At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 500 enrolled
Drug / intervention
Viaskin Peanut 250mcg +1 morebiological
Likely dose
Viaskin Peanut 250mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Viaskin Peanut 250mcg and Placebo for Peanut Allergy. Completed, enrolled 500 participants across 31 sites in 5 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesAustralia, Canada, Germany, Ireland, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartDec 2015
First PostedDec 2015
Primary CompletionAug 2017
TodayJul 2026
First PostedDec 22, 2015
Enrollment StartDec 1, 2015
Primary CompletionAug 18, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.5 years ago
Interventions
Viaskin Peanut 250mcgbiological
Peanut extract cutaneous patch
Placebobiological
Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract