What side effects are associated with this type of intervention?

Common treatments for Cow's Milk Allergy (CMA), especially non-IgE mediated CMA, include hypoallergenic formulas like extensively hydrolyzed formulas and amino acid-based formulas. These treatments are generally well-tolerated but can be more expensive. Oral immunotherapy (OIT) and sublingual immunotherapy (SLIT) are also explored for CMA. OIT can lead to serious allergic reactions, including anaphylaxis, requiring treatment with epinephrine. SLIT is generally safer but can cause local reactions such as itching and swelling in the mouth. Both treatments require careful medical supervision.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for non-IgE mediated Cow's Milk Allergy (CMA). Most treatments for CMA focus on dietary management, such as the use of extensively hydrolyzed formulas or amino acid-based formulas for infants. For IgE-mediated CMA, avoidance of cow's milk and the use of epinephrine for severe allergic reactions are standard. DBV1605 is being studied as a diagnostic tool for non-IgE mediated CMA, but it is not yet approved. Overall, the management of CMA primarily involves dietary modifications rather than pharmacological treatments.

What other types of research exist?

Promising alternatives to DBV1605 for diagnosing or treating non-IgE mediated cow's milk allergy in 2024 include: 1) Basophil Activation Test (BAT), which has shown potential in reducing the need for oral food challenges; 2) Probiotic and peanut oral immunotherapy (PPOIT), which has demonstrated success in desensitizing patients to allergens and could be adapted for cow's milk; 3) Combined treatment with anti-IgE (omalizumab) and specific food allergen immunotherapy, which has been effective in rapid desensitization and reducing severe allergic reactions in other food allergies.

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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

Male or female subjects aged > 28 days to ≤ 24 months at Screening visit

Must not have

Subjects with history of persistent gastro-intestinal symptoms

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Summary

This trial is testing DBV1605, a tool to diagnose cow's milk allergy in children who do not have the usual IgE-related symptoms. It aims to see how well DBV1605 can identify this specific type of 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.

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).

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.

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 am a child aged between 1 month and 2 years.

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I show symptoms that suggest I might have a non-IgE milk allergy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have ongoing stomach or intestinal problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Diagnostic performance of DBV1605

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cow's Milk Allergy (CMA) include elimination diets, extensively hydrolyzed formulas, and amino acid-based formulas. For non-IgE mediated CMA, elimination of cow's milk proteins from the diet is crucial, as these proteins trigger immune responses in sensitive individuals. Extensively hydrolyzed formulas break down milk proteins into smaller peptides, reducing allergenicity, while amino acid-based formulas provide nutrition without any intact proteins, thus avoiding immune reactions. Understanding these mechanisms is vital for patients to manage symptoms effectively and prevent adverse reactions, ensuring proper growth and development in children with CMA.

Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long-term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis.Omalizumab in children.Accelerated immunotherapy schedules.