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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported