EPITOPE Study – Toddlers Aged 1-3 with Peanut Allergy

STUDY BASICS

Are you the parent of a 1-3 year old who has a peanut allergy? If so, you may be able to participate in the “EPITOPE” research study to find out if an investigational new drug, a novel desensitization method, called EPicutaneous ImmunoTherapy (EPIT) with the Viaskin® Peanut patch is safe and effective for children with peanut allergies.

STUDY PURPOSE

The purpose of the this study is to find out if an investigational (not FDA-approved) new drug called Viaskin® Peanut is safe and effective for children with peanut allergies. Viaskin® Peanut is a specially designed patch applied on the skin that contains a dry extract of peanut proteins. Current research suggests that repeated exposures to very low amounts of peanut proteins can desensitize peanut-allergic children and may help prevent or reduce the severity of an allergic reaction if peanuts or peanut-containing foods are eaten accidentally.

COULD THIS STUDY BE RIGHT FOR YOUR CHILD?

• Ages 1-3 years old (may enroll until the day before the child turns 4)
• Have a physician-diagnosed peanut allergy

WHAT PARTICIPANTS CAN EXPECT

You and your child will have an initial screening visit that includes blood work and skin prick testing.  If these results meet study requirements, your child will then participate in two double-blind food challenges to find out if your child is eligible to participate in the study. If eligible, your child will then be randomly assigned (like drawing straws) to receive a patch that contains the study drug, called the Viaskin® Peanut patch, or a patch that does not contain the study drug (called a placebo). Neither you nor the study doctor will be able to pick which study group your child is in. However, children who receive the placebo patch can receive the Viaskin® Peanut patch after the first year if desired in an Open Extension Study.

During the study, your child will have 12 in-person visits over a period of about 60 weeks (1 year and 2 months). A member of the study team will also call you 5 times during the study. Study assessments include completing questionnaires, having physical exams and blood draws, and filling out a study diary.

Participants will be reimbursed for study-related expenses.