drugset / Trial / NCT07806916

Efficacy and Safety of Efgartigimod in the Treatment of Guillain-Barré Syndrome(GREAT)

NCT07806916 ↗

Phase 2 Not yet recruiting 110 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupSingle-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? Participants will: Take drug Efgartigimod or Intravenous Immunoglobulin during hospitalization Undergo six blood draws in six follow-up study visits to evaluate the concentration of IgG Keep a diary of their symptoms and drugs using at the same time

Timeline

Start
2026-09
Primary completion
2027-06
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Efgartigimod Alfa Protein / enzyme biologic 20 mg/kg Intravenous
Comparator Intravenous immunoglobulin Protein / enzyme biologic 0.4 g/kg Intravenous