Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age (EPITOPE)
Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age (EPITOPE)
The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 414 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Placebo-controlled, Randomized Phase III Trial to Assess the Safety and Efficacy of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age.
Actual Study Start Date: July 31, 2017
Estimated Primary Completion Date: April 2022
Estimated Study Completion Date: April 2022
Arm:
- Experimental: Viaskin Peanut 250 mcg
- Experimental: Viaskin Peanut 100 mcg
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Actual enrolment | 414 |
| Actual Study start date | 31 July 2017 |
| Estimated Study Completion Date | 01 April 2022 |