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Safety Study of Viaskin® Peanut Patch in Peanut-Allergic Children 1 Through 3 Years of Age (COMFORT Toddlers)

Studying peanut allergy patch safety for kids aged 1-3.

Recruiting
1-3 years
All
Phase 3
Study Overview: This study is testing a new treatment called **Viaskin® Peanut Patch** for very young children (1-3 years old) with peanut allergies. We want to see if it's safe to use for 6 months. The patch gives a tiny amount of peanut protein through the skin to help the body get used to peanuts. Study Details: The study lasts for about 112 weeks in total. It starts with a **6-week screening** to check if your child is a good match. Then, there are three parts: a **26-week treatment** period with either the real patch or a placebo (a patch with no active ingredient), a **78-week open-label extension** where all participants receive the real patch, and a **2-week follow-up**. Key Points:
  • The study involves regular visits to the clinic for monitoring your child's safety and health.
  • Participants will be randomly assigned to receive either the real treatment or placebo first, but everyone has the chance to try the real patch later.
  • It's important that your child continues to follow a peanut-free diet during the study.
Study details
    Allergy
    Peanut Allergy

NCT07003919

DBV Technologies

7 March 2026

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