NCT04908280已完成2 期
Exploratory Study of Ruxolitinib Cream for the Treatment of Discoid Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mean Severity of Disease as Measured by the Investigator's Global Assessment
研究概览
简要总结
The purpose of this study is to assess the potential efficacy of topical ruxolitinib for the treatment of discoid lupus erythematosus (DLE)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and comply with the protocol and provide informed consent.
- •Speaks English.
- •Age ≥ 18 years.
- •Clinical diagnosis of discoid lupus as assessed by the PI.
- •At least one active (inflamed) discoid lesion with an IGA score of ≥ 3 and with a diameter ≥ 1cm at screening and baseline. Two lesions with equal scores will be necessary if consenting to pre-and post-treatment biopsies.
- •Maximum body surface area of 20%.
排除标准
- •Unwillingness or inability to complete informed consent process or comply with the study protocol.
- •Pregnant or breast-feeding women, or women planning to become pregnant or breastfeed during the study.
- •History of coagulopathy, pulmonary embolism or deep venous thrombosis.
- •History of cutaneous squamous cell carcinoma localized to the treatment area.
- •Serum creatinine > 1.5 mg/dL, or alanine aminotransferase or aspartate aminotransferase > 1.5 × upper limit of normal.
- •Other dermatologic disease besides discoid lupus whose presence or treatments could complicate assessments.
- •Other diseases besides dermatologic disorders whose treatment could complicate assessments. Subjects with systemic lupus erythematosus are permitted as long as they do not have unstable disease and meet all other criteria, including the exclusion criteria for systemic immunosuppressive or immunomodulating drugs (below).
- •Topical treatments for discoid lupus within 2 weeks of Visit
- •Systemic immunosuppressive or immunomodulating drugs (e.g. oral or injectable corticosteroids, methotrexate, cyclosporine, mycophenolate mofetil, azathioprine) other than antimalarials (hydroxychloroquine, chloroquine, quinacrine) within 4 weeks or 5 half-lives of Visit 2 (whichever is longer).
- •Potent systemic cytochrome P450 3A4 inhibitors or fluconazole within 2 weeks or 5 half-lives, whichever is longer, before Visit 2 (topical agents with limited systemic availability are permitted).
- •Prior use of JAK inhibitors, systemic or topical, within the last 12 months.
- •Ultraviolet (UV) therapy or tanning within 2 weeks prior to Visit 2 or during the duration of the treatment period.
- •Any systemic or local infection that, in the opinion of the investigator, may compromise the safety of the subject or complicate assessments.
- •Subjects allergic to lidocaine or with a history of keloids will not be allowed to provide an optional skin biopsy, but will be eligible for the remainder of the study.
- •Electrocardiogram (ECG) changes on baseline screening consistent with high risk for a major adverse cardiovascular event (MACE).
研究组 & 干预措施
Discoid lupus erythematosus
Experimental
Patients with discoid lupus erythematosus will be given ruxolitinib cream to be used twice daily for 12 weeks.
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
Mean Severity of Disease as Measured by the Investigator's Global Assessment
时间窗: 12 weeks
The Investigator's Global Assessment will be performed at study visits 2-6. The IGA is an instrument to rate the severity of the subject's global disease. This IGA is comprised of a 5-point scale of disease activity ranging from 0 to 4 as follows: 0: "clear," no erythema or scale 1. "almost clear," pink erythema without scale 2. "mild," pink erythema with scale 3. "moderate," red erythema with scale 4. "severe," purple/violaceous or hemorrhagic/crusted erythema OR hypertrophic/ verrucous scale Range of scores are 0-4 with higher scores indicating worse outcome.
次要结局
- Mean Percentage Change in Disease Activity as Measured by the Cutaneous Lupus Area and Severity Index-A (CLASI)(Baseline to 12 weeks)
- Mean Change in Erythema Index Score(Baseline to 12 weeks)
- Mean Change in Itch Symptoms(Baseline to 12 weeks)
- Mean Change in Pain Symptoms(Baseline to 12 weeks)
- Mean Change in Melanin Index Score(Baseline to 12 weeks)
研究者
Christopher T Richardson MD, PhD
Professor
University of Rochester
研究点 (1)
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