THRIVE
Research type
Research Study
Full title
A Phase 2, Open Label Study to Assess Ad Lib Consumption of Peanut in Peanut Allergic Infants 6-through 12-months-old with Epicutaneous Immunotherapy with DBV712 250 μg (THRIVE).
IRAS ID
1013761
Contact name
Roxane Castan
Contact email
Sponsor organisation
DBV Technologies S.A
ISRCTN Number
ISRCTN00000
Clinicaltrials.gov Identifier
NCT0000000
Research summary
Peanut allergy is one of the most serious food allergies in young children, where even tiny amounts of peanut can trigger life-threatening reactions requiring emergency treatment. The THRIVE study is testing whether a small skin patch can help peanut-allergic babies gradually build tolerance to peanut, so they can eventually eat it freely and safely as part of their normal daily diet.The DBV712 patch is a ready-to-use and easy-to-administer study treatment, which contains a very small amounts of peanut protein (~ 1/1000 of 1 peanut kernel). It is designed to desensitize (make less sensitive) peanut-allergic participants, and therefore to reduce the risk of reaction in case of accidental exposure to peanut. Participants wear the patch daily, with a new patch applied every day, on their upper back for 3 years. During these 3 years, participants will be instructed to avoid ingesting (eating) peanut-containing foods and will attend regular clinic visits. After 3 years of treatment, a food challenge (where the child eats gradually increasing amounts of peanut under monitored conditions) will be performed for all participants; depending on how much peanut the participant is able to eat without having symptoms, there will be 1 of 3 possible pathways for the 4th year,stop the patch and begin eating peanut-containing foods; continue the patch and begin eating peanut-containing foods; stop the patch and continue avoiding peanut.Around 250 peanut-allergic babies aged 6–12 months will take part of the study. The study lasts just over 4 years per child.
The main goal is to find out how many children can freely eat peanut in everyday life after 3 years of treatment. The results will also provide information about the safety of the patch, changes in the immune system over time, and quality of life for children and their families. Safety is monitored carefully throughout; all families receive an adrenaline prescription and a written emergency allergy plan at each clinic visit.REC name
South Central - Oxford A Research Ethics Committee
REC reference
26/SC/0194
Date of REC Opinion
7 Jul 2026
REC opinion
Further Information Favourable Opinion