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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04492683
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : August 11, 2022
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cow's Milk Allergy Combination Product: DBV1605 Phase 2

Study Design
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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 : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Disease group
One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA
 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.
Experimental: Control group
One active patch and one control patch applied to subjects without any history of allergic disease
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic performance of DBV1605 [ Time Frame: 48 hours ]
    Sensitivity and specificity of DBV1605 based on skin reactivity readings after 48 hours will be compared to the results of the DBPCFC in subjects of the disease group.

  2. 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.


Secondary Outcome Measures :
  1. Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) [ Time Frame: Up to day 49 ]

Eligibility Criteria
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Ages Eligible for Study:   29 Days to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE GROUP

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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492683


Locations
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Sponsors and Collaborators
DBV Technologies
More Information
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Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT04492683    
Other Study ID Numbers: V1605-201
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DBV Technologies:
Non-IgE mediated CMA
Additional relevant MeSH terms:
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Hypersensitivity
Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate