A Study of the Efficacy and Safety of Efgartigimod in Patients with Primary Sjögren's Syndrome (pSjD) (UNITY)

Prior treatment

• Active fibromyalgia which is not adequately controlled in the judgment of the investigator, or participant is receiving fibromyalgia treatment that has not been stable treatment for at least 12 weeks before screening.
• Use of cyclophosphamide ≤ 24 weeks prior to screening
• Anti-CD20 or anti-CD19 antibody received < 6 months before screening

Other illness

• Secondary (also referred to as associated) Sjögren’s disease, defined as overlap with another autoimmune rheumatic or systemic inflammatory condition (eg, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or idiopathic inflammatory myopathy).

Other

• Any severe systemic pSjD manifestation that is not adequately controlled at screening or baseline that may put the participant at undue risk based on the investigator’s opinion.

• Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
• Meets the following criteria at screening: ACR/EULAR classification criteria 2016 pSjD; clinESSDAI ≥ 6; Anti-Ro/SS-A positive at central laboratory; Unstimulated residual salivary flow (≥ 0.01 mL/min)