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Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)

Sponsor
Tufts Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT03159936
Collaborator
Pfizer (Industry)
5
Enrollment
1
Location
1
Arm
38.2
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the activity and safety of oral tofacitinib in adult patients with discoid lupus erythematosus with or without concurrent SLE.

Condition or Disease Intervention/Treatment Phase
  • Biological: Tofacitinib citrate
 Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
5 participants
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.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
Official Title:
Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
Actual Study Start Date :
Apr 3, 2017
Actual Primary Completion Date :
May 13, 2020
Actual Study Completion Date :
Jun 10, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

Biological: Tofacitinib citrate
10 mg daily by mouth
Other Names:
  • Xeljanz

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) [week 24]

      Percent change

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tufts Medical Center Boston Massachusetts United States 02111

    Sponsors and Collaborators

    • Tufts Medical Center
    • Pfizer

    Investigators

    • Principal Investigator: David Rosmarin, MD, Tufts Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tufts Medical Center
    ClinicalTrials.gov Identifier:
    NCT03159936
    Other Study ID Numbers:
    • DLE
    First Posted:
    May 19, 2017
    Last Update Posted:
    Jan 21, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Lupus Erythematosus, Systemic
    Lupus Erythematosus, Discoid
    Tofacitinib

    Study Results

    No Results Posted as of Jan 21, 2022