NCT04492683Unknown2 期
A Phase 2 Study to Evaluate the Sensitivity, Specificity and Safety of DBV1605, a Ready-to-Use Atopy Patch Test for the Diagnosis of Non-Immunoglobulin E Mediated Cow's Milk Allergy in Children
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 230
- 试验地点
- 33
- 主要终点
- Diagnostic performance of DBV1605
研究概览
简要总结
Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 29 Days 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DISEASE GROUP
- •Inclusion Criteria:
- •Male or female subjects aged > 28 days to ≤ 24 months at Screening Visit
- •Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy
- •Subjects with any type of diet containing daily products with cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) prior to Screening Visit or who have started a cow's milk elimination diet not more than 4 weeks prior to Screening Visit,
- •Subjects/parents/guardians who agree to follow a strict cow's milk-free diet and other mammalian milks (such as sheep and goat's milk) as per study requirements.
排除标准
- •Subjects with an established diagnosis of non-IgE mediated CMA
- •Breast-fed subject at Screening Visit
- •Subjects with a convincing history of IgE-mediated CMA
- •Subjects on a cow's milk protein-free diet including an AA-based formula or an extensively hydrolyzed formula initiated more than 4 weeks prior to Screening Visit.
- •Generalized dermatologic disease (e.g. severe atopic dermatitis, ) extending widely on the skin.
- •Any contraindication to a cow's milk challenge
- •CONTROL GROUP
- •Inclusion Criteria:
- •Male or female subjects aged > 28 days to ≤ 24 months at Screening visit
- •Subjects having no medical history of any type of allergy
- •Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods daily within 4 weeks prior to Screening visit
- •Exclusion Criteria:
- •Subjects with history of persistent gastro-intestinal symptoms
- •Exclusively breast-fed subjects at Screening visit
研究组 & 干预措施
Control group
Experimental
One active patch and one control patch applied to subjects without any history of allergic disease
干预措施: DBV1605 (Combination Product)
Disease group
Experimental
One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA
干预措施: DBV1605 (Combination Product)
结局指标
主要结局
Diagnostic performance of DBV1605
时间窗: 72 hours
Sensitivity and specificity of DBV1605 based on skin reactivity readings after 72 hours will be compared to the results of the DBPCFC in subjects of the disease group.
Diagnostic performance of DBV1605
时间窗: 48 hours
Sensitivity and specificity of DBV1605 based on skin reactivity readings after 48 hours will be compared to the results of the DBPCFC in subjects of the disease group.
次要结局
- Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)(Up to day 49)
研究者
研究点 (33)
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