Efficacy and Safety of Viaskin Peanut in children with Peanut Allergy(VITESSE)
Research type
Research Study
Full title
A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of Epicutaneous Immunotherapy with DBV712 250 μg in 4-7-year-old Children with Peanut Allergy (VITESSE)
IRAS ID
1007465
Contact name
Fanny Vincent
Contact email
Sponsor organisation
DBV Technologies S.A.
Research summary
Peanut allergy is one of the most common causes of food allergies, and the number of children with peanut allergy is increasing. Allergic reactions to peanuts are usually immediate and can affect(s) different parts of the body, such as the skin, lungs, intestines, heart, and nervous system.
The main purpose of this study is to learn how well DBV712 works, and how safe it is compared with a placebo patch over a 12-month treatment period in children aged 4 to 7 years with peanut allergy. A placebo patch is an identical patch with inactive material that looks like the DBV712 patch but does not have any active study drug. Researchers use a placebo to see if the DBV712 works better or is safer than taking nothing.
DBV712 is a medication using a specially designed patch applied on the skin that contains a dry extract of peanut protein. The small amount of peanut protein (approximately 1/1000 of that in a peanut) is designed to de sensitise (make a person less sensitive) to peanut. By using the study drug patch, the aim is to prevent and/or reduce the severity of any reaction a person with peanut allergy might have if they accidentally eat some peanut.
Participants will be in this study for approximately 58 weeks, and they will need to come to the study centre at least 12 times over this period. In addition, a member of the study team will also call the participants minimum of 5 times during the study period.
This study is divided into 3 periods: a screening period, a treatment period, and a follow-up period. During each study period, participants will have 1 or more visits with the study doctor at the centre. The screening visits will last about 3-4 hours, the food challenge visits may last up to 6 hours, and all other visits will last about 2-3 hours.
The study will take place in approximately 80 centres in North America, Europe, and Australia with about 600 children (aged 4 to 7 years) with a peanut allergy participating.REC name
London - Central Research Ethics Committee
REC reference
23/LO/0382
Date of REC Opinion
26 Sep 2023
REC opinion
Further Information Favourable Opinion