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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy, Sicca Syndrome, Sjögren's Syndrome

Intervention / Treatment
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* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subgroup 1<br>Healthy Volunteers - subset of which 10 will receive salivary gland biopsy. | Procedure: Biopsy<br>* Salivary Gland<br>|
| Subgroup 2<br>Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with positive biopsy result. | Procedure: Biopsy<br>* Salivary Gland<br>|
| Subgroup 3<br>Diagnosis of pSS based on the criteria of the American-European Consensus Criteria for Sjögren's Syndrome (AECCSS) with negative biopsy result. | Procedure: Biopsy<br>* Salivary Gland<br>|
| Subgroup 4<br>Presenting with sicca but not satisfying the criteria of the AECCSS for diagnosis of pSS. | Procedure: Biopsy<br>* Salivary Gland<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers |  | Up to 12 months | 
| Gene expression levels in immune cells (innate and adaptive) in blood samples from participants with and without pSS including healthy volunteers |  | Up to 12 months | 
| Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers |  | Up to 12 months | 
| Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers |  | Up to 12 months |