It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.

Today, we have a look at a selection of active clinical trials on Sjögren's Disease/Syndrome, the former being the modernized phrasing. All trials featured below are Phase 3, based in the United States, all of which are currently recruiting or anticipated to complete within the next two years. 

Quick View Table of Sjögren's Disease Clinical Trials
Study TitleRecruiting?Estimated EnrollmentStudy StartEstimated Primary Completion
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden (THALASSA)Yes570July 2026August 2029
Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)Yes250February 2026December 2028
A Long-Term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)Yes844February 2025December 2029
Nipocalimab in Moderate to Severe Sjogren's Disease (DAFFODIL)No655December 2024January 2028
A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom StateNo434April 2024October 2026
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)No774September 2023November 2026
Featured Clinical Trials

Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden (THALASSA)

  • Sponsor: Novartis Pharmaceuticals
  • Goal: The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.
  • Interventions: VAY736, placebo
  • Primary Outcome Measure: Change from baseline in SSSD oral dryness score.
  • Time Frame: Baseline to week 52.
  • Study Details
  • Source

Phase 3 Study of Telitacicept in Active Primary Sjögren's Disease (UPSTREAM SjD)

  • Sponsor: Vor Biopharma
  • Goal: [This trial is a] Phase 3 study of telitacicept in active primary Sjögren's disease.
  • Interventions: Telitacicept, placebo
  • Primary Outcome Measure: To evaluate the efficacy of telitacicept versus placebo at Week 48 in the change from baseline in the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 48.
  • Time Frame: Week 48.
  • Study Details
  • Source

A Long-Term Extension Study of Dazodalibep in Participants With Sjögren's Syndrome (SS)

  • Sponsor: Amgen
  • Goal: The primary objective of this study is to evaluate the long-term safety and tolerability of dazodalibep.
  • Interventions: Dazodalibep
  • Primary Outcome Measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs). 
  • Time Frame: Up to 152 weeks.
  • Study Details
  • Source

Nipocalimab in Moderate to Severe Sjogren's Disease (DAFFODIL)

  • Sponsor: Janssen Research & Development
  • Goal: The purpose of this study is to evaluate the clinical efficacy and safety of nipocalimab in participants with moderate to severe Sjogren's disease (SjD).
  • Interventions: Nipocalimab, placebo, standard of care treatment
  • Primary Outcome Measure: Change from Baseline in Clinical European League Against Rheumatism Sjogren's Syndrome Disease Activity Index (ClinESSDAI) Score at Week 48
  • Time Frame: Baseline to week 48
  • Study Details
  • Source

A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

  • Sponsor: Amgen
  • Goal: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state.
  • Interventions: Dazodalibep, placebo
  • Primary Outcome Measures: Change from baseline in ESSPRI score; Change from baseline in diary for assessing sjogren’s patient reported index (DASPRI) score.
  • Time Frames: At week 48; At week 48.
  • Study Details
  • Source

A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)

  • Sponsor: Bristol-Myers Squibb
  • Goal: The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
  • Interventions: Deucravacitinib, placebo
  • Primary Outcome Measure: Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) score at Week 52.
  • Time Frame: Baseline, week 52.
  • Study Details
  • Source
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