drugset / Trial / NCT06221501

Perioperative Efgartigimod for Thymoma and Myasthenia Gravis

NCT06221501

Phase 2 Not yet recruiting 30 enrolled Shanghai Zhongshan Hospital
NaSingle-groupOpen-labelTreatment

Summary

It is evidenced that efgartigimod can rapidly and significantly improve the symptoms of myasthenia gravis. The global multicenter clinical trials hace confirmed that efgartigimod is safe and well tolerated. Few case reports showed that perioperative efgartigimod combined with thymectomy was safe and feasible. However, there was no sufficient data on safety and efficacy of this regimen in the treatment for patients with myasthenia gravis and thymomas. Therefore, this trial aims to evaluate the efficacy and safety of perioperative efgartigimod and thymectomy for patients with myasthenia gravis and thymomas.

Timeline

Start
2024-02-01
Primary completion
2026-12-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Efgartigimod Alfa Protein / enzyme biologic 10 mg/kg Intravenous

Indications