🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT05741476
Active, not recruiting Phase 3

Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age

NCT05741476 · tracked via the Priya Life Science UK tracker
Sponsor
DBV Technologies
Phase
Phase 3
Started
2023-02-21
Last updated
2026-01-22

Condition(s) studied

Allergy, Peanut

Investigational drug(s) / intervention(s)

DBV712PlaceboDBV712

DBV712: DBV712 250 mcg epicutaneous system.

Placebo: DBV712 matching placebo epicutaneous system.

DBV712: DBV712 250 mcg epicutaneous system.

Study summary

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)

Trial sites (87)

FacilityCityRegionStatus
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.

More DBV Technologies trials in the UK

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 NCT05741476 on ClinicalTrials.gov ↗ ← All trials in the UK