CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 171 enrolled
Drug / intervention
Viaskin Peanut 250 mcgbiological
Likely dose
Viaskin Peanut 250 mcgfrom 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.

Search/NCT01955109
NCT01955109Phase 2Completed
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Open-label Follow-up Study of the VIPES Study to Evaluate Long-term Efficacy and Safety of the Viaskin Peanut

DBV Technologies·interventional·Posted Oct 7, 2013·Updated Jun 30, 2022

In Brief

A Phase 2 clinical trial evaluating Viaskin Peanut 250 mcg for Peanut Allergy. Completed, enrolled 171 participants across 22 sites in 4 countries.

Detailed Summary

The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: * To assess the efficacy of Viaskin Peanut after up to 36 months of treatment. * To evaluate the safety of long-term treatment with Viaskin Peanut. * To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeanut Allergy
CountriesCanada, France, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 7, 2013
Enrollment StartSep 1, 2013
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 12.7 years ago

Interventions

Viaskin Peanut 250 mcgbiological

Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract