NCT04492683

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: DBV Technologies · Industry
• Sex: All
• Age: 29 Days – 24 Months
• Healthy volunteers: Accepted

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.

Conditions

• Cow's Milk Allergy

Interventions

Type	Name	Description
COMBINATION_PRODUCT	DBV1605	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.

Timeline

• Start date: 2020-08-28
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2020-07-30
• Last updated: 2022-08-11

Locations

33 sites across 4 countries: United States, Canada, Italy, Lithuania

Regulatory

• FDA-regulated drug study