Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cow's Milk Allergy

Intervention / Treatment
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* Combination Product: DBV1605


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Disease group<br>One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA | Combination Product: DBV1605<br>* Ready-to-use atopy patch test for diagnostic use containing 2 distinct patches: One active patch containing a dry deposit of 180 μg of cow's milk proteins One control patch with the same design as the active patch but devoid of any formulation.<br>|
| Experimental: Control group<br>One active patch and one control patch applied to subjects without any history of allergic disease | Combination Product: DBV1605<br>* Ready-to-use atopy patch test for diagnostic use containing 2 distinct patches: One active patch containing a dry deposit of 180 μg of cow's milk proteins One control patch with the same design as the active patch but devoid of any formulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of DBV1605 | 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. | 48 hours | 
| Diagnostic performance of DBV1605 | 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. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) |  | Up to day 49 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-IgE mediated CMA