Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Eryt… (NCT03159936) | Clinical Trial Compass
TerminatedEarly Phase 1
Oral Tofacitinib in Adult Subjects With Discoid Lupus Erythematosus (DLE) and Systemic Lupus Erythematosus (SLE)
Stopped: unable to identify additional subjects to qualify for enrollment
United States5 participantsStarted 2017-04-03
Plain-language summary
Evaluate the activity and safety of oral tofacitinib in adult patients with discoid lupus erythematosus with or without concurrent SLE.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 …
What they're measuring
1
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI)