Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
NCT03159936
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Adult Trials: 18+ Years
- Adults 18 years to ≤ 65 years of age with clinical diagnosis of DLE (and at least half of patients with a diagnosis of SLE) as determined by the Principal Investigator by medical history and physical exam.
- Able to understand consent procedure
- Able to comply with protocol activities
- Have had a diagnosis of biopsy proven DLE for at least 6 months prior to Visit 1 (Baseline/Day 1).
- At Screening and Visit 1 (Baseline/Day 1), have had DLE covering at least 5% of total body surface area (BSA) or SLE with DLE covering at least 2% of BSA as determined by the hand print method (one palm is equivalent to 1% BSA).
- Patients not able to understand consent procedure
- Patients unable to comply with protocol activities
- Other skin conditions at Baseline that would interfere with evaluation of DLE.
- Topical corticosteroid within the past 2 weeks
- Systemic therapy is allowed if on a stable dose and using for at least 3 months
-background therapies outlined in Protocol
- Concomitant use of moderate to potent inhibitors and inducers of CYP3A4/5
- Women who are pregnant or wish to become pregnant, or who are lactating. Women of
childbearing potential must use effective contraceptive methods in order to
participate in tofacitinib clinical studies
- History of infection requiring hospitalization, parenteral antimicrobial therapy
within 6 months prior to first dose of study drug or history of infection requiring
antimicrobial therapy within 2 weeks prior to first dose of study drug
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) | ||||||
| Official Title ICMJE | Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE) | ||||||
| Brief Summary | Evaluate the activity and safety of oral tofacitinib in adult patients with discoid lupus erythematosus with or without concurrent SLE. | ||||||
| Detailed Description | Discoid Lupus Erythematosus (DLE ) and systemic lupus erythematosus (SLE) can be devastating diseases with a significant impact on quality of life. DLE is currently treated with potent topical steroids, antimalarials, and immunosuppressants. Recent research has determined that DLE is a Th1 mediated disease. There is increasing evidence that JAK inhibitors such as tofacitinib can treat the Th1 mediated diseases such as alopecia areata. Therefore the goal of this study is to determine if JAK inhibitors can successfully treat DLE. Tofacitinib has not previously been studied in DLE. This will be a pilot study that is descriptive for early clinical impressions and molecular mechanisms in order to obtain initial information to potentially design an appropriately -powered phase 2 or 3 study for efficacy of JAK inhibitors that could take place in the future | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Early Phase 1 | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Tofacitinib citrate will be administered twice a day starting on Day 1 at the Baseline Visit. Subjects will take one 5 mg tablet by mouth in the morning and one tablet by mouth in the evening for the 6-month study duration. Masking: None (Open Label)Primary Purpose: Treatment | ||||||
| Condition ICMJE |
| ||||||
| Intervention ICMJE | Biological: Tofacitinib citrate
10 mg daily by mouth Other Name: Xeljanz | ||||||
| Study Arms ICMJE | Experimental: Tofacitinib citrate
All participants will take one 5 mg tablet by mouth in the morning and one tablet by mouth in the evening for the 6-month study duration. Intervention: Biological: Tofacitinib citrate | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Recruiting | ||||||
| Estimated Enrollment ICMJE | 12 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | December 2022 | ||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03159936 | ||||||
| Other Study ID Numbers ICMJE | DLE | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
| ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Tufts Medical Center | ||||||
| Study Sponsor ICMJE | Tufts Medical Center | ||||||
| Collaborators ICMJE | Pfizer | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Tufts Medical Center | ||||||
| Verification Date | August 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||