyme biologic 20 mg/kg Intravenous
Comparator Intravenous Immunoglobulin (IVIg) Protein / enzyme biologic 0.4 g/kg Intravenous