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DBV1605 Diagnostic Test for Cow's Milk Allergy (APTITUDE Trial)

Phase 2
Waitlist Available
Research Sponsored by DBV Technologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects aged > 28 days to ≤ 24 months at Screening Visit
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours
Awards & highlights

APTITUDE Trial Summary

This trial is testing a new method for diagnosing non-IgE mediated cow's milk allergy in children with symptoms suggestive of the allergy.

Who is the study for?
This trial is for children aged over 28 days to under 24 months who show signs of non-IgE mediated cow's milk allergy. They must be able to tolerate cow's milk, follow a strict dairy-free diet as per the study, and not have any other type of allergies. Children exclusively breastfed or with ongoing gastrointestinal symptoms cannot participate.Check my eligibility
What is being tested?
The trial is testing DBV1605's ability to accurately diagnose non-IgE mediated cow's milk allergy in young children. It will evaluate how well the test can correctly identify those with and without the condition (sensitivity and specificity).See study design
What are the potential side effects?
The information provided does not specify side effects related to DBV1605; however, since it is a diagnostic tool rather than a medication, significant side effects are less likely compared to therapeutic drugs.

APTITUDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 month and 2 years old.
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I have been consuming cow's milk or started a cow's milk elimination diet less than 4 weeks ago.
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I am a child aged between 1 month and 2 years.
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I am between 1 month and 2 years old.
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I show symptoms that suggest I might have a non-IgE milk allergy.
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I show symptoms that suggest I might have a non-IgE milk allergy.

APTITUDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Diagnostic performance of DBV1605
Secondary outcome measures
Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)

APTITUDE Trial Design

2Treatment groups
Experimental Treatment
Group I: Disease groupExperimental Treatment1 Intervention
One active patch and one control patch applied to subjects with clinical symptoms suggestive of non-IgE mediated CMA
Group II: Control groupExperimental Treatment1 Intervention
One active patch and one control patch applied to subjects without any history of allergic disease

Find a Location

Who is running the clinical trial?

DBV TechnologiesLead Sponsor
16 Previous Clinical Trials
3,292 Total Patients Enrolled

Media Library

DBV1605 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04492683 — Phase 2
Cow's Milk Allergy Research Study Groups: Disease group, Control group
Cow's Milk Allergy Clinical Trial 2023: DBV1605 Highlights & Side Effects. Trial Name: NCT04492683 — Phase 2
DBV1605 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04492683 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to partake in this experiment?

"This clinical study is recruiting a total of 230 infants and toddlers between 29 days to 24 months with cow's milk allergies. Furthermore, they must have been exhibiting symptoms that suggest non-IgE mediated Cow’s Milk Allergy, as well as agree to follow the prescribed diet plan consisting of no use of cow's milk products or other mammalian milks (e.g., sheep and goat). Additionally male or female participants should not have started any sort of dietary regimen containing daily products with cow’s milk protein in the four weeks leading up to screening visit."

Answered by AI

How many individuals are enrolled in this medical trial?

"In order to reach the recruitment target of 230, participants must meet certain criteria. These patients may take part in this trial at Alliance for Multispecialty Research, LLC - New Roy Office (Roy, Utah) or Children's Hospital of Philadelphia (Philadelphia, Pennsylvania)."

Answered by AI

How many health care facilities are presently conducting this research in the state?

"Currently, 24 medical centres are recruiting patients for this trial. These range from the Alliance for Multispecialty Research in Roy to Halton Pediatric Allergy located in Burlington and other locations scattered across America."

Answered by AI

Is this trial actively recruiting participants at this time?

"According to the clinicaltrials.gov portal, this medical experiment is currently searching for volunteers and was first published on August 28th 2020 with its most recent update made two years later on August 9th 2022."

Answered by AI

Is this medical trial enrolling individuals who are younger than sixty years old?

"For this medical study, participants must be between 29 Days and 24 Months of age. Additionally, there are 85 trials for minors and 156 trials available to seniors."

Answered by AI

Has the FDA granted its authorization for DBV1605?

"DBV1605 has been assigned a safety score of 2, as prior clinical data exists to support its safety but no efficacy results have yet been obtained."

Answered by AI

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Sunshine Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~50 spots leftby Mar 2025