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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

About this trial

This is an interventional treatment trial for Discoid Lupus Erythematosus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

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

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

Learn more about this trial

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

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