EFG vs IVIG in TAMG

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

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.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  collaborator OTHER

• Tang-Du Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Second Affiliated Hospital of Soochow University

  collaborator OTHER

• Huashan Hospital

  collaborator OTHER

• The Affiliated Brain Hospital of Nanjing Medical University

  collaborator OTHER_GOV

• The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

  collaborator OTHER

• Wuhan TongJi Hospital

  collaborator OTHER

• Shanghai Zhongshan Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2027-06-01

Completion

2027-12-01

FDA Drug

Yes

Countries

• China

Study Locations