A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Exclusion Criteria

• •Known autoimmune disease or any medical condition that, in the investigator's judgment,would interfere with an accurate assessment of clinical symptoms of pSS or puts the participant at undue risk
• •History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥3 years before the first administration of IMP.
• •Adequately treated participants with the following cancers may be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer (TNM stage T1a or T1b) Clinically significant uncontrolled active acute or chronic bacterial, viral, or fungal infection
• •Positive serum test at screening for an active infection with any of the following: HBV that is indicative of an acute or chronic infection, unless associated with a negative HBsAg or negative HBV DNA test; HCV based on HCV antibody assay unless a negative RNA test is available; HIV based on test results of a CD4 count of \<200 cells/mm3 that are associated with an AIDS-defining condition, HIV based on test results of a CD4 count of \>200 cells/mm3 not adequately treated with antiviral therapy
• •Clinically significant disease, recent major surgery (within 3 months of screening), or intention to have surgery during the study; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
• •Immunoglobulin G (IgG) levels cannot be below a certain threshold ( 4g/L)
• •Positive covid test at study start
• •Some of the medications such as vaccines with live components or medicines that may be prescribed cannot be taken either shortly before or during this study
• •Current participation in another interventional clinical study or previously participation in an efgartigimod clinical study and treatment with ≥1 dose of IMP
• •Known hypersensitivity to IMP or 1 of its excipients
• •History (within 12 months of screening) of current alcohol, drug, or medication abuse as assessed by the investigator
• •Pregnant or lactating state or intention to become pregnant during the study
• •Secondary Sjögren's syndrome overlap syndromes where another confirmed autoimmune rheumatic or systemic inflammatory condition is the primary diagnosis
• •Chinese traditional medicine with known immunomodulatory action