A Phase 2 interventional study of Efgartigimod Alfa in Myasthenia Gravis, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
Among 20 studies testing efgartigimod alfa in Myasthenia Gravis — 11 open to participants now, 14 under way, 7 of them phase 3. efgartigimod alfa · Myasthenia Gravis.
Among the 20 studies testing efgartigimod alfa in Myasthenia Gravis, this one is the 12th largest by planned enrollment, is one of 5 that started in 2024, is one of 3 in phase 2, reaches primary completion later than 6 of the 13 other live ones, and was the 8th registered.
330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.
Browse Myasthenia Gravis studies →11 of the 20 studies testing efgartigimod alfa in Myasthenia Gravis are open now, in 12 countries. Recruiting first, the newest first:
argenx · Sites in United States, Belgium, Germany and 5 more countries
Ages 18+
Centre Hospitalier Universitaire de Nice · Sites in France
Ages 65+
argenx · Sites in United States
Ages 18+
University of Colorado, Denver · Sites in United States
Ages 18+
Clinique Neuro-Outaouais · Sites in Canada
Ages 18–80
By country, each count listing its studies:
efgartigimod alfa: first FDA approval 2021 (VYVGART), first EMA approval 2022. What it is approved for, and how studies give it, is on its page →
Of the 104 Myasthenia Gravis studies recruiting now, 64 (62%) set no upper age limit and 23 (22%) stop at 75 or younger; 16 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 5 · Phase 3 12 · Phase 4 4
First in 2016; this study’s year is marked. 5 started in 2024.
This study's planned enrollment of 30 is below the median of 44 across 217 interventional studies indexed under Myasthenia Gravis.
Median enrollment 55 across the 20 interventional studies. Of the 6 that completed or were terminated, 6 (100%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 20 have an industry lead sponsor. The 8 most frequent:
Shanghai Zhongshan Hospital is the lead sponsor of 652 studies on the registry; 291 are open to participants now.
Shanghai Zhongshan Hospital has 2 studies filed under Myasthenia Gravis — fewer than ten, so there is no comparison to draw.
7 of the studies testing efgartigimod alfa in Myasthenia Gravis that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06765161Phase 3Clinique Neuro-OutaouaisEfgartigimod in IVIG Dependent Myasthenia Gravis Patients | 2027-01-06 |
| NCT04833894Phase 3argenxEvaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis | 2027-03 |
| NCT07231523Phase 3Shanghai Zhongshan HospitalEFG vs IVIG in TAMG | 2027-06-01 |
| NCT06392386Phase 3argenxA Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis | 2027-09 |
| NCT06221501Shanghai Zhongshan HospitalPerioperative Efgartigimod for Thymoma and Myasthenia Gravis | 2026-12-30 |
Add all 7 to your calendar (.ics) → With an account.
Among the 20 studies testing efgartigimod alfa in Myasthenia Gravis, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
It is evidenced that efgartigimod can rapidly and significantly improve the symptoms of myasthenia gravis. The global multicenter clinical trials hace confirmed that efgartigimod is safe and well tolerated. Few case reports showed that perioperative efgartigimod combined with thymectomy was safe and feasible. However, there was no sufficient data on safety and efficacy of this regimen in the treatment for patients with myasthenia gravis and thymomas. Therefore, this trial aims to evaluate the efficacy and safety of perioperative efgartigimod and thymectomy for patients with myasthenia gravis and thymomas.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Efgartigimod will be administered intravenously on Day (D)1, D8, D15, and D22 at a dose of 10 mg/kg according to the patient's weight (maximum infusion dose of 1200 mg) over approximately 1 hour for a total of 4 doses. Thymectomy will be performed on Day 9.
Change of the activity of daily living (ADL) score at the fourth visit from the baseline visit (first visit)
The value was calculated by the ADL score at the fourth visit minus the ADL score at the first visit (baseline).
Time frame: Baseline and 3 weeks after the first visit.
Change of the ADL score at the second visit from the baseline visit (first visit)
The value was calculated by the ADL score at the second visit minus the ADL score at the first visit (baseline).
Time frame: Baseline and 1 day before surgery (always at the 1 week after the first visit).
Change of quantitative myasthenia gravis (QMG) score at the second visit from the baseline visit (first visit)
The value was calculated by the QMG score at the second visit minus the QMG score at the first visit (baseline).
Time frame: Baseline and 1 day before surgery (always at the 1 week after the first visit).
Change of myasthenia gravis composite (MGC) score at the second visit from the baseline visit (first visit)
The value was calculated by the MGC score at the second visit minus the MGC score at the first visit (baseline).
Time frame: Baseline and 1 day before surgery (always at the 1 week after the first visit).
Change of QMG score at the fourth visit from the baseline visit (first visit)
The value was calculated by the QMG score at the fourth visit minus the QMG score at the first visit (baseline).
Time frame: Baseline and 3 weeks after the first visit.
Change of MGC score at the fourth visit from the baseline visit (first visit)
The value was calculated by the MGC score at the fourth visit minus the MGC score at the first visit (baseline).
Time frame: Baseline and 3 weeks after the first visit.
Change of lgG-AChR level at the fourth visit from the baseline visit (first visit)
The value (percent) was calculated by the lgG-AChR level at the fourth visit minus the lgG-AChR level score at the first visit (baseline).
Time frame: Baseline and 3 weeks after the first visit.
The rate of postoperative myasthenia crisis
Time frame: From the day when trial begin to the day when the follow-up is ended. Up to 48 weeks.
Postoperative hospital stay
Time frame: From the day when trial begin to the day when the follow-up is ended. Up to 48 weeks.
No study locations are listed for this record.
Start is estimated for Feb 2024; primary completion for Dec 2026, 34 months later.
Of 22 phase 2 interventional studies under Myasthenia Gravis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 30. This study's planned 34 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Efgartigimod alfa