VITESSE Study

STUDY BASICS

Are you the parent of a child ages 4-7? Are they allergic to peanuts? You and your child may be eligible for a research study to evaluate an investigational drug patch called DBV712 for 4-7 year old children with peanut allergy. Compensation is provided.

STUDY PURPOSE

This study is evaluating an investigational drug patch called DBV712 for 4 to 7 year old children with peanut allergy. The main purpose of this study is to learn how well the study drug patch (DBV712) works and how safe it is compared with a placebo patch in children with peanut allergy. The small amount of peanut protein in the study drug patch is designed to potentially desensitize (or make less sensitive) a peanut-allergic person by repeated exposures to very small amounts of peanut via the skin. You and your child will be asked to attend at least 12 study visits over a period of approximately 58 weeks (about 1 year) during which you will apply one study drug patch per day to your child's back. 

 

COULD THIS STUDY BE RIGHT FOR YOUR CHILD?

Eligible participants are children:

• Ages 4-7
• Currently following a strict peanut-free diet 
• Diagnosed with peanut allergy

WHAT PARTICIPANTS CAN EXPECT

This study is divided into 3 periods: a screening period, a study treatment period, and a follow-up period. During each study period, you and your child will have 1 or more visits with the study doctor at the center. The screening visits will last about 3-4 hours, the double-blind placebo-controlled food challenge visits may last up to 6 hours, and all other visits will last about 2-3 hours. 

If your child qualifies for study participation, they will:

• Be randomly assigned (by chance) to receive the study drug (DBV712) patch or placebo patch. Participants will have about a 67% (2 in 3) chance of receiving the DBV712 patch and about a 33% (1 in 3) chance of receiving the placebo patch. 
• Attend 12 study visits to a research clinic 
• Receive 5 calls from research staff
• Maintain a daily eDiary to record treatment details, including time of application/removal of the patch each day and other patch related details 
• Apply daily patch to their back 
• Have an emergency action plan in case of allergic reactions 
• Have physical exams, medical exams, and blood tests 
• Undergo a second 2 day food challenge to determine how well the treatment has worked after 12 months of treatment