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 States, Australia, Canada600 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 range
4 Years – 7 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
DBPC Treatment Period: Percentage of Treatment Responders in the DBV712 250 mcg Group Compared to Placebo Group