Clinical Trials in Spain / NCT07003919
Active, not recruiting
Phase 3
Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)
NCT07003919 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
AllergyPeanut Allergy
Investigational drug(s) / intervention(s)
DBV712 250 mcgPlacebo
DBV712 250 mcg: DBV712 250 mcg epicutaneous system.
Placebo: DBV712 matching placebo epicutaneous system.
Study summary
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.
Eligibility
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.
Primary outcome measure(s)
- DBPC Treatment Period: Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs) — Through DBPC Treatment Period, 6 months
Trial sites (91)
| Facility | City | Region | Status |
|---|---|---|---|
| AllerVie Clinical Research | Birmingham | Alabama | |
| University of Alabama at Birmingham Pediatric Primary Care Clinic | Birmingham | Alabama | |
| Modena Allergy & Asthma | Scottsdale | Arizona | |
| University of Arizona Asthma and Airway Disease Research Center | Tucson | Arizona | |
| Arkansas Children's Hospital | Little Rock | Arkansas | |
| Modena Allergy & Asthma | La Jolla | California | |
| Modena Allergy and Asthma | Long Beach | California | |
| UCLA Health Westwood Pediatrics | Los Angeles | California | |
| Children's Hospital of Los Angeles | Los Angeles | California | |
| Allergy & Asthma Associates of Southern California | Mission Viejo | California | |
| Lucile Packard Children's Hospital Stanford | Palo Alto | California | |
| Allergy & Asthma Medical Group and Research Center | San Diego | California | |
| Rady Children's Hospital - San Diego | San Diego | California | |
| Orso Health Torrance | Torrance | California | |
| Children's Hospital Colorado | Aurora | Colorado | |
| Asthma & Allergy Associates | Colorado Springs | Colorado | |
| Children's National - Main Hospital | Washington D.C. | District of Columbia | |
| University of South Florida Children's Research Institute | St. Petersburg | Florida | |
| Allergy, Asthma & Immunology Associates of Tampa Bay | Tampa | Florida | |
| Emory University - Children's Healthcare of Atlanta, Inc. | Atlanta | Georgia | |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | |
| University of Chicago Medicine Comer Children's Hospital | Chicago | Illinois | |
| Sneeze, Wheeze and Itch Associated, LLC | Normal | Illinois | |
| Deaconess Clinic - Downtown Evansville | Evansville | Indiana | |
| Riley Hospital for Children at Indiana University Health | Indianapolis | Indiana | |
| The University of Kansas Health System - Main Campus, Medical Pavilion | Kansas City | Kansas | |
| Johns Hopkins Hospital | Baltimore | Maryland | |
| Allergy Asthma Specialists of Maryland - White Marsh | White Marsh | Maryland | |
| MassGeneral Hospital for Children | Boston | Massachusetts | |
| Boston Children's Hospital | Boston | Massachusetts | |
| Regents of the University of Michigan | Ann Arbor | Michigan | |
| Allergy and Immunology Associates of Ann Arbor | Ann Arbor | Michigan | |
| Allergy and Asthma Research Center of Minnesota | Maplewood | Minnesota | |
| Mayo Clinic | Rochester | Minnesota | |
| Children's Mercy Hospital | Kansas City | Missouri | |
| St. Louis Children's Hospital | St Louis | Missouri | |
| Weiss Medical | Riverdale | New Jersey | |
| Northwell Health Allergy and Immunology at the Irving Goldman Family Care Center | Great Neck | New York | |
| NYU Langone Health | New York | New York | |
| Equity Medical | New York | New York |
+ 51 more sites — see the full list on the official registry below.
More DBV Technologies trials in Spain
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07003919 on ClinicalTrials.gov ↗ ← All trials in Spain