Effectiveness of Dupilumab in Food Allergic Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- UMC Utrecht
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Dupilumab on change in clinical eliciting dose (i.e. lowest dose causing an allergic reaction) in subjects with peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy
研究概览
简要总结
This study evaluates the effectiveness of Dupilumab in food allergic patients with moderate to severe Atopic Dermatitis (AD). Included patients participated in the BioDay Registry.
详细描述
The positive results of the dupilumab studies in AD, asthma and nasal polyposis with chronic sinusitis validate the fundamental role for IL-4 and IL-13 in the pathogenesis of these diseases, and add to the possibility that these cytokines are also critically involved in other related allergic/atopic (type 2 immune) diseases that are often co-morbidly associated with AD, such as food allergy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AD patients with moderate to severe AD who are indicated for treatment with dupilumab
- •Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy allergic subjects, with a well-documented medical history of reactions after ingestion.Peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy specific immunoglobulin E (IgE) level (Phadia CAP-system) higher than 0.35 kU/L or a skin prick test of at least 3 mm
- •Positive double-blind placebo-controlled Food Challenge (DBPCFC) with an eliciting dose before the last dose
- •Signed Bioday informed consent from subjects
排除标准
- •Subjects reacting objectively to the placebo at screening.
- •Subjects in whom DBCPFC is contra-indicated or in whom DBPCFC is not reliable
结局指标
主要结局
To evaluate the effect of Dupilumab on change in clinical eliciting dose (i.e. lowest dose causing an allergic reaction) in subjects with peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy
时间窗: Each subject will undergo two oral food challenges: one at screening and one during dupilumab treatment with a treatment duration of at least 28 weeks.
AD patients with moderate to severe AD who are indicated for treatment with dupilumab and have symptomatic food allergy to peanut, hazelnut, walnut, cow's milk, hen's egg and/or soybean allergy will be included.
次要结局
- To evaluate the effect of Dupilumab on the level of specific IgE (sIgE) antibodies(sIgE in blood will be measured every three months during dupilumab treatment)
- To evaluate the effect of Dupilumab on food allergy related quality of life(Before the first food challenge and 3 months after the second food challenge during their visit conform Bioday protocol.)
- To evaluate the effect of Dupilumab on the biological activity of IgE for peanut and hazelnut and measurement of biomarkers profile(The basophil activation test and the measurement of biomarkers on Luminex at baseline and after at least 28 weeks of dupilumab treatment (e.g. at time of second challenge))
研究者
Dr M.S. de Bruin-Weller
Principal Investigator
UMC Utrecht