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Study of DBV712 skin patch safety in children aged 1-3 years with peanut allergy

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study focuses on children aged 1-3 years with peanut allergy. The main treatment being tested is Viaskin Peanut (DBV712), which is a special patch containing peanut extract that is placed on the skin. This treatment method is called epicutaneous immunotherapy, meaning it delivers the treatment through the skin. The study will compare the treatment patch containing 250 micrograms of peanut extract against a placebo patch that looks the same but contains no peanut proteins.

The purpose of this research is to evaluate how safe the peanut patch treatment is when used for 6 months in very young children with peanut allergy. During the study, participants will also undergo skin prick tests using special solutions to check their allergic responses. They will receive either the active treatment patch or placebo patch, which needs to be applied to the skin daily.

The study will track various safety aspects, including any reactions at the patch site and other health effects. Researchers will also monitor changes in the body's immune response to peanuts by measuring specific antibodies in the blood and conducting skin tests. The treatment period will last for 24 months, during which participants will be regularly monitored for any side effects or allergic reactions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial skin testing and challenge

    You will undergo a skin prick test using special solutions to confirm peanut allergy. This involves applying small drops of test substances on your skin.

    A food challenge test will be performed using different concentrations of peanut protein paste (placebo, low dose 6.6 mg/g, and high dose 133.3 mg/g) taken by mouth.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either the DBV712 patch containing 250 micrograms of peanut protein or a placebo patch that looks identical but contains no peanut protein.

    The patch will need to be applied to your skin daily.

  3. Step 3

    Daily patch application

    You will need to apply a new patch each day for 6 months.

    The application site will be checked for skin reactions such as itching, redness, or swelling.

    Your caregiver will need to record information about how the patch stays in place and any skin reactions.

  4. Step 4

    Regular monitoring

    You will have regular check-ups that include physical examinations and vital signs monitoring.

    Blood tests will be taken to measure changes in your immune response to peanuts.

    Skin prick tests will be repeated to measure changes in allergic response.

  5. Step 5

    Safety monitoring

    Any allergic reactions or side effects will be recorded throughout the study.

    You must maintain a strict peanut-free diet during the entire study period.

    You must keep emergency medication, including an epinephrine auto-injector, available at all times.

  6. Step 6

    Study completion

    The study will conclude after 6 months of treatment.

    Final assessments will include blood tests, skin prick tests, and physical examination.

Who can join the trial?

7 criteria

  • Child must be between 1 and 3 years old at the first visit
  • Child must have either: - A diagnosed peanut allergy from a doctor, or - A strong suspicion of peanut allergy confirmed by a doctor
  • Child must have all of these test results: - Positive blood test showing peanut-specific antibodies - Positive skin prick test with a reaction size of at least 6 millimeters - Positive reaction during a supervised peanut challenge test
  • Child must follow a strict peanut-free diet
  • Child must have: - Emergency medications available at all times - An epinephrine auto-injector (emergency injection pen) - A current food allergy emergency plan
  • Parent or legal guardian must sign an informed consent form
  • Both child and parents/caregivers must be willing to follow all study requirements

Who cannot join the trial?

12 criteria

  • History of severe anaphylactic reaction (life-threatening allergic reaction) to peanuts requiring hospitalization
  • Participation in another clinical trial within the past 30 days
  • Current use of medications that could interfere with the study results, including regular use of antihistamines (allergy medications)
  • Presence of skin conditions that could affect patch application, such as eczema (inflammatory skin condition) in the patch application area
  • Known allergies to any components of the study medication (DBV712)
  • Significant medical conditions that could affect study participation, including severe asthma or other serious chronic diseases
  • Children who cannot follow study procedures or attend regular visits
  • History of not following medical treatment plans
  • Children outside the age range of 1-3 years
  • Recent (within 3 months) use of other experimental treatments for peanut allergy
  • Current use of immunotherapy (treatments that modify immune system response) for any food allergies
  • Inability of parent/guardian to provide informed consent
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Investigated drugs

DBV712 is an immunotherapy patch applied to the skin (epicutaneous) designed to treat peanut allergies. This medication works by exposing the immune system to small amounts of peanut protein through the skin, with the goal of building tolerance to peanuts. It's specifically being studied for young children between 1 and 3 years old who have peanut allergies. Unlike traditional allergy medications that treat symptoms, this therapy aims to help the body become less sensitive to peanuts over time.

What is already known about the treatment

DBV712 - An investigational immunotherapy medication administered through an epicutaneous (on the skin) patch system, specifically designed to treat peanut allergies in young children aged 1 to 3 years. This novel treatment works by delivering controlled amounts of peanut protein through the skin, gradually helping the immune system develop tolerance to peanut allergens. The medication, currently being studied in Phase 3 clinical trials, represents a potential breakthrough in food allergy treatment as it offers a non-invasive approach compared to traditional oral immunotherapy. DBV712 belongs to the class of immunomodulating agents and is being evaluated for its safety profile and effectiveness in reducing allergic reactions to peanuts in young children.

Investigated diseases

Peanut Allergy - A food allergy that occurs when the immune system mistakenly identifies peanut proteins as harmful substances. The condition typically develops in early childhood and causes an allergic reaction when a person comes into contact with or consumes peanuts or peanut-containing foods. When exposed to peanuts, the body releases chemicals that can cause symptoms ranging from mild (such as hives or itching) to more severe reactions. The immune response can affect multiple body systems, including the skin, digestive tract, and respiratory system. The sensitivity to peanuts can vary greatly among individuals, and reactions can occur from even tiny amounts of peanut protein.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2025-521697-34-00Protocol codeV712-308Estimated enrolment450 patientsSponsorDbv Technologies

sourced from the EU Clinical Trials Register and site verification

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