NCT07231523

EFG vs IVIG in TAMG

Perioperative Efficacy and Safety of Efgartigimod Versus Intravenous Immunoglobulin for Thymoma Associated Myasthenia Gravis: a Prospective, Multicenter, Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multi-center, randomized controlled study to evaluate the efficacy and safety of efgartigimod (EFG) and intravenous immunoglobulin (IVIG) in the perioperative application for acetylcholine receptor (AChR) antibody-positive thymoma patients with myasthenia gravis in order to provide reliable evidence for clinical decision-making.

Conditions

• Efgartigimod
• Intravenous Immunoglobulin
• Myasthenia Gravis Associated With Thymoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Efgartigimod + Thymectomy	Patients receive weight-based EFG infusions (10 mg/kg; fixed 1200 mg for ≥120 kg) administered over 1 hour once weekly for 4 total doses. If a scheduled infusion is missed, EFG may be administered within 48 hours of the planned time, followed by resumption of the original schedule to complete all 4 infusions. Thymectomy is performed on the day following the second EFG infusion with a permitted ±3-day surgical window.
COMBINATION_PRODUCT	Intravenous immunglobulin + Thymectomy	Patients receive weight-based IVIG infusions (400 mg/kg) administered daily for 5 consecutive days. Thymectomy is performed approximately 7 days after completing the final IVIG infusion, with a permitted ±3-day surgical window.

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2025-11-17
• Last updated: 2025-11-17

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study