A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy With Dbv712 250 Mcg in 1-Through 3-Year-Old Children With Peanut Allergy

Studying the Safety of a Skin Patch for Peanut Allergy in Young Children

G
Girish Vitalpur, MD

Primary Investigator

Enrolling By Invitation
1 years - 3 years
All
Phase 3
3 participants needed
1 Location

Brief description of study

The primary objective of this study is to assess the 6-month safety of DBV712 250 micrograms (mcg) in subjects 1 through 3 years of age with peanut allergy.

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

This is a Phase 3 randomized double-blind, placebo-controlled (DBPC) study of 6-months duration to assess the safety of DBV712 250 mcg in subjects 1 through 3 years of age with peanut allergy. Participants who complete the 6-month DBPC period will be eligible to enter an optional 18-month open-label extension (OLE).  

The overall maximum study duration for each participant will be approximately 112 weeks: Screening Period of 6-weeks, DBPC Treatment Period of 26-weeks, Open-label Period of 78-weeks and Follow-up Period of 2-weeks.

Randomization of eligible participants will occur in a 3:1 ratio to DBV712 250 mcg (active treatment) or placebo, respectively.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Peanut Allergy, Riley
  • Age: 1 years - 3 years
  • Gender: All

Key Inclusion Criteria:

  • Aged 1 through 3 years at Visit 1 (screening).
  • Physician-diagnosed peanut allergy and following a strict peanut-free diet
  • Peanut-specific IgE > 0.7 kUA/L.
  • A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
  • An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).

Key Exclusion Criteria:

  • Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
  • Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
  • Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
  • History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
  • Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
  • Uncontrolled persistent asthma.

This study investigates the safety of an investigational treatment for peanut allergy in children aged 1 through 3 years. Peanut allergy is a condition where the body's immune system reacts to peanuts, causing allergic reactions. The purpose of this study is to assess the safety of a skin patch treatment, which contains 250 micrograms of the investigational medication, over a period of 6 months.

Participants in the study will be randomly assigned to receive either the investigational skin patch or a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the active treatment or the placebo. After the 6-month period, participants can choose to join an 18-month open-label extension where all will receive the investigational treatment.

  • Who can participate: Children aged 1 through 3 years with a peanut allergy diagnosed by a doctor and a peanut-specific IgE level greater than 0.7 kUA/L can participate.
  • Study details: Participants will use a skin patch daily that contains either the investigational medication or a placebo for 6 months, followed by an optional 18-month period where all receive the investigational treatment. The study will last approximately 112 weeks.
  • Study timelines: The study will last approximately 112 weeks.
Updated on 06 Mar 2026. Study ID: PPUL-DBV-DBV712-COMFORT, 27977
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only