Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age (NCT05741476) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Children 4-7 Years of Age
United States600 participantsStarted 2023-02-21
Plain-language 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.
Who can participate
Age range4 Years – 7 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 biol…
What they're measuring
1
DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group