Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

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

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

30 criteria

  • 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.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

DBV712 – DBV712 is administered through a skin patch, a method known as epicutaneous immunotherapy, which involves placing the patch on the skin to deliver the medication. This treatment is currently being studied in clinical trials, specifically for its effectiveness and safety in children aged 4 to 7 years with peanut allergies. The main goal of DBV712 is to help these children become less sensitive to peanuts, reducing the risk of allergic reactions. At the molecular level, the medication works by gradually exposing the immune system to small amounts of peanut protein, aiming to build tolerance over time. DBV712 falls under the pharmacological classification of immunotherapy, which is a type of treatment designed to modify the immune system's response to allergens.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-502110-85-00Protocol codeV712-306Estimated enrolment600 patientsSponsorDbv Technologies

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).