Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children



Status:Active, not recruiting
Conditions:Allergy, Allergy, Neurology
Therapuetic Areas:Neurology, Otolaryngology
Healthy:No
Age Range:Any
Updated:2/22/2019
Start Date:January 2017
End Date:February 2020

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Trial Summary
Trial Overview
Inclusion Criteria

Open-label Follow-up Study of the PEPITES Study to Evaluate the Long-term Efficacy and Safety of Viaskin Peanut

This is an open-label, follow-up study for subjects who completed the PEPITES study. Subjects
will be offered enrollment in this follow-up study to receive Viaskin Peanut 250 μg for 2
additional years if previously on active treatment in the PEPITES study, or for 3 years if
previously on placebo in the PEPITES study.


Inclusion Criteria:

- Subjects who completed the PEPITES study.

Exclusion Criteria:

- Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled
generalized active eczema, ichthyosis vulgaris) extending widely on the skin and
especially on the back or arms with no intact zones to apply the Viaskin patches.

- Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma.
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