NCT06012448已完成4 期
The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity Reaction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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.
研究概览
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.
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
- •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.
- •Known active or latent tuberculosis (TB) infection.
- •Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.
- •History of or current confounding skin condition (i.e., active atopic dermatitis, chronic urticaria, psoriasis, cutaneous T-cell lymphoma [mycosis fungoides or Sezary syndrome], contact dermatitis, chronic actinic dermatitis, dermatitis herpetiformis).
- •Planned or expected major surgical procedure during the clinical study.
- •Currently participating or participated in any other study of a drug or device, within the past 8 weeks before the screening visit, or is in an exclusion period (if verifiable) from a previous study.
- •History of alcohol or substance abuse within 6 months of the screening.
- •History of poor wound healing or keloid formation.
研究组 & 干预措施
Dupilumab
Experimental
All patients will receive dupilumab.
干预措施: Dupilumab (Drug)
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)
研究者
Mio Nakamura
Assistant Professor of Dermatology
University of Michigan
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Dupilumab As An Adjunct For Subcutaneous Grass ImmunotherapyAllergic RhinitisNCT03558997Regeneron Pharmaceuticals103
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous PemphigoidBullous PemphigoidNCT04206553Regeneron Pharmaceuticals106
已完成
4 期
Immunogenetic Profiling of Dupilumab for the Treatment of Atopic DermatitisAtopic Dermatitis EczemaEczemaAtopic Dermatitis and Related ConditionsAtopic DermatitisNCT03293030University of California, San Francisco17
已完成
3 期
Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE)Eosinophilic Esophagitis (EoE)NCT04394351Regeneron Pharmaceuticals102
已完成
1 期
Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)Atopic DermatitisNCT02647086Regeneron Pharmaceuticals14