ClinConnect ClinConnect Logo
Search / Trial NCT07003919

Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)

Launched by DBV TECHNOLOGIES · May 27, 2025

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Peanut Hypersensitivity Epicutaneous Immunotherapy (Epit) Epicutaneous Immunotherapy Viaskin Nut And Peanut Hypersensitivity Food Hypersensitivity Peanut Allergy Food Allergy Nut And Peanut Allergy Safety Study

ClinConnect Summary

This clinical trial, called the COMFORT Toddlers study, is looking at the safety of a peanut allergy treatment called the Viaskin® Peanut Patch in young children aged 1 to 3 years old. Specifically, the study will monitor how safe a small dose of the patch is over a period of six months for children diagnosed with peanut allergies. To be eligible for this trial, children must have been diagnosed with a peanut allergy by a doctor, must be following a strict diet that avoids peanuts, and must meet certain test results that indicate their allergy severity.

If your child qualifies and participates in this study, they will be closely monitored by medical professionals for any side effects from the patch during the six-month period. It's important to note that children who have had severe allergic reactions to peanuts or who are currently receiving treatment for their allergies may not be eligible to join the trial. This study is not yet recruiting participants, but it aims to gather valuable information to help improve peanut allergy treatments for young children.

Gender

ALL

Eligibility criteria

  • 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.

About Dbv Technologies

DBV Technologies is a clinical-stage biopharmaceutical company focused on developing innovative treatments for food allergies and other immunological conditions. Utilizing its proprietary Viaskin® technology, which employs a novel epicutaneous (skin) delivery system, DBV aims to provide safer and more effective therapeutic options for patients. The company is committed to advancing its pipeline through rigorous clinical trials, emphasizing patient-centered approaches and scientific rigor to address unmet medical needs in allergy management. With a strong emphasis on research and development, DBV Technologies strives to improve the quality of life for individuals affected by food allergies.

Locations

Charleston, South Carolina, United States

Philadelphia, Pennsylvania, United States

Rochester, New York, United States

Kansas City, Missouri, United States

Saint Louis, Missouri, United States

Austin, Texas, United States

Cincinnati, Ohio, United States

Baltimore, Maryland, United States

Houston, Texas, United States

Nashville, Tennessee, United States

San Diego, California, United States

Aurora, Colorado, United States

Bronx, New York, United States

New York, New York, United States

Little Rock, Arkansas, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Pittsburgh, Pennsylvania, United States

Colorado Springs, Colorado, United States

San Diego, California, United States

Palo Alto, California, United States

Montréal, Quebec, Canada

Dallas, Texas, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Boston, Massachusetts, United States

New York, New York, United States

Hamilton, Ontario, Canada

Québec, Quebec, Canada

Burlington, Ontario, Canada

Riverdale, New Jersey, United States

Birmingham, Alabama, United States

La Jolla, California, United States

Ottawa, Ontario, Canada

Ann Arbor, Michigan, United States

Birmingham, Alabama, United States

Tucson, Arizona, United States

Los Angeles, California, United States

Mission Viejo, California, United States

Washington, District Of Columbia, United States

Saint Petersburg, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Normal, Illinois, United States

Evansville, Indiana, United States

Kansas City, Kansas, United States

Ann Arbor, Michigan, United States

Maplewood, Minnesota, United States

Great Neck, New York, United States

Hershey, Pennsylvania, United States

Memphis, Tennessee, United States

San Antonio, Texas, United States

La Crosse, Wisconsin, United States

Winnipeg, Manitoba, Canada

Hamilton, Ontario, Canada

Toronto, Ontario, Canada

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported