Peanut allergy is a big part of your child's life. The VITESSE study can be, too.

The VITESSE 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.

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Study Overview

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 desensitise (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.

  • How effective?
  • How reliable?

Who can join?

To participate in the VITESSE study, your child must be:

  • 4-7 years of age

  • Diagnosed with peanut allergy

  • Currently following a strict peanut-free diet

There are other rules for taking part that the study staff will discuss with you and your child.

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What will happen if your child takes part?

If your child meets the initial selection criteria and you agree that they can participate in the study, the following will occur:

Screening Period (4 weeks)

To ensure participants qualify, Study Staff will:

  • Check the history of your child's peanut allergy
  • Perform blood and skin test
  • Perform a food challenge over the course of 2 days to determine your child's sensitivity to peanuts

Treatment Period (12 months)

If your child qualifies for study participation, he/she 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
  • Have medical exams
  • Have blood tests
  • Undergo a second 2 day food challenge to determine how well the treatment has worked after 12 months of treatment

Follow-Up Period (2 weeks)

After the treatment ends and 2 weeks after the last food challenge, study participants will:

  • Attend 1 additional study visit
  • Have physical exams

Why participate in a clinical study?

A clinical study is a research study that tries to answer questions about how medicines work in the people who take them. Researchers run studies to test whether an investigational medication is safe and effective. These studies may help doctors find new ways to help prevent, detect, or treat health problems. Information learned from this clinical research study may help other people with similar conditions in the future.

Additional care may also be provided for those participating. This may include:

  • Study Related Care
  • Reimbursement for Time and Travel

What requirements are in place to help protect clinical trial participants?

There are rules in place to help protect the safety, rights and well-being of people who volunteer for research studies. These rules are put in place to make sure studies follow strict scientific and ethical guidelines. Before a clinical research study can begin, a review board must review the study. This group is called an institutional review board (IRB), or an Ethics Committee (EC). IRBs and ECs are made up of doctors, scientists, and members of the community.

Is participation in this clinical trial mandatory? Will it cost anything?

Taking part in this study is voluntary and your child may stop at any time for any reason.

In addition, there is no cost for the study drug or study-related care, tests and exams.

Is there a VITESSE Study site near me?

If you would like to see if your child is eligible to participate, please find a site nearby.

Find a study site near me

Is there a VITESSE Study site near me?

If you would like to see if your child is eligible to participate, please find a site nearby.

Find a study site near me

Where can I learn more?

If you're interested in learning more about the VITESSE study for peanut allergy, including potential risks and benefits of participation, you can find additional details at CTGOV.