The primary purpose of this study is to assess the efficacy and safety of daily DBV712 250 micrograms (mcg) to induce desensitization to peanut in peanut-allergic children 4-7 years of age over a 12-month double-blind, placebo-controlled (DBPC) Treatment Period.
Eligibility
Sex
ALL
Min age
4 Years
Max age
7 Years
Healthy volunteers
No
Key Inclusion Criteria:
* Aged 4 through 7 years at Visit 1 (screening).
* Physician-diagnosed peanut allergy or children with a well-documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet.
* Peanut-specific IgE of \>0.7 kilo allergy unit per liter (kUA/L) and a positive peanut SPT with the largest wheal diameter of ≥6 millimeter (mm) at Visit 1.
* An ED of ≤100 mg peanut protein at screening DBPCFC.
Participants may enter the Open-label Extension Period if they meet all of the following inclusion criteria:
* Signed ICF by the participant's parent(s)/caregiver(s). This consent should be signed after completion of the procedures in the randomized, DBPC Treatment Period, and before any procedure in Open-label Extension Period begins.
* Participants who perform the peanut DBPCFC at the end of Month 12 and have ≥80% compliance with investigational medicinal product (IMP).
* Parent(s)/caregiver(s) and participants willing to comply with all study requirements during the participant's participation in the study.
Key Exclusion Criteria:
* Severe generalized dermatologic disease involving the application area (interscapular region)
* Uncontrolled persistent asthma.
* Past or current immunotherapy for peanut allergy, including oral immunotherapy (OIT).
* Current immunotherapy for any allergen (including food allergy, allergic rhinitis and/or insect allergy), or treatment with any monoclonal antibody or biologic immunomodulatory therapy within 6 months prior to Visit 1.
Participants may not enter the Open-label Extension Period if they meet any of the following exclusion criteria:
* Participants who develop a severe anaphylactic reaction during the DBPCFC at the end of Month 12 with the event requiring tracheal intubation or leading to a cardiac arrest and/or to coma. Participants with other reported cases of severe anaphylaxis will be considered eligible to participate in the Open-label Extension Period, at the judgement of the Investigator.
* Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures.
Primary outcome measure(s)
DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group — At Month 12 A participant is defined as a treatment responder if: The initial ED was ≤30 mg peanut protein and the ED is ≥ 300 mg peanut protein at the post-treatment DBPCFC at Month 12; OR the initial ED was \> 30 mg peanut protein and the ED is ≥600 mg peanut protein at the post-treatment DBPCFC at Month 12. Percentage of treatment responders in the DBV712 250 mcg group compared to the placebo group after 12 months of treatment in the target population will be reported.
Trial sites (87)
Facility
City
Region
Status
DBV Investigative Site
Birmingham
Alabama
DBV Investigative Site
Tucson
Arizona
DBV Investigative Site
Little Rock
Arkansas
DBV Investigative Site
Los Angeles
California
DBV Investigative Site
Los Angeles
California
DBV Investigative site
Mission Viejo
California
DBV Investigative Site
San Diego
California
DBV Investigative Site
San Francisco
California
DBV Investigative Site
San Jose
California
DBV Investigative Site
Aurora
Colorado
DBV Investigative Site
Colorado Springs
Colorado
DBV Investigative Site
Washington D.C.
District of Columbia
DBV Investigative Site
Hollywood
Florida
DBV Investigative Site
Miami
Florida
DBV Investigative Site
St. Petersburg
Florida
DBV Investigative Site
Tampa
Florida
DBV Investigative site
Atlanta
Georgia
DBV Investigative Site
Marietta
Georgia
DBV Investigative Site
Chicago
Illinois
DBV Investigative Site
Normal
Illinois
DBV Investigative Site
Indianapolis
Indiana
DBV Investigative Site
Louisville
Kentucky
DBV Investigative Site
Baltimore
Maryland
DBV Investigative Site
Chevy Chase
Maryland
DBV Investigative Site
Boston
Massachusetts
DBV Investigative Site
Boston
Massachusetts
DBV Investigative Site
Taunton
Massachusetts
DBV Investigative Site
Ann Arbor
Michigan
DBV Investigative Site
Ypsilanti
Michigan
DBV Investigative Site
Maplewood
Minnesota
DBV Investigative Site
Kansas City
Missouri
DBV Investigative Site
Great Neck
New York
DBV Investigative Site
New York
New York
DBV Investigative Site
New York
New York
DBV Investigative Site
Rochester
New York
DBV Investigative Site
Chapel Hill
North Carolina
DBV Investigative Site
Cincinnati
Ohio
DBV Investigative Site
Cleveland
Ohio
DBV Investigative Site
Cleveland
Ohio
DBV Investigative Site
Columbus
Ohio
+ 47 more sites — see the full list on the official registry below.
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.
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