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Summary

The study aims to assess the safety and efficacy of Viaskin Peanut to induce desensitization to peanut in peanut-allergic children 1 to 3 years of age after a 12-month treatment by EPicutaneous ImmunoTherapy (EPIT).

Conditions

Peanut Allergy

Recruitment Status

Active, not recruiting

Eligibility Criteria

Key Inclusion Criteria:

Male or female from 1-3 years of age;
Physician-diagnosed peanut allergy;
Peanut-specific IgE level > 0.7 kU/L;
Positive peanut SPT with a largest wheal diameter ≥ 6 mm;
Positive DBPCFC at ≤ 300 mg peanut protein;

Key Exclusion Criteria:

Uncontrolled asthma;
History of severe anaphylaxis to peanut;
Prior immunotherapy to any food or other immunotherapy;
Generalized severe dermatologic disease;

Intervention

Intervention Type

Intervention Name

Biological

Viaskin Peanut 250 mcg

Biological

Viaskin Peanut 100 mcg

Biological

Placebo

Phase

Phase 3

Gender

All

Min Age

1 Year

Max Age

3 Years

Download Date

April 26, 2021

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: