A Longitudinal, Observational Biomarker Study in Participants With Primary Sjogren's Syndrome

A Biomarker Study to Determine the Gene Expression Signatures of Salivary Gland and Blood in Subjects With Incident Primary Sjögren's Syndrome, Subjects With Sicca, and Healthy Volunteers

The main objective of the study is to characterize the gene expression in immune and epithelial cells in salivary gland biopsy samples and blood of pSS (primary Sjögren's syndrome) and non-pSS participants including healthy volunteers.

Key Inclusion Criteria:

For Healthy Volunteers:

• In good overall health as determined by the Investigator For Participants With Sicca
• Subjects should present with sicca (i.e., dry eyes and dry mouth) at Baseline
• Must be willing to undergo a minor salivary gland (labial) biopsy

Key Exclusion Criteria:

• A history of any clinically significant medical condition, as determined by the Investigator, that may impact study analyses
• A chronic or persistent infection human immunodeficiency virus (HIV), hepatitis B, hepatitis C, and/or tuberculosis
• Pre-existing connective tissue disease or autoimmune disease, such as systemic lupus erythematosus (SLE), rheumatoid arthritis, systemic sclerosis, or sarcoidosis
• Any known contraindications of sialoscintigraphy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply