EfgartigimodPhase 3NCT07231523
EFG vs IVIG in TAMG
A Phase 3 study testing Efgartigimod + Thymectomy and Intravenous immunglobulin + Thymectomy in people with Efgartigimod and Intravenous Immunoglobulin, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Efgartigimod, Intravenous Immunoglobulin, Myasthenia Gravis Associated With Thymoma
- What is being tested?
- Efgartigimod + Thymectomy and Intravenous immunglobulin + Thymectomy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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;
- Selective IgA deficiency with anti-IgA antibodies;
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Jianyong Ding, +86 18616881268, ding.jianyong@zs-hospital.sh.cn
About this study
Official title: 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.
- Being tested
- Efgartigimod + Thymectomy, Intravenous immunglobulin + Thymectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efgartigimod + ThymectomyCombination 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 + ThymectomyCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| Efgartigimod + Thymectomy | Experimental | Not described Receives: Combination Product: Efgartigimod + Thymectomy |
| Intravenous immunglobulin + Thymectomy | Active comparator | Not described Receives: Combination Product: Intravenous immunglobulin + Thymectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative Myasthenia Gravis (QMG) reduction
The total QMG score ranges from 0 to 39, with higher scores indicating more severe condition.
Measured: From baseline to 2 weeks postoperatively
Secondary outcomes (26)
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
Measured: 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.
Measured: From baseline to 2 weeks postoperatively
QMG change (1 day preoperatively)
The change in the QMG score from baseline to 1 day preoperatively
Measured: From baseline to 1 day preoperatively
QMG change (1 week postoperatively)
The change in the QMG score from baseline to 1 week postoperatively
Measured: From baseline to 1 week postoperatively
QMG change (1 month postoperatively)
The change in the QMG score from baseline to 1 month postoperatively
Measured: From baseline to 1 month postoperatively
QMG change (2 months postoperatively)
The change in the QMG score from baseline to 2 months postoperatively
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline to 2 months postoperatively
MGC change (1 day preoperatively)
The change in the MGC score from baseline to 1 day preoperatively
Measured: From baseline to 1 day preoperatively
MGC change (1 week postoperatively)
The change in the MGC score from baseline to 1 week postoperatively
Measured: From baseline to 1 week postoperatively
MGC change (1 month postoperatively)
The change in the MGC score from baseline to 1 month postoperatively
Measured: From baseline to 1 month postoperatively
MGC change (2 months postoperatively)
The change in the MGC score from baseline to 2 months postoperatively
Measured: From baseline to 2 months postoperatively
IgG reduction (1 day preoperatively)
The reduction in the IgG level from baseline to 1 day preoperatively
Measured: From baseline to 1 day preoperatively
IgG reduction (1 week postoperatively)
The reduction in the IgG level from baseline to 1 week postoperatively
Measured: From baseline to 1 week postoperatively
IgG reduction (2 weeks postoperatively)
The reduction in the IgG level from baseline to 2 weeks postoperatively
Measured: From baseline to 2 weeks postoperatively
IgG reduction (1 month postoperatively)
The reduction in the IgG level from baseline to 1 month postoperatively
Measured: From baseline to 1 month postoperatively
IgG reduction (2 months postoperatively)
The reduction in the IgG level from baseline to 2 months postoperatively
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline to 1 month postoperatively
Proportion of steroid dose reduction
The rate of reduction in steroid dose from baseline to 2 months postoperatively
Measured: 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
Measured: Perioperative period
Incidence of total perioperative complications (≥3)
The incidence of total perioperative complications assessed by Clavien-Dindo classification
Measured: Perioperative period
Incidence of perioperative infection-related complications
The incidence of perioperative infection-related complications assessed by Clavien-Dindo classification.
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfgartigimodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tang-Du Hospital, West China Hospital, Second Affiliated Hospital of Soochow University, Huashan Hospital, The Affiliated Brain Hospital of Nanjing Medical University, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Wuhan TongJi Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231523
- Sponsor's protocol ID
- PROMISE-TAMG
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Efficacy and Safety of Efgartigimod Versus Intravenous Immunoglobulin for Thymoma Associated Myasthenia Gravis: a Prospective, Multicenter, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07231523
- Acronym / sponsor ID
- PROMISE-TAMG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Xuzhou Medical University, First Affiliated Hospital of Wenzhou Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Tang-Du Hospital, West China Hospital, Second Affiliated Hospital of Soochow University, Huashan Hospital, The Affiliated Brain Hospital of Nanjing Medical University, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, Wuhan TongJi Hospital
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efgartigimod + Thymectomy | Experimental | Combination Product: Efgartigimod + Thymectomy |
| Intravenous immunglobulin + Thymectomy | Active comparator | Combination Product: Intravenous immunglobulin + Thymectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efgartigimod + ThymectomyPatients 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 | Efgartigimod + Thymectomy |
| Intravenous immunglobulin + ThymectomyPatients 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. | Combination product | Intravenous immunglobulin + Thymectomy |
Primary outcome
Quantitative Myasthenia Gravis (QMG) reduction
Time frame: From baseline to 2 weeks postoperatively
The total QMG score ranges from 0 to 39, with higher scores indicating more severe condition.
26 secondary outcomes
Myasthenia Gravis Activities of Daily Living (MG-ADL) reduction
Time frame: From baseline to 2 weeks postoperatively
Myasthenia Gravis Composite (MGC) reduction
Time frame: From baseline to 2 weeks postoperatively
QMG change (1 day preoperatively)
Time frame: From baseline to 1 day preoperatively
QMG change (1 week postoperatively)
Time frame: From baseline to 1 week postoperatively
QMG change (1 month postoperatively)
Time frame: From baseline to 1 month postoperatively
QMG change (2 months postoperatively)
Time frame: From baseline to 2 months postoperatively
MG-ADL change (1 day preoperatively)
Time frame: From baseline to 1 day preoperatively
MG-ADL change (1 week postoperatively)
Time frame: From baseline to 1 week postoperatively
MG-ADL change (1 month postoperatively)
Time frame: From baseline to 1 month postoperatively
MG-ADL change (2 months postoperatively)
Time frame: From baseline to 2 months postoperatively
MGC change (1 day preoperatively)
Time frame: From baseline to 1 day preoperatively
MGC change (1 week postoperatively)
Time frame: From baseline to 1 week postoperatively
MGC change (1 month postoperatively)
Time frame: From baseline to 1 month postoperatively
MGC change (2 months postoperatively)
Time frame: From baseline to 2 months postoperatively
IgG reduction (1 day preoperatively)
Time frame: From baseline to 1 day preoperatively
IgG reduction (1 week postoperatively)
Time frame: From baseline to 1 week postoperatively
IgG reduction (2 weeks postoperatively)
Time frame: From baseline to 2 weeks postoperatively
IgG reduction (1 month postoperatively)
Time frame: From baseline to 1 month postoperatively
IgG reduction (2 months postoperatively)
Time frame: From baseline to 2 months postoperatively
AChR-Ab reduction (1 day preoperatively)
Time frame: From baseline to 1 day preoperatively
AChR-Ab reduction (2 weeks postoperatively)
Time frame: From baseline to 2 weeks postoperatively
AChR-Ab reduction (1 month postoperatively)
Time frame: From baseline to 1 month postoperatively
Proportion of steroid dose reduction
Time frame: From baseline to 2 months postoperatively
Incidence of myasthenic crisis
Time frame: Perioperative period
Incidence of total perioperative complications (≥3)
Time frame: Perioperative period
Incidence of perioperative infection-related complications
Time frame: Perioperative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Efgartigimod + Thymectomy and Intravenous immunglobulin + Thymectomy in people with Efgartigimod and Intravenous Immunoglobulin, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianyong Ding (+86 18616881268, ding.jianyong@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Myasthenia Gravis (QMG) reduction (time frame: From baseline to 2 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.