A Phase 2 interventional study of Intravenous immunoglobulin (IVIG) and Efgartigimod Alfa-Fcab in Guillain-Barré Syndrome, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Beijing Tiantan Hospital · Phase 2, Interventional, and Treatment
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The goal of this clinical trial is to evaluate the safety and effectiveness of Efgartigimod in patients with Guillain-Barre syndrome (GBS). The main questions it aims to answer are:
Is Efgartigimod a safe treatment option for GBS patients? Does treatment with Efgartigimod improve patient outcomes?
Participants will:
Take drug Efgartigimod or Intravenous Immunoglobulin during hospitalization Undergo six blood draws in six follow-up study visits to evaluate the concentration of IgG Keep a diary of their symptoms and drugs using at the same time
98 studies on the registry are indexed under Guillain-Barre Syndrome; 30 are open to participants now.
This study's planned enrollment of 110 is above the median of 50 across 44 interventional studies indexed under Guillain-Barre Syndrome.
Browse Guillain-Barre Syndrome studies →Beijing Tiantan Hospital is the lead sponsor of 491 studies on the registry; 295 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.4g/kg of IVIg daily for 5 days Interventions: Drug: Intravenous Immunoglobulin (IVIg)
Drug: Intravenous immunoglobulin (IVIG)
20mg/kg of Intravenous efgartigimod on days 1 and 5 Interventions: Drug: Efgartigimod Alfa-Fcab
Drug: Efgartigimod Alfa-Fcab
IVIg is the standard-of-care treatment for GBS. The same brand of intravenous immunoglobulin (IVIG) was administered across different study sites
Efgartigimod is an anti-neonatal Fc receptor (FcRn) immunoglobulin G1 Fc fragment. The FcRn plans a critical role in extending the half-life of IgGs by rescuing them from lysosomal degradation. Antibodies that bind and subsequently block the FcRn with high affinity result in IgGs being degraded more rapidly instead of salvaged. This approach has been shown to be beneficial in the antibody-mediated disorder myasthenia gravis.
Guillain-Barre Syndrome Disability Scale (GBS-DS)
Scoring system that assesses the functional status of GBS subjects. Scores range from 0 to 6, with higher scores indicating a worse outcome.
Time frame: week 4
Number and seriousness of adverse events
safety monitoring
Time frame: Through study completion, an average of 2 years
Guillain-Barre Syndrome Disability Scale (GBS-DS)
Scoring system that assesses the functional status of GBS subjects. Scores range from 0 to 6, with higher scores indicating a worse outcome.
Time frame: week 1，2，3，8，12，24
Change from baseline in Guillain-Barre Syndrome Disability Scale (GBS-DS)
Scoring system that assesses the functional status of GBS subjects. Scores range from 0 to 6, with higher scores indicating a worse outcome.
Time frame: week 1,2,3,4,8,12,24
Number of days to GBS-DS ≤2 within 24 weeks
Time frame: 24 weeks
Proportion of patients with GBS-DS ≤2
Time frame: week 1, 2, 3, 4, 8, 12, and 24
Neuropathy Impairment Scale (NIS)
Peripheral neuropathy assessment. Scores range from 0 to 244, with higher scores indicating a worse outcome
Time frame: week 1,4,8,12,24
Inflammatory Rasch-Built Overall Disability Scale (I-RODS)
Functional outcome assessment. Scores range from 0 to 48, with higher scores indicating a better outcome
Time frame: week 1,4,8,12,24
Inflammatory Neuropathy Cause and Treatment (INCAT) Scale
Functional outcome assessment. Scores range from 0 to 5 for upper limbs or lower limbs, with higher scores indicating a worse outcome
Time frame: week 1,4,8,12,24
Medical Research Council Sum Score（MRC-SS）
Quantifies strength.Scores range from 0 to 60, with a higher score indicating more strength.
Time frame: week 1,4,8,12,24
Modified Rankin Scale (mRS)
Modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scores range from 0 to 6,with higer scores indicating a worse outcome
Time frame: week 1,4,8,12,24
Incidence of assisted mechanical ventilation
Time frame: 24 weeks
Duration of mechanical ventilation (hours)
Time frame: 24 weeks
Number of days in an intensive care unit
Time frame: 24 weeks
Number of days to hospital discharge
Time frame: 24 weeks
Hospitalization cost (inpatient cost)
CNY (Chinese Yuan) Total direct medical costs incurred during the index hospitalization for the study disease, including bed fees, medications, laboratory and imaging tests, nursing, and medical materials, as recorded in the hospital billing system or inpatient settlement records.Indirect costs (e.g., lost productivity, transportation, caregiver costs) are not included unless otherwise specified.
Time frame: 24 weeks
Forced Vital Capacity (FVC)
Pulmonary function test that measures the maximum amount of air you can forcibly exhale from your lungs after fully inhaling. Units are Liters and percentages, when comparing to a predicted value.
Time frame: week 4,12,24
Maximal Inspiratory Pressure (MIP)
Pulmonary function test that evaluates the strength of inspiratory muscles, primarily the diaphragm. Units are cm H2O (centimeters of water)
Time frame: week 4,12,24
Maximal Expiratory Pressure (MEP)
Pulmonary function test that evaluates the strength of expiratory muscles. Units are cm H2O (centimeters of water).
Time frame: week 4,12,24
Study effect of Efgartigimod on IgG levels
Blood sample to analyze change in IgG levels
Time frame: week 1, 2, 3 ,4 ,8 ,12 ,24
No study locations are listed for this record.
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Efgartigimod alfa