Study on the Effectiveness and Safety of DBV712 for Peanut Allergy in Children Aged 4-7

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What is this study about?

This clinical trial is focused on studying a treatment for children aged 4 to 7 years who have a peanut allergy. The treatment being tested is called Viaskin Peanut, also known by its code name DBV712. It is a small patch that is placed on the skin to help the body become less sensitive to peanuts over time. The purpose of the study is to see if this treatment can safely help children with peanut allergies become less sensitive to peanuts.

During the study, children will wear the Viaskin Peanut patch for a period of 12 months. The study will compare the effects of the patch to a placebo, which looks like the patch but does not contain any peanut proteins. The children will be monitored to see if they can tolerate more peanuts after the treatment than they could before. The study will also check for any side effects or reactions to the treatment.

In addition to the Viaskin Peanut patch, the study will use other products to help measure the children’s reactions to peanuts. These include a solution for skin-prick tests and a peanut challenge meal, which are used to test how sensitive the children are to peanuts. The study aims to provide valuable information on the safety and effectiveness of the Viaskin Peanut treatment for children with peanut allergies.

1 initial visit

Upon joining the study, the first step involves an initial visit. During this visit, eligibility is confirmed based on specific criteria, such as age and a documented peanut allergy.

A skin-prick test is conducted to assess the reaction to peanuts. This involves applying a small amount of peanut extract to the skin and observing any reaction.

2 treatment period

The treatment period lasts for 12 months. During this time, the **DBV712 250 microgram** patch is applied daily. This patch is designed to help the body become less sensitive to peanuts.

The patch is applied to the skin, and it is important to follow the instructions for its use carefully. Regular check-ups are scheduled to monitor progress and any side effects.

3 monthly check-ups

Monthly check-ups are conducted to monitor the body’s response to the treatment. These visits include physical examinations and discussions about any side effects experienced.

The effectiveness of the treatment is assessed, and adjustments may be made if necessary.

4 final assessment

At the end of the 12-month treatment period, a final assessment is conducted. This includes a food challenge to determine the level of desensitization achieved.

The results of the study are discussed, and any further recommendations are provided.

Who Can Join the Study?

Children aged 4 through 7 years at the first visit (screening).
Must have a peanut allergy diagnosed by a doctor or a well-documented history of allergic reactions to peanuts.
Currently following a strict diet that does not include peanuts.
Must have access to emergency medications, including self-injectable epinephrine (a medicine used to treat severe allergic reactions), and have a current food allergy emergency action plan.
Must have documentation showing a peanut-specific IgE level greater than 0.7 kUA/L (a blood test that measures allergy antibodies) and a positive peanut SPT (skin prick test) with a wheal (raised bump) size of 6 mm or more within the past 6 months, including during screening.
Signed informed consent from a legally authorized representative and signed assent from children aged 7 years (or as required by local regulations).
Subjects and their parents/caregivers must be willing to comply with all study requirements during participation.
An ED (eliciting dose) of 100 mg or less of peanut protein at the screening Double-blind, Placebo-controlled Food Challenge (DBPCFC), which is a test to confirm the peanut allergy.

Who Cannot Join the Study?

Children who do not have a peanut allergy cannot participate. A peanut allergy is when the body reacts badly to peanuts, causing symptoms like itching or swelling.
Children who are not between the ages of 4 and 7 years old cannot participate.
Children who have other serious health conditions that might interfere with the study cannot participate.
Children who are taking certain medications that might affect the study cannot participate.
Children who have participated in another clinical trial recently cannot participate.
Children who have had a severe allergic reaction to peanuts that required emergency treatment recently cannot participate.
Children who have a condition that affects their immune system, which helps the body fight infections, cannot participate.
Children who have a condition that affects their skin, like severe eczema, cannot participate.
Children who have a condition that affects their breathing, like severe asthma, cannot participate.
Children who have a condition that affects their heart cannot participate.
Children who have a condition that affects their digestive system, like severe stomach problems, cannot participate.
Children who have a condition that affects their nervous system, like seizures, cannot participate.
Children who have a condition that affects their blood, like bleeding disorders, cannot participate.
Children who have a condition that affects their kidneys or liver cannot participate.
Children who have a condition that affects their growth cannot participate.
Children who have a condition that affects their development cannot participate.
Children who have a condition that affects their mental health cannot participate.
Children who have a condition that affects their ability to understand or follow instructions cannot participate.
Children who have a condition that affects their ability to communicate cannot participate.
Children who have a condition that affects their ability to eat or swallow cannot participate.
Children who have a condition that affects their ability to move or walk cannot participate.
Children who have a condition that affects their ability to see or hear cannot participate.
Children who have a condition that affects their ability to sleep cannot participate.
Children who have a condition that affects their ability to breathe cannot participate.
Children who have a condition that affects their ability to learn cannot participate.
Children who have a condition that affects their ability to play cannot participate.
Children who have a condition that affects their ability to socialize cannot participate.
Children who have a condition that affects their ability to participate in activities cannot participate.
Children who have a condition that affects their ability to attend school cannot participate.
Children who have a condition that affects their ability to enjoy life cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Universitair Medisch Centrum Utrecht	Utrecht	The Netherlands
Les Hopitaux Universitaires De Strasbourg	STRASBOURG, Alsace	France
Universitaetsklinikum Ulm AöR	Ulm	Germany
Hospices Civils De Lyon	Lyon	France
Evangelisches Krankenhaus Duesseldorf	Duesseldorf	Germany
Fondation Lenval Nice	Nice	France
Children’s Health Ireland	Dublin	Ireland
Children’s Health Ireland	Dublin	Ireland
CHRU De Nancy	Vandoeuvre Les Nancy	France
Euayyoc Uyiuavctlftm Mutxdpb Culaohz Rcglcczte (qnglsgq Mzf	Rotterdam	The Netherlands
Gmyemb Ufbcdxndzw Fyucrtprb	Frankfurt	Germany
Cpbb Ujgzlpsxmn Hucrkdjj	Cork	Ireland
Covamd Hdzyyagoqmv Rhqnhhxr Dcohntfveuylch	Angers	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	18.01.2024
Germany	Not recruiting	18.01.2024
Ireland	Not recruiting	18.01.2024
Spain	Not recruiting	18.01.2024
The Netherlands	Not recruiting	18.01.2024

Trial locations

Investigated drugs:

DBV712 is a type of treatment designed to help children who are allergic to peanuts. It works by gradually exposing the skin to small amounts of peanut protein, which can help the body become less sensitive to peanuts over time. This method is known as epicutaneous immunotherapy, and it aims to increase the child’s tolerance to peanuts, reducing the risk of severe allergic reactions. The treatment is applied to the skin, and the goal is to make it safer for children to be around peanuts without having a strong allergic response.

Peanut allergy – Peanut allergy is an immune system reaction that occurs soon after exposure to peanuts. It is one of the most common causes of severe allergy attacks. The progression involves the immune system mistakenly identifying peanut proteins as harmful, triggering the release of chemicals that cause allergy symptoms. Symptoms can range from mild, such as skin reactions and digestive problems, to severe, such as anaphylaxis, which requires immediate medical attention. The severity of the reaction can vary with each exposure. Over time, some individuals may experience changes in the severity of their reactions.

Trial ID:

2022-502110-85-00

Protocol code:

V712-306

NCT ID:

NCT05741476

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of DBV712 for Peanut Allergy in Children Aged 4-7

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