Study on Long-term Benefits and Safety of DBV712 for Children with Peanut Allergy

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What is this study about?

This clinical trial is focused on studying peanut allergy in children. The trial will use a treatment called Viaskin Peanut, which is a patch applied to the skin. The patch contains a small amount of peanut extract and is designed to help children with peanut allergies become less sensitive to peanuts over time. The study will also involve an oral paste made from peanut flour in different doses, including a low dose, a high dose, and a placebo, which is a substance with no active ingredient.

The purpose of the study is to evaluate the long-term benefits and safety of using Viaskin Peanut for up to three years. Children participating in the study will receive the treatment and be monitored to see if they become less sensitive to peanuts. The study will also check for any side effects or reactions to the treatment. The children will be given the treatment over a period of time, and their response to peanuts will be tested at different stages to see if the treatment is effective.

Throughout the study, researchers will collect information on how well the children tolerate peanuts and any changes in their allergy symptoms. The study aims to help understand if this treatment can provide a long-term solution for children with peanut allergies, making it safer for them to be around peanuts without having severe allergic reactions. The study will also look at the overall health and quality of life of the children during the treatment period.

1 joining the study

Participation begins after completing the previous EPITOPE study and signing the informed consent form by the parent or guardian.

The consent must be signed after completing the Month 12 procedures in the EPITOPE study.

2 initial assessment

An initial assessment is conducted to confirm eligibility and establish baseline measurements.

This includes a double-blind, placebo-controlled food challenge (DBPCFC) to determine the initial dose of peanut protein that can be tolerated.

3 treatment phase

The treatment involves the use of Viaskin Peanut, a cutaneous patch applied to the skin.

The patch contains 250 micrograms of peanut protein and is used for up to 3 years.

The goal is to induce or maintain desensitization to peanuts.

4 regular monitoring

Regular monitoring is conducted to assess the clinical benefit and safety of the treatment.

This includes evaluating the proportion of subjects reaching specific doses of peanut protein without symptoms.

Safety assessments include monitoring for adverse events and reactions at the patch site.

5 follow-up assessments

Follow-up assessments are conducted at intervals to measure the sustained clinical benefit.

These assessments include additional DBPCFCs to evaluate changes in peanut protein tolerance.

6 completion of study

The study is estimated to conclude by May 29, 2025.

Final assessments will be conducted to evaluate the long-term effects of the treatment.

Who Can Join the Study?

The child must have a peanut allergy.
The child’s parent(s) or guardian(s) must sign a form called an informed consent form. This form shows they understand the study and agree to let their child participate.
The child must have completed a previous study called the EPITOPE study. This includes finishing a specific test called DBPCFC (Double-Blind Placebo-Controlled Food Challenge) at the 12-month mark of that study.
The child’s parent(s) or guardian(s) and the child must be willing to follow all the rules and requirements of the study while participating.
The study is open to both boys and girls.
The study is for children aged 2 years and older.

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 2 and 17 cannot participate.
Children who have other serious health conditions that might interfere with the study cannot participate.
Children who are taking medications that might affect the study results cannot participate.
Children who have participated in other similar studies recently cannot participate.
Children who have a history of severe allergic reactions that are not related to peanuts cannot participate.
Children who have skin conditions that might affect the treatment cannot participate.
Children who are unable to follow the study instructions 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
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country	Status
Edmqfua Uqurjwbytwjw Mvhxzis Chomhwn Rkwomrqld (iomengf Mbl	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	06.12.2018
The Netherlands	Not recruiting	06.12.2018

Trial locations

Investigated drugs:

Viaskin Peanut is a treatment designed for children with peanut allergies. It is used in a method called epicutaneous immunotherapy, where the medication is applied to the skin. The goal of this treatment is to help children become less sensitive to peanuts over time, potentially allowing them to tolerate small amounts of peanuts without having an allergic reaction. This study aims to evaluate the long-term benefits and safety of using Viaskin Peanut for up to three years.

Peanut Allergy – Peanut allergy is a common food allergy that occurs when the immune system mistakenly identifies proteins in peanuts as harmful. This triggers an allergic reaction, which can range from mild symptoms like hives or itching to more severe reactions such as difficulty breathing or anaphylaxis. The progression of peanut allergy can vary; some individuals may experience more severe reactions over time, while others may have consistent symptoms. It is often diagnosed in childhood, and while some children may outgrow it, many continue to have the allergy into adulthood. The condition requires strict avoidance of peanuts and peanut-containing products to prevent allergic reactions.

Trial ID:

2024-515703-19-00

Protocol code:

V712-305/EPOPEX

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Long-term Benefits and Safety of DBV712 for Children with Peanut Allergy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?