Cow's Milk Allergy
Conditions
Keywords
Non-IgE mediated CMA
Brief summary
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.
Interventions
COMBINATION_PRODUCTDBV1605
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.
Sponsors
DBV Technologies
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
29 Days to 24 Months
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of DBV1605 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) | Up to day 49 |
Countries
Canada, Italy, Lithuania, United States
Outcome results
None listed