NCT02636699

Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy

A Double-blind, Placebo-controlled, Randomized Phase 3 Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy With Viaskin Peanut in Peanut-allergic Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: DBV Technologies · Industry
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The PEPITES study evaluates the efficacy and safety of Viaskin Peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous immunotherapy (EPIT).

Detailed description

This is a 12-month, Phase III, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of Viaskin Peanut, dosed at 250µg peanut protein (per patch) in peanut-allergic children from 4 through 11 years of age. The overall maximum study duration for each subject is approximately 61 weeks (6-week screening period, 12-month treatment period and 2-week follow-up period). During the screening period, subjects will undergo a first screening visit and an entry double-blind, placebo-controlled food challenge (DBPCFC) to peanut to confirm their allergy and their entry peanut eliciting dose (ED). The starting dose of the challenge will be 1 mg peanut protein and will escalate up to a highest dose of 300mg peanut protein. Subjects who react at or below the dose of 300mg peanut protein are considered eligible. Randomization of eligible subjects will occur in a 2:1 ratio to Viaskin Peanut dosed at 250µg peanut protein (active treatment) or placebo. Subjects will be stratified at randomization by their entry/screening DBPCFC ED in 1 of the following 2 strata and by study center: * Stratum 1: children with a screening ED of 1mg, 3mg or 10mg; * Stratum 2: children with a screening ED of 30mg, 100mg or 300mg. Subjects will apply a Viaskin patch containing either peanut protein or placebo daily for a period of 12 months. At Month 12, a post-treatment DBPCFC to peanut will be performed, with a starting dose of 1 mg peanut protein with escalation up to a highest dose of 2,000 mg peanut protein. This evaluation will help determine the primary efficacy endpoint of this pivotal study.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
BIOLOGICAL	Viaskin Peanut 250mcg	Peanut extract cutaneous patch
BIOLOGICAL	Placebo	Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-08-18
• Completion: 2017-08-18
• First posted: 2015-12-22
• Last updated: 2025-06-18
• Results posted: 2021-10-15

Locations

31 sites across 5 countries: United States, Australia, Canada, Germany, Ireland