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

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ClinicalTrials.gov Identifier: NCT03159936
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : May 19, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Tufts Medical Center

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
Discoid Lupus Erythematosus Systemic Lupus Erythematosus 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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
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 : April 3, 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : April 2019


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 Name: Xeljanz




Primary Outcome Measures :
  1. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) [ Time Frame: week 24 ]
    Percent change



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159936


Contacts
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Contact: Nicole Dumont 617-636-7462 ndonovan1@tuftsmedicalcenter.org

Locations
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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Nicole Dumont    617-636-7462    ndonovan1@tuftsmedicalcenter.org   
Sponsors and Collaborators
Tufts Medical Center
Pfizer
Investigators
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Principal Investigator: David Rosmarin, MD Tufts Medical Center

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03159936     History of Changes
Other Study ID Numbers: DLE
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Discoid
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Citric Acid
Sodium Citrate
Tofacitinib
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors