The VITESSE phase 3 clinical research study is looking for children 4 to 7 years of age who have been diagnosed with peanut allergy and are currently following a strict peanut-free diet. Study doctors are testing an investigational drug patch (also called study drug patch) to learn how well it works and how safe it is in children with peanut allergy.
What should I know about the VITESSE study?
To be eligible for this study, participants must be*:
- 4 to 7 years of age
- Diagnosed with peanut allergy
- Currently following a strict peanut-free diet
*Other inclusion/exclusion criteria will apply.
- This study will consist of at least 12 study visits and 5 phone calls over a period of approximately 58 weeks (about 1 year)
- Participants will be randomly assigned (by chance) to receive the study drug patch or placebo patch (looks like the study drug but contains no active drug). Participants will have about a 67% (2 in 3) chance of receiving the study drug patch and about a 33% (1 in 3) chance of receiving the placebo patch
- The health and safety of participants will be monitored throughout the study
- Participant data and information will be kept confidential according to applicable laws for clinical research studies
- Study participants will receive all study-related procedures and the study drug patch or placebo patch at no cost
Study sponsored by DBV Technologies