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

Open Label Phase 2 Pilot Trial of Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)

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

Study Overview

• Status: Terminated
• Conditions: Systemic Lupus Erythematosus; Discoid Lupus Erythematosus
• Intervention / Treatment: Biological: Tofacitinib citrate

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: Interventional
• Enrollment (Actual): 5
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)	Percent change	week 24

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: Pfizer
• Investigators: Principal Investigator: David Rosmarin, MD, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): May 13, 2020
• Study Completion (Actual): June 10, 2020

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): January 21, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: DLE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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