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

DBV Technologies33 sites in 4 countries230 target enrollmentAugust 28, 2020

ConditionsCow's Milk Allergy

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cow's Milk Allergy
Sponsor: DBV Technologies
Enrollment: 230
Locations: 33
Primary Endpoint: Diagnostic performance of DBV1605
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 28, 2020

End Date

March 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

DBV Technologies

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diagnostic performance of DBV1605

Time Frame: 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.