Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children
- Conditions
- Cow's Milk Allergy
- Interventions
- Combination Product: DBV1605
- Registration Number
- NCT04492683
- Lead Sponsor
- DBV Technologies
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 230
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Disease group DBV1605 One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA Control group DBV1605 One active patch and one control patch applied to subjects without any history of allergic disease
- Primary Outcome Measures
Name Time Method Diagnostic performance of DBV1605 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.
- Secondary Outcome Measures
Name Time Method Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) Up to day 49
Trial Locations
- Locations (33)
Titan Clinical Research
🇺🇸Phoenix, Arizona, United States
University of Arizona Health Science
🇺🇸Tucson, Arizona, United States
University of California, Rady Children's Hospital
🇺🇸San Diego, California, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Eastern Research Inc.
🇺🇸Hialeah, Florida, United States
Biomedical Research, LLC
🇺🇸Miami, Florida, United States
Sunshine Research Center
🇺🇸Opa-locka, Florida, United States
Allergy Center at Brookstone - Research Department
🇺🇸Columbus, Georgia, United States
MedPharmics, LLC - Lafayette
🇺🇸Lafayette, Louisiana, United States
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