Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 12:44 AM
Study NCT ID:
NCT04496960
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2020-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
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 Syndrome; a Phase Ib-IIa Placebo-controlled Clinical Trial and Associated Mechanistic Studies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12-03
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:
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.
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.
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 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 |
|---|---|---|---|---|
| 20-D-0131 | None | None | View |