A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome

Inclusion Criteria:

• Is at least 18 years of age and the local legal age of consent for clinical studieswhen signing the ICF.

• Meets the following criteria at screening: ACR/EULAR classification criteria 2016PSjD; clinESSDAI ≥ 6; Anti-Ro/SS-A positive at central laboratory; Unstimulatedresidual salivary flow (≥ 0.01 mL/min)

Exclusion Criteria:

• Secondary Sjögren's disease where another confirmed autoimmune rheumatic or systemicinflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus,scleroderma, and inflammatory bowel disease) is the primary diagnosis.

• Active fibromyalgia which is not adequately controlled in the judgment of theinvestigator, or participant is receiving fibromyalgia treatment that has not beenstable treatment for at least 12 weeks before screening.

• Any severe systemic PSjD manifestation that is not adequately controlled at baselinethat may put the participant at undue risk based on the investigator's opinion.

• Use of cyclophosphamide ≤ 24 weeks prior to screening

• Anti-CD20 or anti-CD19 antibody received < 6 months before screening