The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction

University of Michigan1 个研究点分布在 1 个国家目标入组 10 人2023年10月2日

适应症Dermal Hypersensitivity Reaction

干预措施Dupilumab

概览

阶段: 4 期
干预措施: Dupilumab
疾病 / 适应症: Dermal Hypersensitivity Reaction
发起方: University of Michigan
入组人数: 10
试验地点: 1
主要终点: Change in Th2 immune cell population in lesional Dermal hypersensitivity reaction (DHR) skin at week 16 compared to week 0.
状态: 已完成
最后更新: 3个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This research is studying a drug called dupilumab to learn about its safety and its effect as a treatment for participants with dermal hypersensitivity reaction. This study will help better understand why and how dermal hypersensitivity reaction occurs and how dupilumab might help treat this condition.

详细描述

Dermal hypersensitivity reaction is a skin rash that can happen as a reaction to a known trigger or it can happen for unknown reasons. Not a lot is known about why the rash occurs and what happens to the immune system to cause this rash. Dupilumab, a biologic drug that is given as an injection under the skin, may treat dermal hypersensitivity reaction. This study tries to better understand dermal hypersensitivity reaction and how the immune system responds to dupilumab.

注册库

clinicaltrials.gov

开始日期

2023年10月2日

结束日期

2025年3月25日

最后更新

3个月前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

University of Michigan

责任方

Principal Investigator

主要研究者

Mio Nakamura

Assistant Professor of Dermatology

University of Michigan

入排标准

入选标准

•Established diagnosis of chronic idiopathic DHR as defined by presence of clinical and histopathologic features of DHR for at least 6 weeks without an underlying cause or associated trigger
•Moderate-to-severe DHR as defined by greater or equal 5% total body-surface-area (TBSA) involvement and IGA of greater or equal to
•Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for 12 weeks after the last study drug injection, when this is in line with the preferred and usual lifestyle of the subject, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.
•Subject willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol.

排除标准

•Subjects meeting 1 or more of the following criteria at screening or baseline:
•Had an exacerbation of asthma requiring hospitalization in the preceding 12 months.
•Reporting asthma that has not been well-controlled (ie, symptoms occurring on \>2 days per week, nighttime awakenings 2 or more times per week, or some interference with normal activities) during the preceding 3 months.
•Subjects with a current medical history of chronic obstructive pulmonary disease and/or chronic bronchitis.
•Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
•Confirmed or suspected COVID-19 infection within 4 weeks before the screening or baseline visit.
•Previous treatment with dupilumab.
•Pregnant women (positive urine pregnancy test result at the screening visit or the baseline visit), breastfeeding women, or women planning a pregnancy during the clinical study.
•History of, current, or suspected lymphoproliferative disease or malignancy of any organ system within the last 5 years, except for basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no evidence of recurrence in the last 12 weeks before the baseline visit.
•History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, i.e., monoclonal antibody) or to lidocaine.

研究组 & 干预措施

Dupilumab

All patients will receive dupilumab.

干预措施: Dupilumab

结局指标

主要结局

Change in Th2 immune cell population in lesional Dermal hypersensitivity reaction (DHR) skin at week 16 compared to week 0.

时间窗: Week 0, week 16

次要结局

Changes in Investigator Global Assessment (IGA) in patients with DHR treated with dupilumab at week 2 from week 0.(Week 0, 2 weeks)
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 2 from week 0.(Week 0, 2 weeks)
Changes in Total Body surface area in patients with DHR treated with dupilumab at week 8 from week 0.(Week 0, week 8)
Changes in Total Body surface area in patients with DHR treated with dupilumab at week 24 from week 0.(Week 0, week 24)
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 8 from week 0.(Week 0, 8 weeks)
Changes in Total Body surface area (TBSA) in patients with DHR treated with dupilumab at week 2 from week 0.(Week 0, week 2)
Changes in Total Body surface area in patients with DHR treated with dupilumab at week 16 from week 0.(Week 0, week 16)
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 16 from week 0.(Week 0, 16 weeks)
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 8 from week 0.(Week 0, 8 weeks)
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 16 from week 0.(Week 0, 16 weeks)
Changes in Pruritus Numeric Rating Scale (NRS) for average itch intensity at week 24 from week 0.(Week 0, 24 weeks)
Changes in Investigator Global Assessment in patients with DHR treated with dupilumab at week 24 from week 0.(Week 0, 24weeks)
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 2 from week 0.(Week 0, 2 weeks)
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 8 from week 0.(Week 0, 8 weeks)
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 16 from week 0.(Week 0, 16 weeks)
Changes in Pruritus Numeric Rating Scale (NRS) for maximum itch intensity 24 from week 0.(Week 0, 24 weeks)