Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT04035668) enrolled 73 people with Sjögren's Syndrome — a condition that affects the immune system and causes dryness, pain, and fatigue. Participants were randomly assigned to one of three groups: remibrutinib taken twice daily (24 people), remibrutinib taken once daily (25 people), or a placebo (an inactive treatment, 24 people). The trial ran for 24 weeks and was primarily measuring changes in a standardised disease activity score called the ESSDAI, which rates how active Sjögren's Syndrome is across 12 body systems on a scale of 0 to 123 (higher scores mean more active disease). A number of other scores — covering patient-reported symptoms, fatigue, quality of life, and the treating doctor's overall assessment — were also tracked as secondary measures. The reported data shows that on the primary measure (the ESSDAI score at 24 weeks), all groups showed a reduction from their starting scores, meaning scores moved in a lower — or less active — direction. The once-daily remibrutinib group showed a reported change of −4.70 points, the twice-daily group −3.70 points, and when both remibrutinib groups were combined the figure was −4.20 points. The placebo group showed a reported change of −1.34 points. On the secondary measures, the reported data shows that scores for patient-reported symptoms (ESSPRI), fatigue (FACIT-F), general health (EQ-5D), and doctor-rated disease activity (PhGA) also changed across all groups over the course of the trial, with the numbers varying between groups and across different time points. Some of these changes were small and the direction of change was not always consistent across groups at every time point. It is worth noting that this was a relatively small study — roughly 24–25 people per group — and a number of participants did not complete the trial (7 in the twice-daily group, 8 in the once-daily group, and 3 in the placebo group). The reported data does not include information about why participants left the trial early. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 37932009) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Sjogren's Syndrome Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with Sjögren's Syndrome (a condition that affects moisture-producing glands) based on the 2016 international diagnostic guidelines
- Your Sjögren's Syndrome is active enough to score at least 5 points on a specific disease activity assessment used by doctors (called the ESSDAI), based on 8 areas of the body
- You score at least 5 out of 10 on a patient-reported symptom scale measuring dryness, fatigue, and pain (called the ESSPRI)
- A blood test shows you have a specific antibody called anti-Ro/SSA, tested at or within 3 months before the screening visit
- You are still able to produce some saliva, even if just a very small amount
Who may not be able to join:
- You have Sjögren's Syndrome alongside another autoimmune disease that is considered your main condition
- You have taken certain immune-suppressing or targeted medications (called DMARDs or kinase inhibitors) within the 3 months before the study start, above certain doses, or plan to continue them during the study
- You have received Rituximab or a similar drug that reduces a type of immune cell (B cells) within the past 12 months before your screening visit
- You are currently taking more than 15mg per day of prednisone (a steroid) or have changed your steroid dose in the 2 weeks before screening
- You are currently taking any medication known to cause dry mouth or dry eyes as a major side effect
- You have HIV, Hepatitis B, Hepatitis C, or a known or suspected history of an ongoing, long-term, or repeatedly occurring infection such as tuberculosis
⚠️ Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change From Baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Total Score at Week 24
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.