drugset / Trial / NCT01955109

Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children

NCT01955109 ↗

Phase 2 Completed 171 enrolled DBV Technologies
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-09
Primary completion
2016-09
Completion
2016-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Viaskin Peanut Protein / enzyme biologic 250 ug Other

Indications