CompletedPhase 1

Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus

United States7 participantsStarted 2022-09-30

Plain-language summary

This is a single-arm, multi-site, proof-of-concept study that will evaluate the treatment of 10 participants with cutaneous lupus erythematosus (CLE) with Tofacitinib.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Cutaneous lupus erythematosus based upon all of the following:
✓. a clinical diagnosis made by a rheumatologist or dermatologist of one of the following: acute cutaneous lupus erythematosus, subacute cutaneous lupus, or chronic cutaneous lupus erythematosus;
✓. active skin disease within 5 years prior to screening. Participants may have concomitant SLE.
✓. SLEDAI-2K score ≤4 (clinical criteria only, excludes all laboratory criteria) for all participants regardless of whether they have concomitant SLE.
✓. If taking oral corticosteroids, the dose must be ≤ 10 mg daily of prednisone (or equivalent), stable dose for at least 4 weeks, and not anticipated to change over the course of the study.
✓. If taking oral anti-malarial medications, the dose(s) must be ≤ 100 mg daily for quinacrine or/and ≤ 400 mg daily for hydroxychloroquine, stable for at least 6 months, and not anticipated to change over the course of the study.
✓. If taking oral or subcutaneous methotrexate, the dose must be ≤ 25 mg weekly, stable for at least 4 weeks, and not anticipated to change over the course of the study.
✓. If taking oral leflunomide, the dose must be ≤ 20 mg daily, stable for at least 4 weeks, and not anticipated to change over the course of the study.

Exclusion criteria

✕. Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
✕. Current or recent history, within the last year, of uncontrolled clinically significant renal, hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurologic disease or significant impairment that might negatively impact the participant's ability to participate or that may put a participant at increased risk.
✕. Potential active nephritis and/or urinary tract infection at screening, defined as any one of the following determined at screening unless otherwise specified:
✕. \>10 RBCs /hpf,
✕. \>5 WBCs /hpf with either positive nitrites or greater than a trace leukocyte esterase,
✕. Signs or symptoms of a urinary tract infection,
✕. For individuals with no history of nephritis: Urine protein (mg/dL): creatinine (mg/dL) ratio (Pr/Cr)\>0.5 at screening or a Pr/Cr level that has exceeded 1.0 in the prior 12 months,
✕. For individuals with a history of nephritis: A rise in Pr/Cr of \>0.5 over the prior 3-6 months prior to screening.

What they're measuring

Change in Percentage of UVB-induced Apoptotic Epidermal Cells

Timeframe: Day 1 (pre-treatment) to Day 26

Trial details

NCT IDNCT05048238

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2024-02-15

Results submitted2025-01-29

View on ClinicalTrials.gov More Cutaneous Lupus trials