EFG vs IVIG in TAMG

NCT ID: NCT07231523

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2027-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Efgartigimod + Thymectomy

Group Type: EXPERIMENTAL

Efgartigimod + Thymectomy

Intervention Type: COMBINATION_PRODUCT

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.

Intravenous immunglobulin + Thymectomy

Group Type: ACTIVE_COMPARATOR

Intravenous immunglobulin + Thymectomy

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Xuzhou Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: collaborator

Tang-Du Hospital

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Brain Hospital of Nanjing Medical University

OTHER_GOV

Sponsor Role: collaborator

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Wuhan TongJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jianyong Ding

Role: CONTACT

ding.jianyong@zs-hospital.sh.cn

+86 18616881268

Facility Contacts

Jianyong Ding

Role: primary

ding.jianyong@zs-hospital.sh.cn

+86 18616881268

Other Identifiers

PROMISE-TAMG

Identifier Type: -

Identifier Source: org_study_id