EFG vs IVIG in TAMG

NCT07231523 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: PROMISE-TAMG
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Myasthenia Gravis Activities of Daily Living (MG-ADL) reduction

  From baseline to 2 weeks postoperatively

• Myasthenia Gravis Composite (MGC) reduction

  From baseline to 2 weeks postoperatively

• QMG change (1 day preoperatively)

  From baseline to 1 day preoperatively

• QMG change (1 week postoperatively)

  From baseline to 1 week postoperatively

• QMG change (1 month postoperatively)

  From baseline to 1 month postoperatively

Study Arms (2)

Efgartigimod + Thymectomy

EXPERIMENTAL

Combination Product: Efgartigimod + Thymectomy

Intravenous immunglobulin + Thymectomy

ACTIVE COMPARATOR

Combination Product: Intravenous immunglobulin + Thymectomy

Interventions

Efgartigimod + Thymectomy 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.

Efgartigimod + Thymectomy

Intravenous immunglobulin + Thymectomy 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.

Intravenous immunglobulin + Thymectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• MGFA type V;
• Patients who have undergone median sternotomy;
• 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;
• 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;
• 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;
• History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);
• Patients with peripheral nervous system disorders or significant mental disorders and a history of central nervous system disorders;
• Patients participating in other clinical studies simultaneously;
• Patients who cannot tolerate single-lung ventilation during surgery; severe cardiac complications, cardiovascular decompensation, patients with implanted cardiac pacemakers;
• 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;
• 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;
• Serum IgG level \<4.5 g/L;
• Received biological agents such as rituximab or ibritumomab tiuxetan within 6 months; underwent plasma exchange within 1 month;
• Thrombosis, renal impairment or renal failure;
• Allergic to human immunoglobulin or have other severe allergic history;

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Thymectomy

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Jianyong Ding

CONTACT

+86 18616881268; ding.jianyong@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 17, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)