Summary

Eligibility
for people ages 1 month to 5 years (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Diego, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Stephanie Leonard, MD

Description

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.

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

Keywords

Cow's Milk Allergy Non-IgE mediated CMA Hypersensitivity Milk Hypersensitivity DBV1605

Eligibility

For people ages 1 month to 5 years

DISEASE GROUP

Inclusion Criteria:

  • Male or female subjects aged 1 month to 5 years at Screening Visit
  • Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy
  • Subjects with any type of diet containing regular cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) within 1 month 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 within 1 month of 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 1 month to 5 years 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 1 month prior to Screening visit

Exclusion Criteria:

  • Subjects with history of persistent gastro-intestinal symptoms
  • Breast-fed subjects

Locations

  • University of California, Rady Children's Hospital not yet accepting patients
    San Diego California 92123 United States
  • Titan Clinical Research accepting new patients
    Phoenix Arizona 85004 United States

Lead Scientist at UCSD

  • Stephanie Leonard, MD
    Associate Clinical Professor, Pediatrics. Authored (or co-authored) 16 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
DBV Technologies
ID
NCT04492683
Phase
Phase 2
Study Type
Interventional
Last Updated