Hero image with Pittsburgh background https://pittplusme.org/study/2637

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 

IRB: PRO00069099
- 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)

RESEARCH AREAS & CONDITIONS:
  Precision Medicine

PHONE NUMBER: 1-866-438-8230
SHARE STUDY
Printer Printer   Email A FriendEmail A Friend   ShareShare   TweetTweet   Linked-InLinked-In

INTERESTED?

Visit https://pittplusme.org/study/2637 and click on "I'm Interested" or call 1-866-438-8230.


LEARN MORE

PittPlusMe.org
1-866-438-8230
PittPlusMe@pitt.edu
@PittPlusMe
@PittPlusMe

MEET THE RESEARCHER


Deborah Albright

Deborah Albright, MD, is an allergy & immunology specialist in Pittsburgh. A graduate of the University of Pittsburgh, Dr. Albright’s research interests include allergy & immunology and pediatrics.