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

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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