RECRUITING

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

Talk to us

Conditions

AllergyPeanut AllergyPeanut hypersensitivityEpicutaneous Immunotherapy (EPIT)EpicutaneousImmunotherapyViaskinNut and Peanut HypersensitivityFood HypersensitivityFood AllergyNut and Peanut AllergySafety Study

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-24
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07003919

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Aged 1 through 3 years at Visit 1 (screening).
  2. * Physician-diagnosed peanut allergy and following a strict peanut-free diet
  3. * Peanut-specific IgE \> 0.7 kUA/L.
  4. * A positive peanut SPT with the largest wheal diameter of ≥ 6 mm at Visit 1 (screening).
  5. * An ED ≤ 300 mg peanut protein at screening double-blind placebo-controlled food challenge (DBPCFC).
  1. * Peanut allergic subjects presenting a medical history of severe anaphylaxis to peanut.
  2. * Severe generalized dermatologic disease involving the proposed treatment application area (interscapular region).
  3. * Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy).
  4. * History of any immunotherapy for peanut allergy, including Epicutaneous immunotherapy (EPIT), oral immunotherapy (OIT), sublingual immunotherapy (SLIT).
  5. * Treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
  6. * Uncontrolled persistent asthma.

Contacts and Locations

Study Contact

DBV Technologies
CONTACT
908-679-5200
clinicaltrials@dbv-technologies.com
DBV Technologies
CONTACT
908-679-5200

Study Locations (Sites)

Respiratory Medicine Research Institute
Ann Arbor, Michigan, 48197
United States

Collaborators and Investigators

Sponsor: DBV Technologies

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-24
Study Completion Date2028-05

Study Record Updates

Study Start Date2025-06-24
Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

  • Peanut hypersensitivity
  • Epicutaneous Immunotherapy (EPIT)
  • Epicutaneous
  • Immunotherapy
  • Viaskin
  • Nut and Peanut Hypersensitivity
  • Food Hypersensitivity
  • Peanut Allergy
  • Food Allergy
  • Nut and Peanut Allergy
  • Safety Study

Additional Relevant MeSH Terms

  • Allergy
  • Peanut Allergy