Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
Primary Purpose
Discoid Lupus Erythematosus, Systemic Lupus Erythematosus
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tofacitinib citrate
Sponsored by
About this trial
This is an interventional treatment trial for Discoid Lupus Erythematosus
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Sites / Locations
- Tufts Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tofacitinib citrate
Arm Description
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.
Outcomes
Primary Outcome Measures
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Percent change
Secondary Outcome Measures
Full Information
NCT ID
NCT03159936
First Posted
May 2, 2017
Last Updated
January 6, 2022
Sponsor
Tufts Medical Center
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT03159936
Brief Title
Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
Official Title
Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
unable to identify additional subjects to qualify for enrollment
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
May 13, 2020 (Actual)
Study Completion Date
June 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discoid Lupus Erythematosus, Systemic Lupus Erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tofacitinib citrate
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
Tofacitinib citrate
Other Intervention Name(s)
Xeljanz
Intervention Description
10 mg daily by mouth
Primary Outcome Measure Information:
Title
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)
Description
Percent change
Time Frame
week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Rosmarin, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
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