Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease (NCT07281456) | Clinical Trial Compass
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
United States60 participantsStarted 2025-12-18
Plain-language summary
Background:
Sjogren disease is an autoimmune disease - that is, a disease that causes the body's immune system to attack its own organs and tissues. Sjogren disease can affect the kidneys, lungs, or other organs. It can also cause dry mouth and eyes, fever, joint pain, rashes, and other symptoms. Researchers want to know if a drug approved to treat rheumatoid arthritis and other autoimmune diseases can help people with Sjogren disease.
Objective:
To test a drug (tofacitinib) in people with Sjogren disease.
Eligibility:
People aged 18 to 75 years with Sjogren disease. They must be enrolled in protocol 15-D-0051.
Design:
* Participants will be screened. They will have a physical exam with blood and urine tests. They will give samples of saliva; a small sample of tissue will be taken from a salivary gland. They will have a test of their heart function. They will have an eye exam, including a test for dry eyes.
* Tofacitinib is a tablet taken by mouth. Participants will take the drug twice a day at home.
* Participants will have 9 clinic visits over 28 weeks. Each visit will take up to 5 hours. In addition to repeated tests, they will have tests of the speed and pressure of blood flow through their body. They will complete health questionnaires throughout the study.
* Participants will also have 5 phone visits during the study. They will review their health and study treatments.
* They will have 1 final visit after they stop taking the drug.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ability of participant to understand and the willingness to sign a written informed consent document.
. Participation and enrollment in companion protocol, 15-D-0051, Characterization of Diseases with Salivary Gland Involvement.
. Stated willingness to comply with all study procedures and availability for the duration of the study
. Male or female, aged between 18-75 years old
. In good general health as evidenced by medical history
. Meets the 2002 American European Consensus Group classification criteria for Sjogren's disease or 2016 American College of Rheumatology/European League against Rheumatism Classification Criteria (ACR-EULAR) with mild to moderate disease activity defined as ESSDAI between 0 and 13 at the screening visit and \>0 ml/min/gland stimulated saliva flow.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial focused primarily on safety, what does that mean about how much is still unknown regarding whether tofacitinib actually helps with my Sjogren's symptoms — and is that uncertainty something I should be comfortable with?
2The main thing this trial is measuring is how often and how seriously participants experience side effects — given that tofacitinib already has a known safety profile from other conditions like rheumatoid arthritis, what specific risks are you most concerned about for someone with my health history?
3Are there standard treatments for primary Sjogren's disease that I should try first before considering an experimental option like this one, or does my situation make this trial worth exploring sooner?
4What would my day-to-day participation look like if I enrolled — how often would I need to come in for monitoring, and how intensive is the follow-up given that safety tracking is the primary goal?
5If I experience an adverse event during the trial, what is the process for reporting it and adjusting or stopping my treatment, and would I still have access to care through the trial team?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Adverse Events by Grade/Category
Timeframe: Up to Day 196
2
Participants With Adverse Events
Timeframe: Up to Day 196
Trial details
NCT IDNCT07281456
SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
. Ability to take oral medication and be willing to adhere to the study intervention regimen
. If on glucocorticoids, the dose must be less than 10 mg daily and stable for the 4 weeks (28 days) prior to the screening visit.
Exclusion criteria
. Current or prior treatment with rituximab, belimumab, or any other biologic agent in the 6 months prior to screening.
. Current or prior treatment with Tofacitinib for more than 6 months in the last 2 years prior to screening.
. Current treatment with methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, or other less common immunomodulatory drugs such as those falling into the class of disease-modifying antirheumatic drugs (DMARDs), not otherwise specified herein. Participants previously on methotrexate, azathioprine, mycophenolate mofetil, cyclosporine or tacrolimus, or other DMARDs should have withdrawn drug for at least 8 weeks (56 days) at the time of screening. The use of topical or ophthalmic preparations of cyclosporine, tacrolimus, or other DMARDs is permitted and does not require an 8-week withdrawal period.
. Treatment with cyclophosphamide, pulse methylprednisolone or IVIG within 6 months prior to screening.
. Current treatment with potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole) or receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole) that would increase serum availability of Tofacitinib. Past treatment with the agent is allowed if it was more than a week prior to the administration of the first dose of study medication.
. History of chronic liver disease, not including well-controlled Sjogren's-related chronic liver disease or elevated LFTs:
. Serum creatinine \>1.5mg/dL.
. Protein to creatinine ratio of more than 1mg/dL at screening (repeated and confirmed three times or confirmed with 24 hours urine protein of more than 1000mg).