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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myasthenia Gravis Associated With Thymoma; Efgartigimod; Intravenous Immunoglobulin
• Intervention / Treatment: Combination product: Efgartigimod + Thymectomy; Combination product: Intravenous immunglobulin + Thymectomy

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jianyong Ding; Phone Number: +86 18616881268; Email: ding.jianyong@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Shanghai Zhongshan Hospital
      • Contact: Jianyong Ding; Phone Number: +86 18616881268; Email: ding.jianyong@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients aged >18 years and ≤75 years, with an expected survival time >12 months;
2. Patients with generalized myasthenia gravis;
3. MG-ADL ≥6;
4. Positive for AChR antibody;
5. Diagnosed with thymoma by enhanced chest CT or MRI;
6. Patients with thymoma combined with myasthenia gravis who are diagnosed by MDT and need to undergo thymectomy;
7. Patients with American Society of Anesthesiologists (ASA) grade 1-2;
8. Able to understand the study situation and sign the Informed Consent.

Exclusion Criteria:

1. MGFA type V;
2. Patients who have undergone median sternotomy;
3. Confirmed history of congestive heart failure; poorly controlled angina pectoris with drug treatment; electrocardiogram (ECG) confirmed transmural myocardial infarction; poorly controlled hypertension; clinically significant valvular heart disease; or high-risk uncontrolled arrhythmia;
4. Patients with weight loss of more than 5kg in the past month; severe uncontrolled systemic disease, such as active infection or poorly controlled diabetes; patients with hemorrhagic diseases and bleeding tendencies; coagulation dysfunction, bleeding tendency or receiving thrombolytic or anticoagulant therapy; patients with grade II-IV bone marrow suppression;
5. Females with positive serum pregnancy test or in lactation period, and males and females of childbearing age who are unwilling to use adequate contraceptive measures during treatment;
6. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
7. Patients with peripheral nervous system disorders or significant mental disorders and a history of central nervous system disorders;
8. Patients participating in other clinical studies simultaneously;
9. Patients who cannot tolerate single-lung ventilation during surgery; severe cardiac complications, cardiovascular decompensation, patients with implanted cardiac pacemakers;
10. Patients in the acute inflammatory period due to bacterial, viral or other microbial infections; known active infections of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), or known HIV seropositivity;
11. Patients who have undergone thoracic surgery due to tuberculous pleurisy, mesothelioma, lung disease, or diaphragmatic disease, with ipsilateral lung atelectasis involving one lobe or more than one lobe;
12. Serum IgG level <4.5 g/L;
13. Received biological agents such as rituximab or ibritumomab tiuxetan within 6 months; underwent plasma exchange within 1 month;
14. Thrombosis, renal impairment or renal failure;
15. Allergic to human immunoglobulin or have other severe allergic history;
16. Selective IgA deficiency with anti-IgA antibodies;
17. Subjects with impaired function of major organs, abnormal blood routine, lung, liver, kidney and cardiac function, and the following laboratory test results:

Blood: white blood cells <4.0×10^9/L, absolute neutrophil count (ANC) <2.0×10^9/L, platelet count <100×10^9/L, hemoglobin <90g/L; Liver function: serum bilirubin >1.5 times the upper normal limit; ALT and AST >1.5 times the upper normal limit; Renal function: serum creatinine (SCr) >120 μmol/L, creatinine clearance rate (CCr) <60 ml/min;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efgartigimod + Thymectomy	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.
Active Comparator: Intravenous immunglobulin + Thymectomy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Myasthenia Gravis (QMG) reduction	The total QMG score ranges from 0 to 39, with higher scores indicating more severe condition.	From baseline to 2 weeks postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myasthenia Gravis Activities of Daily Living (MG-ADL) reduction	The total MG-ADL score ranges from 0 to 24, with higher scores indicating more severe condition	From baseline to 2 weeks postoperatively
Myasthenia Gravis Composite (MGC) reduction	The total MGC score ranges from 0 to 50, with higher scores indicating more severe condition.	From baseline to 2 weeks postoperatively
QMG change (1 day preoperatively)	The change in the QMG score from baseline to 1 day preoperatively	From baseline to 1 day preoperatively
QMG change (1 week postoperatively)	The change in the QMG score from baseline to 1 week postoperatively	From baseline to 1 week postoperatively
QMG change (1 month postoperatively)	The change in the QMG score from baseline to 1 month postoperatively	From baseline to 1 month postoperatively
QMG change (2 months postoperatively)	The change in the QMG score from baseline to 2 months postoperatively	From baseline to 2 months postoperatively
MG-ADL change (1 day preoperatively)	The change in the MG-ADL score from baseline to 1 day preoperatively	From baseline to 1 day preoperatively
MG-ADL change (1 week postoperatively)	The change in the MG-ADL score from baseline to 1 week postoperatively	From baseline to 1 week postoperatively
MG-ADL change (1 month postoperatively)	The change in the MG-ADL score from baseline to 1 month postoperatively	From baseline to 1 month postoperatively
MG-ADL change (2 months postoperatively)	The change in the MG-ADL score from baseline to 2 months postoperatively	From baseline to 2 months postoperatively
MGC change (1 day preoperatively)	The change in the MGC score from baseline to 1 day preoperatively	From baseline to 1 day preoperatively
MGC change (1 week postoperatively)	The change in the MGC score from baseline to 1 week postoperatively	From baseline to 1 week postoperatively
MGC change (1 month postoperatively)	The change in the MGC score from baseline to 1 month postoperatively	From baseline to 1 month postoperatively
MGC change (2 months postoperatively)	The change in the MGC score from baseline to 2 months postoperatively	From baseline to 2 months postoperatively
IgG reduction (1 day preoperatively)	The reduction in the IgG level from baseline to 1 day preoperatively	From baseline to 1 day preoperatively
IgG reduction (1 week postoperatively)	The reduction in the IgG level from baseline to 1 week postoperatively	From baseline to 1 week postoperatively
IgG reduction (2 weeks postoperatively)	The reduction in the IgG level from baseline to 2 weeks postoperatively	From baseline to 2 weeks postoperatively
IgG reduction (1 month postoperatively)	The reduction in the IgG level from baseline to 1 month postoperatively	From baseline to 1 month postoperatively
IgG reduction (2 months postoperatively)	The reduction in the IgG level from baseline to 2 months postoperatively	From baseline to 2 months postoperatively
AChR-Ab reduction (1 day preoperatively)	The reduction in the AChR-Ab level from baseline to 1 day preoperatively	From baseline to 1 day preoperatively
AChR-Ab reduction (2 weeks postoperatively)	The reduction in the AChR-Ab level from baseline to 2 weeks postoperatively	From baseline to 2 weeks postoperatively
AChR-Ab reduction (1 month postoperatively)	The reduction in the AChR-Ab level from baseline to 1 month postoperatively	From baseline to 1 month postoperatively
Proportion of steroid dose reduction	The rate of reduction in steroid dose from baseline to 2 months postoperatively	From baseline to 2 months postoperatively
Incidence of myasthenic crisis	The incidence of postoperative myasthenia gravis crisis, from the start of the trial to the end of the follow-up period	Perioperative period
Incidence of total perioperative complications (≥3)	The incidence of total perioperative complications assessed by Clavien-Dindo classification	Perioperative period
Incidence of perioperative infection-related complications	The incidence of perioperative infection-related complications assessed by Clavien-Dindo classification.	Perioperative period

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Huashan Hospital; West China Hospital; Tang-Du Hospital; Second Affiliated Hospital of Soochow University; First Affiliated Hospital of Wenzhou Medical University; Wuhan TongJi Hospital; The Affiliated Hospital of Xuzhou Medical University; The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; The Affiliated Brain Hospital of Nanjing Medical University; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 24, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Thoracic Surgical Procedures; Thymectomy
• Other Study ID Numbers: PROMISE-TAMG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes