Peanut patch could let allergic kids tolerate small amounts of peanut

NCT ID NCT05741476

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a daily skin patch called DBV712 (Viaskin Peanut) in 600 children aged 4-7 with peanut allergy. The patch delivers a tiny amount of peanut protein to train the immune system to be less sensitive. After 12 months, researchers check if children can safely eat more peanut than before without a reaction. The goal is to reduce the risk of severe reactions from accidental peanut exposure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DBV712 (Viaskin Peanut) – a skin patch that delivers a small amount of peanut protein to help the immune system get used to it
What this could lead to
If it works, this patch could allow children with peanut allergy to safely eat small amounts of peanut without a severe reaction, reducing the risk from accidental exposure.
What could go wrong
This is a phase 3 trial, but results are not yet final. The patch may not work for all children, and some may still have allergic reactions. Side effects like skin irritation or, rarely, severe allergic reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

4 to 7 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Aged 4 through 7 years at Visit 1 (screening). * Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet. * Peanut-specific IgE of \>0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1. * An ED of ≤100 mg peanut protein at screening DBPCFC. Participants may enter the Open-label Extension Period if they meet all of the following inclusion criteria: * Signed ICF by the participant's parent(s)/caregiver(s). This consent should be signed after completion of the procedures in the randomized, DBPC Treatment Period, and before any procedure in Open-label Extension Period begins. * Participants who perform the peanut DBPCFC at the end of Month 12 and have ≥80% compliance with investigational medicinal product (IMP). * Parent(s)/caregiver(s) and participants willing to comply with all study requirements during the participant's participation in the study. Key Exclusion Criteria: * Severe generalized dermatologic disease involving the application area (interscapular region) * Uncontrolled persistent asthma. * Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT). * Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1. Participants may not enter the Open-label Extension Period if they meet any of the following exclusion criteria: * Participants who develop a severe anaphylactic reaction during the DBPCFC at the end of Month 12 with the event requiring tracheal intubation or leading to a cardiac arrest and/or to coma. Participants with other reported cases of severe anaphylaxis will be considered eligible to participate in the Open-label Extension Period, at the judgement of the Investigator. * Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures.

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Conditions

The condition(s) this trial relates to.

food allergy Nut and Peanut Hypersensitivity Peanut Hypersensitivity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • DBV Investigative Site

    Birmingham, Alabama, 35233, United States

  • DBV Investigative Site

    Tucson, Arizona, 85724, United States

  • DBV Investigative Site

    Little Rock, Arkansas, 72202, United States

  • DBV Investigative Site

    Los Angeles, California, 90027, United States

  • DBV Investigative Site

    Los Angeles, California, 90095, United States

  • DBV Investigative Site

    San Diego, California, 92123, United States

  • DBV Investigative Site

    San Francisco, California, 94158, United States

  • DBV Investigative Site

    San Jose, California, 95117, United States

  • DBV Investigative Site

    Aurora, Colorado, 80045, United States

  • DBV Investigative Site

    Colorado Springs, Colorado, 80907, United States

  • DBV Investigative Site

    Washington D.C., District of Columbia, 20010, United States

  • DBV Investigative Site

    Hollywood, Florida, 33021, United States

  • DBV Investigative Site

    Miami, Florida, 33136, United States

  • DBV Investigative Site

    St. Petersburg, Florida, 33701, United States

  • DBV Investigative Site

    Tampa, Florida, 33613, United States

  • DBV Investigative Site

    Marietta, Georgia, 30060, United States

  • DBV Investigative Site

    Chicago, Illinois, 60611, United States

  • DBV Investigative Site

    Normal, Illinois, 61761, United States

  • DBV Investigative Site

    Indianapolis, Indiana, 46202, United States

  • DBV Investigative Site

    Louisville, Kentucky, 40215, United States

  • DBV Investigative Site

    Baltimore, Maryland, 21287, United States

  • DBV Investigative Site

    Chevy Chase, Maryland, 20815, United States

  • DBV Investigative Site

    Boston, Massachusetts, 02114, United States

  • DBV Investigative Site

    Boston, Massachusetts, 02115, United States

  • DBV Investigative Site

    Taunton, Massachusetts, 02780, United States

  • DBV Investigative Site

    Ann Arbor, Michigan, 48106, United States

  • DBV Investigative Site

    Ypsilanti, Michigan, 48197, United States

  • DBV Investigative Site

    Maplewood, Minnesota, 55109, United States

  • DBV Investigative Site

    Kansas City, Missouri, 64108, United States

  • DBV Investigative Site

    Great Neck, New York, 11021, United States

  • DBV Investigative Site

    New York, New York, 10016, United States

  • DBV Investigative Site

    New York, New York, 10029, United States

  • DBV Investigative Site

    Rochester, New York, 14642, United States

  • DBV Investigative Site

    Chapel Hill, North Carolina, 27599, United States

  • DBV Investigative Site

    Cincinnati, Ohio, 45229, United States

  • DBV Investigative Site

    Cleveland, Ohio, 44106, United States

  • DBV Investigative Site

    Cleveland, Ohio, 44195, United States

  • DBV Investigative Site

    Columbus, Ohio, 43205, United States

  • DBV Investigative Site

    Philadelphia, Pennsylvania, 19104, United States

  • DBV Investigative Site

    Pittsburgh, Pennsylvania, 15224, United States

  • DBV Investigative Site

    Memphis, Tennessee, 38105, United States

  • DBV Investigative Site

    Nashville, Tennessee, 37232, United States

  • DBV Investigative Site

    Austin, Texas, 78723, United States

  • DBV Investigative Site

    Dallas, Texas, 75235, United States

  • DBV Investigative Site

    Houston, Texas, 77030, United States

  • DBV Investigative Site

    Seattle, Washington, 98101, United States

  • DBV Investigative Site

    Seattle, Washington, 98115, United States

  • DBV Investigative Site

    Milwaukee, Wisconsin, 53226, United States

  • DBV Investigative Site

    Adelaide, 5006, Australia

  • DBV Investigative Site

    Nedlands, 6009, Australia

  • DBV Investigative Site

    Parkville, 3052, Australia

  • DBV Investigative Site

    Richmond, 3121, Australia

  • DBV Investigative Site

    South Brisbane, 4101, Australia

  • DBV Investigative Site

    Westmead, 2145, Australia

  • DBV Investigative Site

    Vancouver, British Columbia, V6H 3V4, Canada

  • DBV Investigative Site

    Winnipeg, Manitoba, R3J 0S9, Canada

  • DBV Investigative Site

    Burlington, Ontario, L7L6W6, Canada

  • DBV Investigative Site

    North York, Ontario, M3B3S6, Canada

  • DBV Investigative Site

    Ottawa, Ontario, M5G 1X8, Canada

  • DBV Investigative Site

    Toronto, Ontario, K1H1E4, Canada

  • DBV Investigative Site

    Montreal, Quebec, H3T 1C5, Canada

  • DBV Investigative Site

    Montreal, Quebec, H4A3J1, Canada

  • DBV Investigative Site

    Québec, Quebec, G1v4W2, Canada

  • DBV Investigative Site

    Hamilton, L8SIG5, Canada

  • DBV Investigative Site

    Angers, 49933, France

  • DBV Investigative Site

    Brest, 29609, France

  • DBV Investigative Site

    Bron, 69500, France

  • DBV Investigative Site

    Nice, 06200, France

  • DBV Investigative Site

    Strasbourg, 67091, France

  • DBV Investigative Site

    Vandœuvre-lès-Nancy, 54511, France

  • DBV Investigative Site

    Düsseldorf, 40217, Germany

  • DBV Investigative Site

    Frankfurt, 60590, Germany

  • DBV Investigative Site

    Ulm, 89075, Germany

  • DBV Investigative Site

    Cork, T12 DC4A, Ireland

  • DBV Investigative Site

    Dublin, D12N512, Ireland

  • DBV Investigative Site

    Rotterdam, 3015 CN, Netherlands

  • DBV Investigative Site

    Utrecht, 3584 EA, Netherlands

  • DBV Investigative Site

    Madrid, 28009, Spain

  • DBV Investigative Site

    Madrid, 28034, Spain

  • DBV Investigative Site

    Málaga, CP 29011, Spain

  • DBV Investigative Site

    London, SE1 7ETH, United Kingdom

  • DBV Investigative Site

    London, W2 1NY, United Kingdom

  • DBV Investigative Site

    Manchester, M13 9WL, United Kingdom

  • DBV Investigative Site

    Sheffield, S10 2TH, United Kingdom

  • DBV Investigative Site

    Southampton, SO16 6YD, United Kingdom

  • DBV Investigative site

    Mission Viejo, California, 92691, United States

  • DBV Investigative site

    Atlanta, Georgia, 30329, United States

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