Current Environment:

Summary

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.

Conditions

Peanut Allergy

Recruitment Status

UNKNOWN

Eligibility Criteria

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.

Intervention

Intervention Type

Intervention Name

DRUG

Viaskin Peanut 250µg

Phase

PHASE3

Gender

ALL

Min Age

N/A

Max Age

N/A

Download Date

2020-12-02

Principal Investigator

N/A

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team:

Follow-up of the PEPITES Study to Evaluate Long-term Efficacy and Safety of Viaskin Peanut in Children NCT03013517