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

NCT03159936

Last updated date
Study Location
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Contact
617-636-7462

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Discoid Lupus Erythematosus, Systemic Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Discoid Lupus Erythematosus, Systemic Lupus ErythematosusOral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
NCT03159936
  1. Boston, Massachusetts
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Discoid Lupus Erythematosus
  • Systemic Lupus Erythematosus
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
 (submitted: May 18, 2017)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicole Dumont617-636-7462[email protected]
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
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
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Tufts Medical Center
Study Sponsor  ICMJE Tufts Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:David Rosmarin, MDTufts Medical Center
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