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Guillain-Barré SyndromePhase 2GREATNCT07806916

Efficacy and Safety of Efgartigimod in the Treatment of Guillain-Barré Syndrome(GREAT)

A Phase 2 study testing Intravenous immunoglobulin (IVIG) and Efgartigimod Alfa-Fcab in people with Guillain-Barré Syndrome, run by Beijing Tiantan Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Guillain-Barré Syndrome
What is being tested?
Intravenous immunoglobulin (IVIG) and Efgartigimod Alfa-Fcab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
No sites listed yet
Study dates
Sep 2026to Dec 2027
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-70 years
  • Diagnosis of sensorimotor or pure motor Guillain-Barré syndrome (GBS) based on the 2023 EAN/PNS guidelines (corresponding to classical GBS in the Chinese Guidelines for the Diagnosis and Treatment of Guillain-Barré Syndrome 2024).
  • Onset of GBS within 14 days
  • GBS Disability Scale (GBS-DS) score of 3 to 5

Who cannot join

  • Patients with other diagnoses cannot be excluded
  • Patients with recurrent GBS
  • Patients with more than 14 days after onset of symptoms
  • GBS DS of 2 or less
  • Patients unable to cooperate with scale assessments due to psychiatric disorders or impaired consciousness
  • Positive serum test at screening for an active viral infection with any of the following conditions: Hepatitis B virus (HBV) that is indicative of an acute or chronic infection; Hepatitis C virus (HCV) based on HCV antibody assay; Positive HIV serology at screening
Show all 14Show fewer
  • Patients with any known severe bacterial, viral or fungal infection or any major episode of infection that required hospitalization or injectable antimicrobial therapy in the last 8 weeks prior to Screening
  • Total IgG level ≤ 6 g/L at screening
  • Concomitant diseases that can cause peripheral neuropathy, such as metabolic neuropathies (e.g., diabetes, alcoholism), connective tissue disease-associated neuropathies (e.g., rheumatoid arthritis, Sjögren's syndrome, systemic lupus erythematosus), or trauma, which may confound the trial results
  • Subjects with serious underlying diseases, such as cardiac dysfunction, coagulopathy dysfunction
  • Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing
  • Patients who have a history of malignancy, including malignant thymoma, or myeloproliferative or lymphoproliferative disorders, unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 3 years before Screening. Patients with completely excised non-melanoma skin cancer (such as basal cell carcinoma or squamous cell carcinoma) or cervical carcinoma in situ would be permitted at any time
  • Use of investigational drug within 3 months or 5 half-lives of the drug (whichever is longer) prior to Screening
  • Use of immunosuppressants, monoclonal antibodies, or other immunomodulatory drugs within 6 months prior to enrollment; use of corticosteroids at a dose exceeding 20 mg within 3 months prior to enrollment; or use of IVIG or plasma exchange (PE) within 1 month prior to enrollmen

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zaiqiang Zhang Zhang, MD contact

86-10-59975570

ttyy0142011@126.com

About this study

Official title: Efficacy and Safety of Efgartigimod in the Treatment of Guillain-Barré Syndrome: A Prospective, Multicenter, Randomized Controlled Clinical Trial

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

Being tested
Intravenous immunoglobulin (IVIG), Efgartigimod Alfa-Fcab
Keywords
Efgartigimod, Guillain-Barré Syndrome
Medical subject headings
Guillain-Barre Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous immunoglobulin (IVIG)Drug

    IVIg is the standard-of-care treatment for GBS. The same brand of intravenous immunoglobulin (IVIG) was administered across different study sites

  • Efgartigimod Alfa-FcabDrug

    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.

Study groups in NCT07806916
Study groupRoleWhat they receive
Intravenous Immunoglobulin (IVIg)Active comparator0.4g/kg of IVIg daily for 5 days Interventions: Drug: Intravenous Immunoglobulin (IVIg)
Receives: Drug: Intravenous immunoglobulin (IVIG)
Efgartigimod Alfa-FcabExperimental20mg/kg of Intravenous efgartigimod on days 1 and 5 Interventions: Drug: Efgartigimod Alfa-Fcab
Receives: Drug: Efgartigimod Alfa-Fcab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: week 4

  2. Number and seriousness of adverse events

    safety monitoring

    Measured: Through study completion, an average of 2 years

Secondary outcomes (17)

  1. 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.

    Measured: week 1，2，3，8，12，24

  2. 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.

    Measured: week 1,2,3,4,8,12,24

  3. Number of days to GBS-DS ≤2 within 24 weeks

    Measured: 24 weeks

  4. Proportion of patients with GBS-DS ≤2

    Measured: week 1, 2, 3, 4, 8, 12, and 24

  5. Neuropathy Impairment Scale (NIS)

    Peripheral neuropathy assessment. Scores range from 0 to 244, with higher scores indicating a worse outcome

    Measured: week 1,4,8,12,24

  6. Inflammatory Rasch-Built Overall Disability Scale (I-RODS)

    Functional outcome assessment. Scores range from 0 to 48, with higher scores indicating a better outcome

    Measured: week 1,4,8,12,24

  7. 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

    Measured: week 1,4,8,12,24

  8. Medical Research Council Sum Score（MRC-SS）

    Quantifies strength.Scores range from 0 to 60, with a higher score indicating more strength.

    Measured: week 1,4,8,12,24

  9. 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

    Measured: week 1,4,8,12,24

  10. Incidence of assisted mechanical ventilation

    Measured: 24 weeks

  11. Duration of mechanical ventilation (hours)

    Measured: 24 weeks

  12. Number of days in an intensive care unit

    Measured: 24 weeks

  13. Number of days to hospital discharge

    Measured: 24 weeks

  14. 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.

    Measured: 24 weeks

  15. 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.

    Measured: week 4,12,24

  16. Maximal Inspiratory Pressure (MIP)

    Pulmonary function test that evaluates the strength of inspiratory muscles, primarily the diaphragm. Units are cm H2O (centimeters of water)

    Measured: week 4,12,24

  17. Maximal Expiratory Pressure (MEP)

    Pulmonary function test that evaluates the strength of expiratory muscles. Units are cm H2O (centimeters of water).

    Measured: week 4,12,24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07806916
Sponsor's protocol ID
KY2026-050-02
Acronym
GREAT
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intravenous immunoglobulin (IVIG) and Efgartigimod Alfa-Fcab in people with Guillain-Barré Syndrome, run by Beijing Tiantan Hospital.

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 4 inclusion and 14 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Zaiqiang Zhang Zhang, MD (86-10-59975570, ttyy0142011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Guillain-Barre Syndrome Disability Scale (GBS-DS) (time frame: week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07806916.

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 18 Sep 2026.

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