RecruitingPhase 2NCT07281456

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease

Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Disease Phase IIa Open-Label Clinical Trial and Associated Mechanistic Studies

Sponsor

National Institute of Dental and Craniofacial Research (NIDCR)

Enrollment

60 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Sjogren's Syndrome

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether tofacitinib, a pill that calms the immune system, is safe and effective for adults with primary Sjögren's disease — a condition where the immune system attacks moisture-producing glands, causing dry eyes and dry mouth. **You may be eligible if...** - You are an adult with a confirmed diagnosis of primary Sjögren's disease - Your disease activity is mild to moderate - You may be newly diagnosed or may have already tried other immunosuppressive medications beyond antimalarials and steroids - Women and members of minority groups who meet the criteria are especially encouraged to participate **You may NOT be eligible if...** - You have severe or uncontrolled Sjögren's disease - You have conditions that make immune-suppressing drugs unsafe for you - You are not able to commit to the study requirements and follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTofacitinib

XELJANZ(R) is the citrate salt of tofacitinib. Tofacitinib citrate is a white to off-white powder. XELJANZ(R) is supplied for oral administration as 5 mg tofacitinib (equivalent to 8 mg tofacitinib citrate) white round, immediate-release film-coated tablet.