Clinical Trials / Research Studies

Peanut Allergy Patch Study for Children 4 to 7 Years Old

What will happen in the study?

The study includes 12 study visits over about 58 weeks. Here are some of the things that will happen in this study.

Your child will be randomly assigned (like flipping a coin) to receive either the DBV712 patch (study drug patch) or the placebo patch which does not have any active study drug. Both patches will look the same and be placed in the same area of your child’s back.

You will:

• Be asked for information about your child and his/her past illnesses and diagnoses, treatments, current and past medications, etc.
• Complete questionnaires.
• Be asked to complete an electronic diary during your entire participation in the study and take photos of the study drug patch before removing it each day.
• Be asked to score how well the study drug patch sticks to the skin of your child and list any reasons why the study drug patch detached, fell off or was removed earlier than the recommended time, if it happens, and whether the removal was easy, painful, or caused skin injury.

Your child will:

• Have physical exams and vital signs taken at each study visit.
• Have blood samples collected.
• Have skin prick testing which involves small pricks in the skin with drops of peanut allergy testing liquid on his/her back or forearm skin to check for reactions.
• Complete lung function tests.
• Complete two different food challenges, which will include one with peanut butter. If your child has a reaction to the suspected food, the challenge will be stopped. He/she will also be monitored for at least 2 hours after each food challenge.

Prior to the start of the study, you will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and answer your questions.