NCT06221501

Perioperative Efgartigimod for Thymoma and Myasthenia Gravis

Safety and Efficacy of Perioperative Efgartigimod Combined With Thymectomy for Thymoma and Myasthenia Gravis: A Prospective, Single-arm Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Efgartigimod Alfa	Efgartigimod will be administered intravenously on Day (D)1, D8, D15, and D22 at a dose of 10 mg/kg according to the patient's weight (maximum infusion dose of 1200 mg) over approximately 1 hour for a total of 4 doses. Thymectomy will be performed on Day 9.

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-12-30
• Completion: 2027-06-30
• First posted: 2024-01-24
• Last updated: 2024-01-24

Regulatory

• FDA-regulated drug study