NCT03935971进行中（未招募）4 期
The Effects of Dupilumab on Allergic Contact Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in Investigator's Global Assessment (IGA) score
研究概览
简要总结
The aim of this study is to investigate the effects of dupilumab on allergic contact dermatitis.
详细描述
The investigators will recruit 30 patients with allergic contact dermatitis who have not improved with allergen avoidance up to 18 months after patch testing, but where allergic contact dermatitis is still suspected. Subjects will receive 10 weeks of dupilumab, and both clinical data and tissue samples will be assessed.
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
- •At least 18 years of age
- •At least one contact allergen with a 2+ (strong) or 3+ (extreme reaction) confirmed by patch testing within 6 months of the baseline visit that can be duplicated at the initiation of the study (placement at Week 0 and patch test reaction read at Week 0 +72-120 hours).
- •Allergic contact dermatitis diagnosed clinically by the principle investigators who have expertise in allergic contact dermatitis
- •Investigator's global assessment score of at least 3 (range 0-4) at the screening and baseline visits
- •Documented recent history (within 18 months of patch testing) of inadequate response to treatment with topical medications and allergen avoidance
- •Able and willing to provide informed consent, participate in study visits, and undergo visit procedures
排除标准
- •Prior dupilumab use
- •Treatment with a systemic immune-regulating medication within 3 months of the baseline visit or the patient's prior patch testing, whichever is longer. Examples of these medications include azathioprine, methotrexate, mycophenolate mofetil, Janus kinase inhibitors, and phototherapy (including tanning booths). Cyclosporine or prednisone may not have been used within 1 month of the baseline visit.
- •Treatment with other biologic agents, such as TNF inhibitors, anti-IL 17 agents, anti-IL 12/23 agents, or anti-IL 23 agents, within 4 months of baseline visit or the patient's prior patch testing, whichever is longer.
- •Use of rituximab within at 6 months (or until lymphocyte counts have normalized if longer than 6 months) of the baseline visit or the patient's prior patch testing, whichever is longer.
- •Treatment with topical corticosteroids or topical calcineurin inhibitors within 1 week before the baseline visit
- •Other active conditions, such as psoriasis, that may confound clinical evaluations of dermatitis and patient-reported symptoms
- •Increased risk of infection or reactivated infection, including history of human immunodeficiency virus, hepatitis B, hepatitis C, endoparasitic infections, receipt of a live attenuated vaccine within 3 months of the baseline visit, chronic or acute infection requiring treatment within 4 weeks of the baseline visit, immunosuppressed status (ie recurrent or resistant opportunistic infections)
- •Malignancy within 5 years of the screening visit excluding local cutaneous squamous cell carcinoma, basal cell carcinoma or cervical carcinoma in situ that has been fully treated.
- •Women who are or plan to become pregnant or breastfeed during study participation or are unable or not willing to use birth control during the study and for 4 months after the last dose of dupilumab. Options for birth control include abstinence, double barrier (ie male condom and female diaphragm), vasectomy, intrauterine device, and hormonal contraception. Females who have not had menses within 1 year of the baseline, bilateral tubal ligation, hysterectomy, and/or bilateral oophorectomy visit do not require additional methods contraception during study participation.
- •Unstable condition or status, as per study investigator's judgment, that may lead to more likely discontinuation from the study including but not limited to major, recurrent medical illnesses that may require hospital admission and/or discontinuation of dupilumab, surgery that would require discontinuation of dupilumab and/or major rehabilitation, inability to participate in all study visits and administer dupilumab
- •Resident outside of Massachusetts, Connecticut, Rhode Island, New Hampshire, Maine or Vermont state.
- •Unable to use Zoom videoconferencing.
研究组 & 干预措施
Subjects with Allergic Contact Dermatitis
Experimental
Dupilumab 600 mg/4 mL subcutaneously once, then 300 mg/2 mL every 2 weeks for 10 weeks
干预措施: Dupilumab (Drug)
结局指标
主要结局
Change in Investigator's Global Assessment (IGA) score
时间窗: week 0, week 6, week 12
The investigator's global assessment is a physician-reported global assessment of disease activity (range 0-4) with 0 being clear and 4 being severe
Change From Baseline in Investigator's Global Assessment (IGA) Score
时间窗: week 0, week 6, week 12
The investigator's global assessment is a physician-reported global assessment of disease activity (range 0-4) with 0 being clear and 4 being severe.
次要结局
- Change in Body Surface Area (BSA)(week 0, week 6, week 12)
- Change in Eczema Area and Severity Index (EASI) score(week 0, week 6, week 12)
- Change in Numerical Rating Scale (NRS) itch(week 0, week 6, week 12)
- Change in Dermatology Life Quality Index (DLQI)(week 0, week 6, week 12)
- Change in SLEEPY-Q (Sleep Questionnaire) score(week 0, week 6, week 12)
- Blood Samples(week 0, week0+72-120 hours, week 12 and week 12+72-120 hours)
- Skin Samples(week0+72-120 hours and week 12+72-120 hours)
- Change in Eczema Area and Severity Index (EASI) Score(week 0, week 6, week 12)
- Change in Numerical Rating Scale (NRS) Itch(week 0, week 6, week 12)
- Change in SLEEPY-Q (Sleep Questionnaire) Score(week 0, week 6, week 12)
研究者
Ari Goldminz
Instructor
Brigham and Women's Hospital
研究点 (2)
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