Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus

Completed · Phase 1

Conditions studied: Cutaneous Lupus

In brief

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.

Key facts

Study ID

NCT05048238

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

7

Starts

2022-09-30

Expected to finish

2024-02-29

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• If taking oral mycophenolate mofetil (MMF) or mycophenolic acid, the dose must be equivalent to ≤ 3000 mg of MMF daily, stable for at least 4 weeks, and not anticipated to change over the course of the study.
• Adults 18 to 65 years of age at screening.
• All participants and/or their sexual partners who engage in sexual activity that could lead to pregnancy must be willing to use complete abstinence or an FDA-regulated form of contraception for the duration of the study and for at least one month after discontinuation of study drug to prevent pregnancy. Highly effective birth control methods include, but are not limited to, hormonal contraception, an intrauterine device, or surgical options. Periodic abstinence and withdrawal are not acceptable methods of birth control.

You may not qualify if…

• 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.
• History of severe gastrointestinal narrowing or strictures.
• Medically confirmed history of diverticulitis or chronic, ulcerative lower gastrointestinal (GI) disease such as Crohn's disease, ulcerative colitis, or other symptomatic, lower GI conditions that might predispose a participant to perforations.
• History of thrombosis, pulmonary embolism, or antiphospholipid syndrome.
• History of any one of the following anti-phospholipid antibodies:
• Positive lupus anticoagulant test, or
• Anti-β2-glycoprotein I IgG ELISA titer ≥ 40 GPL, or
• Anti-cardiolipin IgG ELISA titer ≥ 40 GPL.
• History of chronic pulmonary disease requiring supplemental oxygen including chronic obstructive pulmonary disease (COPD) requiring chronic treatment, interstitial lung disease (ILD) requiring immunosuppressive therapy, and asthma requiring chronic steroid (other than inhaled steroid) or biologic therapy.
• History of moderate to severe atherosclerotic cardiovascular disease as evidenced by prior coronary artery bypass surgery, coronary artery stent placement, myocardial infarction, symptomatic carotid arterial disease, peripheral vascular disease, abdominal aortic aneurysm; or angina within the past 8 weeks prior to Visit 1 (Day 0).
• History of keloid scarring.
• History of any lymphoproliferative disorder or other malignancy with the exception of successfully treated or excised basal cell or squamous cell skin cancer or cervical cancer in situ.
• Other autoimmune diseases likely to require immunosuppression.
• Any of the following lab results at screening:
• Hemoglobin <9.5 g/dL
• White Blood Cell count <3.5 x 109/L
• Absolute Neutrophil count <1.2 x 109/L
• Platelet count <120 x 109/L

Where it is running

• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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