Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT07281456
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Organization:
Study Overview
Official Title:
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren s Disease Phase IIa Open-Label Placebo-Controlled Clinical Trial and Associated Mechanistic Studies
Status:
RECRUITING
Status Verified Date:
2025-12-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Sjogren's disease. Secondary objectives will include investigating the effects of Tofacitinib on target tissues (e.g., salivary gland function), systemic inflammation, and on vascular function in SjD 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 SjD 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 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 SjD individuals with mild to moderate disease.
* To investigate the effects of Tofacitinib on systemic biomarkers of SjD 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 Tofacitinib-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) and number and rates of SjD disease flares.
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.
* Changes in serum cytokines, autoantibody levels (e.g., ANAHep2 substrate, SSA, SSB autoantibody titers), complement proteins C3 and C4, markers of systemic inflammation such as ESR and CRP between baseline and study day 168
As a primary objective, this study represents an innovative investigative measure of the safety and tolerability of JAK inhibition in participants with Sjogren's disease. Secondary objectives will include investigating the effects of Tofacitinib on target tissues (e.g., salivary gland function), systemic inflammation, and on vascular function in SjD 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 SjD 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 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 SjD individuals with mild to moderate disease.
* To investigate the effects of Tofacitinib on systemic biomarkers of SjD 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 Tofacitinib-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) and number and rates of SjD disease flares.
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.
* Changes in serum cytokines, autoantibody levels (e.g., ANAHep2 substrate, SSA, SSB autoantibody titers), complement proteins C3 and C4, markers of systemic inflammation such as ESR and CRP between baseline and study day 168
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 002290-D | None | None | View |