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Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome

NCT04496960 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2025-12-18

Study results available
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Summary

Background:

An autoimmune disease is one in which the immune system attacks a person's own body. Sjogren's syndrome (SS) is an autoimmune disease. It often involves multiple systems and organs of the body. Researchers are trying to find new, more effective and safe treatments for SS.

Objective:

To evaluate the safety and tolerance of tofacitinib in people with SS.

Eligibility:

Adults ages 18-75 with SS.

Design:

Participants will be screened on a separate protocol. They will undergo:

* Medical and dental history
* Physical exam
* Medicine review
* Electrocardiogram to test the heart s electrical activity (Participants will lay on a table. Sticky pads will be placed on their body.)
* Eye exam and test for dry eyes
* Oral, head, and neck exams
* Plaque collection (Dental plaques and tongue and mucosal scrapings will be collected using a small tongue depressor.)
* Salivary gland ultrasound
* Blood and urine tests
* Minor salivary gland biopsy (The lower lip will be numbed. Several tiny salivary glands will be removed through a small incision.)
* Saliva collection
* Disease assessment.

Participants will repeat some of the screening tests during the study.

Participants will take capsules of the study drug or a placebo by mouth for 168 days.

Participants will have tests to measure blood pressure and the speed of blood flow through the organs. They will also have a test that examines the function and reaction of the blood vessels. For these tests, they will wear blood pressure cuffs and other sensors.

Participants will complete questionnaires about their health.

Participants will have 9 study visits over 28 weeks. They may be contacted by phone between study visits.

Conditions

  • Sjogren's Syndrome

Interventions

DRUG

tofacitinib

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.

OTHER

Placebo

white, round, film-coated tablet

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    lead NIH

Principal Investigators

  • Blake M Warner, D.D.S. · National Institute of Dental and Craniofacial Research (NIDCR)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2025-01-14
Completion
2026-09-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04496960 on ClinicalTrials.gov