Peanut Allergy Treatment Using Viaskin® Patch – Phase II

Viaskin Peanut Efficacy and Safety for Adults and Children With Peanut Allergy (VIPES)

Protocol Description

This international multi-center study is investigating whether the Viaskin® Peanut drug patch can help people who are allergic to peanuts by desensitizing them and possibly protecting them from severe reactions in the case of accidental ingestion of peanuts. In the U.S., peanut hypersensitivity prevalence is estimated to be as high as 1 percent, and the only present treatment is strict peanut avoidance.

Study Level: Phase II

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting participants of both genders, ages 12 through 55, who have been diagnosed with a peanut allergy. (In its entirety, the study is investigating participants ranging in age from 6 through 55, however the enrollment group for those aged 6 through 11 is full.)
Males: Ages 12 through 55
Females: Ages 12 through 55

Participation begins with a 4-week screening period to assess eligibility and the degree of allergy in candidates. This is followed by 52 weeks of daily use of the study drug via patch worn on the upper arm, and a final visit 2 weeks after the last use of the patch. Participants will be randomly assigned to receive Viaskin Peanut patches in one of three dose levels or containing a placebo. Except for the placebo, the patches contain a small amount of a dry extract of peanut protein. Participant reactions to the therapy will be closely monitored though visits with the study team throughout the testing period. Participants must keep a diary concerning daily usage of the patch and potential side effects, and visits will include bloodwork, allergen skin tests, and pulmonary function tests.
Visits: 12
Duration: 1 year and 6 weeks

Status: Enrollment Closed

Source(s) of Support
DBV Technologies

Additional Resources
Study Description at National Institutes of Health

Primary Investigator(s)

Todd D. Green, MD, FAAAAI

Contact Information

For more information about the study, please contact:
Elizabeth Hartigan, MPH, RN

Last Update
June 10, 2013
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Last Update
June 10, 2013