Immune

Primary Sjogren Syndrome

Also known as primary Sjogren's, sicca syndrome, autoimmune exocrinopathy

Primary Sjogren Syndrome is a chronic systemic autoimmune disease driven by lymphocytic infiltration of exocrine glands, particularly salivary and lacrimal glands, causing the hallmark features of dry eyes (keratoconjunctivitis sicca) and d

ORPHA:289390 ↗Prevalence 60-100 in 100,000; predominantly female (9:1 ratio)Onset Middle adulthood; predominantly women aged 40-60Systemic autoimmune exocrinopathy

11

studies recruiting now

as of 7 Sept 2026

31

studies registered in total

as of 7 Sept 2026

17

countries with a recruiting site

as of 7 Sept 2026

15 Dec 2025

most recent study posted

among recruiting studies

Recruiting trials

Showing the 5 most recently updated recruiting studies, as recorded 7 Sept 2026. Live status on each study page.

See all 11 recruiting studies

Where recruiting studies are running

Countries with at least one recruiting site among the studies above, 7 Sept 2026. Tap a country to search trials there.

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About Primary Sjogren Syndrome

Primary Sjogren Syndrome is a chronic systemic autoimmune disease driven by lymphocytic infiltration of exocrine glands, particularly salivary and lacrimal glands, causing the hallmark features of dry eyes (keratoconjunctivitis sicca) and dry mouth (xerostomia), with frequent extraglandular manifestations affecting joints, lung, kidney, peripheral nervous system, and skin. Serological hallmarks include anti-Ro/SSA and anti-La/SSB autoantibodies, elevated polyclonal immunoglobulins, and cryoglobulins, with a markedly increased risk of non-Hodgkin B-cell lymphoma compared to the general population. Targeted biologics including belimumab, ianalumab, and CD40 pathway inhibitors are under active investigation in clinical trials.

Common clinical features

Persistent dry eyes with foreign body sensationXerostomia with difficulty chewing and swallowingParotid gland enlargementInflammatory arthralgia and non-erosive arthritisFatigue (often severe and disproportionate)Peripheral and autonomic neuropathyRenal tubular acidosis from tubulointerstitial nephritis

From Orphanet’s phenotype annotations (CC BY 4.0). Not a complete list.

Treatments being studied

3 approved treatments and 48 in clinical development, from Open Targets (CC BY 4.0). Not medical advice.

Approved: CevimelineApproved: BromhexineApproved: Pilocarpine (Ocusert pilo)
Phase 3Hydroxychloroquine
Phase 3Sodium Chloride (Aqsia (balanced salt soln))
Phase 3Abatacept (Orencia)
Phase 3Ianalumab
Phase 3Dazodalibep
Phase 3Deucravacitinib (Sotyktu)
Phase 3Telitacicept
Phase 3Nipocalimab

+ 40 more in development

Before you apply

Things trial teams commonly ask about for Primary Sjogren Syndrome. Not eligibility rules; those are set by each study.

  • Fulfillment of 2016 ACR/EULAR classification criteria (score ≥4) with positive lip biopsy or anti-Ro/SSA serology is typically required; gather biopsy pathology, salivary flow measurements, and Schirmer test results
  • ESSDAI score (disease activity) and ESSPRI score (patient-reported symptoms) are the standard outcome measures; baseline scores are often used as eligibility thresholds — ask your rheumatologist to calculate these at your next visit
  • Lymphoma history is a common exclusion criterion; if you have had cryoglobulinemic vasculitis or lymphoproliferative complications, disclose these at screening as they may affect eligibility differently across trials

Related conditions

Information, not medical advice. Trial listings are shown as recorded on ClinicalTrials.gov; whether any study is right for you is a decision for you and your clinicians, and eligibility is decided by each research team. Disease information from Orphanet (CC BY 4.0).