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

DBV Technologies

Status and phase: Unknown; Phase 2

Conditions: Cow's Milk Allergy

Treatments: Combination Product: DBV1605

Study type: Interventional

Funder types: Industry

Identifiers

NCT04492683

V1605-201

Details and patient eligibility

About

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.

Enrollment: 230 estimated patients

Sex: All

Ages: 29 days to 24 months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

• Subjects with history of persistent gastro-intestinal symptoms
• Exclusively breast-fed subjects at Screening visit

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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230 participants in 2 patient groups

Disease group

Experimental group

Description:

One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA

Treatment:

Combination Product: DBV1605

Control group

Experimental group

Description:

One active patch and one control patch applied to subjects without any history of allergic disease

Treatment:

Combination Product: DBV1605