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

NCT03159936 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: DLE
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Discoid Lupus Erythematosus; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)

  Percent change

  week 24

Study Arms (1)

Tofacitinib citrate

EXPERIMENTAL

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

Interventions

Tofacitinib citrate BIOLOGICAL

10 mg daily by mouth

Also known as: Xeljanz

Tofacitinib citrate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• Pfizer: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Discoid; Lupus Erythematosus, Systemic

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Lupus Erythematosus, Cutaneous; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• David Rosmarin, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 19, 2017
• Study Start: April 3, 2017
• Primary Completion: May 13, 2020
• Study Completion: June 10, 2020
• Last Updated: January 21, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)