Sjogren's SyndromePhase 1/2NCT04496960
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
A Phase 1/2 study testing tofacitinib in people with Sjogren's Syndrome, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- tofacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2021to 22 Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult primary SS participants with mild-to-moderate disease activity will be eligible for this study. Enrolled participants can be naïve or failed immunosuppressive therapy beyond antimalarials and glucocorticoids; to prevent bias in the cohort of participants with more recalcitrant disease. We expect that Tofacitinib is a potential second line therapy, in addition to antimalarials and glucocorticoids, depending on the participant's initial presentation and response. Women and members of minority groups, if eligible, will be included in accordance with the NIH Policy on Inclusion of Women and Minorities as Participants in Research Involving Human Participants.
- In order to be eligible to participate in this study, an individual must meet all of the following 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
Show all 14Show fewer
- In good general health as evidenced by medical history
- Meets the 2002 American European Consensus Group classification criteria for primary Sjogren's Syndrome 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 to 13 at the screening visit and >0 ml/min/gland stimulated saliva flow.
- 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 screening visit.
- If on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, the dose must have been stable for the 12 weeks (96 days) prior to screening visit. The maximum allowed dose is hydroxychloroquine up to 400 mg/day or 6.5 mg/kg/day if more than 400 mg/day. The maximum allowed dose for chloroquine phosphate is up to 500 mg daily and for quinacrine up to 100 mg daily.
- Participants may be on lipid lowering medications if initiated at least 3 months prior to the screening visit and dose must be stable for 4 weeks (28 days) prior to study entry.
- Males and females with potential for reproduction must agree to practice effective birth control measures. Females should be on adequate contraception if they are of child-bearing potential documented by a clinician, unless participants or spouse have previously undergone a sterilization procedure. Adequate birth control measures are: intrauterine device (IUD) alone or hormone implants, hormone patches, injectable, or oral contraceptives plus a barrier method (male condom, female condom or diaphragm), abstinence or a vasectomized partner.
- Agreement to adhere to Lifestyle Considerations throughout study duration
Who cannot join
- In order to be eligible to participate in this study, an individual must not meet any of the following criteria:
- Current or prior treatment with rituximab, belimumab or any other biologic agent in the 6 months 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.
- 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 aforementioned 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 liver function tests (LFT):
Show all 39Show fewer
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 2x upper limit of normal at screening
- Serum unconjugated bilirubin > 2mg/dL at screening
- 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).
- Active urinary sediment (WBC, red blood cell (RBC) or mixed cellular casts 1+ or more /hpf)).
- Hypercholesterolemia: Values after 8-12 hour fasting blood specimen: total cholesterol >250 mg/dL or LDL >180 mg/dL or hypertriglyceridemia (triglyceride >300 mg/dL) within-45 days of screening visit.
- WBC <2500/microliter or absolute neutrophil count (ANC) <1,000/microliter, Hgb <9.0 g/dL or platelets <70,000/microliter or absolute lymphocyte count < 500/microliter.
- Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test at screening.
- A history of drug or alcohol abuse within the 6 months prior to screening.
- Currently receiving hemodialysis, peritoneal dialysis, or intestinal dialysis.
- Active infection that requires the use of oral or intravenous antibiotics unresolved at least 14 days prior to the administration of the first dose of study medication.
- Active chronic infections including but not limited to HIV, Hepatitis B, Hepatitis C, and BK viremia at screening visit.
- Current or previous diagnosis of malignant disease, except for basal cell or squamous cell carcinoma of the skin with complete excision and clear borders or adequately treated in situ carcinoma of the cervix.
- Known active tuberculosis. Participants with treated latent tuberculosis (LTB) will be eligible to participate. Participants with untreated LTB will not be excluded but will be evaluated by an infectious disease (I.D.) consultant and may become eligible for trial based on infectious disease consultant recommendations.
- History of severe or systemic infection caused by common pathogens, or history of infection with pathogens that normally do not cause human disease.
- Participants with active renal or central nervous system disease or a high activity level in any organ system (except articular) in ESSDAI.
- Participants with known increased risk factors for major adverse cardiac event (MACE) including a history of:
- Ischemic heart disease (e.g., history of acute myocardial infarction)
- Heart failure
- Cardiomyopathy
- Severe valvular heart disease
- Significant arrhythmias
- Chronic renal failure
- Cerebrovascular accident or transient ischemic attack
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- Current smokers or former smokers with less than 3 years since complete cessation and/or >20 pack-years of smoking history.
- Significant impairment of major organ function (lung, heart, liver, kidney) or any condition that, in the opinion of the Investigator, would jeopardize the participant's safety following exposure to the study drug.
- Known history of arterial or venous thrombosis or at high risk for clotting disorder
- Psychiatric illness or history of medical non-compliance that the study team feels will make the patient unlikely to complete the study
- Uncontrolled thyroid disease as per PI or medically responsible investigator.
- Known allergic reactions to Tofacitinib or its components
- Treatment with another investigational drug/intervention within six months except for COVID-19 vaccines or therapies that have been granted an FDA emergency authorization.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome; a Phase Ib-IIa Placebo-controlled Clinical Trial and Associated Mechanistic Studies
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.
Read more
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.
Read the detailed description
Study Description:
As a primary objective, this study represents an innovative investigative measure of the safety and tolerability of JAK inhibition in participants with primary Sjogren's syndrome. Secondary objectives will include investigating the effects of Tofacitinib on target tissues (e.g., salivary glands), systemic inflammation, and on vascular function in SS participants. We also aim to identify biomarkers of response that may be useful as endpoints in future studies.
Objectives:
Primary Objective:
-To determine the safety and tolerability of Tofacitinib in participants with SS and mild to moderate disease activity.
Secondary Objectives:
- To assess clinical improvement after treatment with Tofacitinib as measured by changes in the European League Against Rheumatism (EULAR) Sjogren's syndrome Disease Activity Index (ESSDAI) and no worsening on the Physician s Global assessment Scale (PGA).
- To demonstrate that treatment with Tofacitinib is effective clinically and biologically in SS individuals with mild to moderate disease.
- To investigate the effects of Tofacitinib on systemic biomarkers of SS as measures biological effects that can be used as outcome measures to power a larger Clinical Trial.
Endpoints:
Primary Endpoint:
-Safety and tolerability will be measured by assessment of adverse events (AEs) and clinical safety laboratory tests throughout the study. Toxicity is defined as any study drug-related Grade 3 adverse event or higher (as measured by the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0).
Secondary Endpoints:
Preliminary assessments of clinical response will be measured by:
- Changes in the ESSDAI score between Baseline and Day 168 (end of treatment)
- Changes in the Physician's Global Assessment (PGA) scores between baseline and study day 168.
- Conditions
- Sjogren's Syndrome
- Being tested
- tofacitinib, Placebo
- Keywords
- Salivary, Dry Mouth, Safety, Inflammation, Xerostomia
- Medical subject headings
- Sjogren's Syndrome, Xerostomia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tofacitinibDrug
Also called Xeljanz
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.
PlaceboOther
white, round, film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| Drug: Tofacitinib | Experimental | Sjogren's Disease (SjD) patients with mild to moderate disease activity receive tofacitinib 5 mg orally twice daily for 168 days. Receives: Drug: tofacitinib |
| Placebo | Placebo comparator | Sjogren's Disease (SjD) patients with mild to moderate disease activity receive placebo orally twice daily for 168 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events by Grade/Category
Count of adverse events by grade was assessed using the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL.
Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Grade 4: Life-threatening consequences; urgent intervention indicated.
Grade 5: Death related to adverse event.
Serious is defined as any grade 3 or higher adverse event.
Toxicity is defined as any study drug-related Grade 3 or higher adverse event.
Measured: Up to day 196
Participants With Adverse Events
Number participants with any adverse events by grade and severity was assessed using the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activity of daily living (ADL).
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Grade 4 Life-threatening consequences; urgent intervention indicated.
Grade 5 Death related to adverse event.
Serious is defined as any grade 3 or higher adverse event.
Toxicity is defined as any study drug-related Grade 3 or higher adverse event.
Measured: Up to day 196
Secondary outcomes (5)
Change in Physicians Global Assessment (PGA) Score
The Physician Global Activity (PGA) is a subjective physician reported disease activity index that uses a 10-cm Visual Analog Scale (VAS) to score a patient's disease activity. The 10-cm visual analogue scale (VAS) was scored by a physician with a vertical line on the scale marking disease activity where 0 cm indicates no evidence of disease activity, and 10 cm indicates severe disease activity, with score reported on a scale from 0-10. Higher score indicates more disease activity. Change in disease activity index was measured as the mean difference in disease activity scores between time points. Data was analyzed as the change in score between day 1 (baseline) and study day 168 (Change = day 168 - day 1) for the treatment/placebo groups as repeated measures.
Measured: Day 168 minus day 1
Change in EULAR Sjögren's Syndrome (SS) Disease Activity Index (ESSDAI) Score
The EULAR Sjögren's syndrome (SS) disease activity index (ESSDAI) is a systemic disease activity index designed to measure disease activity in patients with primary SS. It includes 12 organ domains (e.g., constitutional, glandular, neurological) for disease activity, each with a 4-point scale (0 = No activity; 3=High activity). These scores are then multiplied by domain-specific weights (1-6) and summed to produce a total score ranging from 0 to 123, with higher scores indicating greater disease activity. Data was analyzed as the change in score between day 1 (baseline) and study day 168 (Change = day 168 - day 1) for the treatment/placebo groups as repeated measures.
Measured: Day 168 minus day 1
Change in Whole Unstimulated Saliva Flow
Changes in salivary flow was assessed by measuring whole unstimulated saliva flow (WUS) and glandular parotid and submandibular/sublingual unstimulated and 0.2% citric acid stimulated flow rates using ultrasonograph. Validated scoring criteria was used to assess ultrasonographic feature parameters at baseline and at the study day 168. Data was analyzed as the change in score between day 1 (baseline) and study day 168 (Change = day 168 - day 1) for the treatment/placebo groups as repeated measures.
Measured: Day 168 minus day 1
Change in Whole Stimulated Saliva Flow
Changes in salivary flow was assessed by measuring whole stimulated saliva flow and glandular parotid and submandibular/sublingual stimulated and 0.2% citric acid stimulated flow rates using ultrasonograph. Validated scoring criteria was used to assess ultrasonographic feature parameters at baseline and at the study day 168. Data was analyzed as the change in score between day 1 (baseline) and study day 168 (Change = day 168 - day 1) for the treatment/placebo groups as repeated measures.
Measured: Day 168 minus day 1
Change in EULAR Sjögren's Syndrome (SS) Patient Reported Index (ESSPRI)
The EULAR Sjögren's Syndrome (SS) Patient Reported Index (ESSPRI) is a patient-reported outcome measure (PROM) that focuses on the subjective experience of symptoms in SS. The tool assesses the key symptoms of dryness, pain and fatigue. A single 0-10 numerical scale is used to assess each of these symptoms. Final score is the average of the scores from the three domains. A final ESSPRI score of less than 5 is considered indicative of acceptable disease status, while a score of 5 or higher suggests high disease activity. Questionnaire was completed at baseline and day 168. Data was analyzed as
Measured: Day 168 minus day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start18 May 2021
- Primary completion14 Jan 2025
- Study completion22 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Blake M Warner, D.D.S., Principal investigator, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496960
- Sponsor's protocol ID
- 200131
- Other IDs
- 20-D-0131
- Status last verified
- 3 Dec 2025
- First submitted
- 2 Aug 2020
- Last updated
- 18 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study complies with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome; a Phase Ib-IIa Placebo-controlled Clinical Trial and Associated Mechanistic Studies
- ClinicalTrials.gov ID
- NCT04496960
- Acronym / sponsor ID
- 200131
- Conditions
- Sjogren's Syndrome
- Keywords
- Salivary, Dry Mouth, Safety, Inflammation, Xerostomia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (actual)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 18 May 2021 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 22 Sep 2026 (estimated)
- First posted
- 4 Aug 2020 (actual)
- Results
- Posted 18 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
As a primary objective, this study represents an innovative investigative measure of the safety and tolerability of JAK inhibition in participants with primary Sjogren's syndrome. Secondary objectives will include investigating the effects of Tofacitinib on target tissues (e.g., salivary glands), systemic inflammation, and on vascular function in SS participants. We also aim to identify biomarkers of response that may be useful as endpoints in future studies.
Objectives:
Primary Objective:
-To determine the safety and tolerability of Tofacitinib in participants with SS and mild to moderate disease activity.
Secondary Objectives:
- To assess clinical improvement after treatment with Tofacitinib as measured by changes in the European League Against Rheumatism (EULAR) Sjogren's syndrome Disease Activity Index (ESSDAI) and no worsening on the Physician s Global assessment Scale (PGA).
- To demonstrate that treatment with Tofacitinib is effective clinically and biologically in SS individuals with mild to moderate disease.
- To investigate the effects of Tofacitinib on systemic biomarkers of SS as measures biological effects that can be used as outcome measures to power a larger Clinical Trial.
Endpoints:
Primary Endpoint:
-Safety and tolerability will be measured by assessment of adverse events (AEs) and clinical safety laboratory tests throughout the study. Toxicity is defined as any study drug-related Grade 3 adverse event or higher (as measured by the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0).
Secondary Endpoints:
Preliminary assessments of clinical response will be measured by:
- Changes in the ESSDAI score between Baseline and Day 168 (end of treatment)
- Changes in the Physician's Global Assessment (PGA) scores between baseline and study day 168.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Tofacitinib | Experimental | Drug: tofacitinibSjogren's Disease (SjD) patients with mild to moderate disease activity receive tofacitinib 5 mg orally twice daily for 168 days. |
| Placebo | Placebo comparator | Other: PlaceboSjogren's Disease (SjD) patients with mild to moderate disease activity receive placebo orally twice daily for 168 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult primary SS participants with mild-to-moderate disease activity will be eligible for this study. Enrolled participants can be naïve or failed immunosuppressive therapy beyond antimalarials and glucocorticoids; to prevent bias in the cohort of participants with more recalcitrant disease. We expect that Tofacitinib is a potential second line therapy, in addition to antimalarials and glucocorticoids, depending on the participant's initial presentation and response. Women and members of minority groups, if eligible, will be included in accordance with the NIH Policy on Inclusion of Women and Minorities as Participants in Research Involving Human Participants.
- In order to be eligible to participate in this study, an individual must meet all of the following 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
Key exclusion criteria (39 listed)
- In order to be eligible to participate in this study, an individual must not meet any of the following criteria:
- Current or prior treatment with rituximab, belimumab or any other biologic agent in the 6 months 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.
- 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 aforementioned agent is allowed if it was more than a week prior to the administration of the first dose of study medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tofacitinibAlso: XeljanzXELJANZ(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. | Drug | Drug: Tofacitinib |
| Placebowhite, round, film-coated tablet | Other | Placebo |
Primary outcome
Number of Adverse Events by Grade/Category
Time frame: Up to day 196
Count of adverse events by grade was assessed using the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event. Serious is defined as any grade 3 or higher adverse event. Toxicity is defined as any study drug-related Grade 3 or higher adverse event.
Participants With Adverse Events
Time frame: Up to day 196
Number participants with any adverse events by grade and severity was assessed using the National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activity of daily living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to adverse event. Serious is defined as any grade 3 or higher adverse event. Toxicity is defined as any study drug-related Grade 3 or higher adverse event.
5 secondary outcomes
Change in Physicians Global Assessment (PGA) Score
Time frame: Day 168 minus day 1
Change in EULAR Sjögren's Syndrome (SS) Disease Activity Index (ESSDAI) Score
Time frame: Day 168 minus day 1
Change in Whole Unstimulated Saliva Flow
Time frame: Day 168 minus day 1
Change in Whole Stimulated Saliva Flow
Time frame: Day 168 minus day 1
Change in EULAR Sjögren's Syndrome (SS) Patient Reported Index (ESSPRI)
Time frame: Day 168 minus day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study complies with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blake M Warner, D.D.S. principal investigator
National Institute of Dental and Craniofacial Research (NIDCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing tofacitinib in people with Sjogren's Syndrome, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events by Grade/Category (time frame: Up to day 196). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.