Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children (APTITUDE)
Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children (APTITUDE)
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 230 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date: August 28, 2020
Estimated Primary Completion Date: June 2021
Estimated Study Completion Date: June 2021
Arm:
- Experimental: Disease group
- Experimental: Control group
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 230 |
| Actual Study start date | 28 August 2020 |
| Estimated Study Completion Date | 01 June 2021 |