Safety and Efficacy Study of Viaskin Peanut in Peanut-allergic Young Children 1-3 Years of Age

  • STATUS
    Recruiting
  • End date
    Feb 28, 2022
  • participants needed
    331
  • sponsor
    DBV Technologies
Updated on 1 November 2020
Investigator
Lara Ford, MD
Primary Contact
The Children's Hospital at Westmead (7.7 mi away) Contact
+50 other location
a 12

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).

Details
Treatment Placebo, Viaskin Peanut 250 mcg, Viaskin Peanut 100 mcg
Clinical Study IdentifierNCT03211247
SponsorDBV Technologies
Last Modified on1 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 1 yrs and 3 yrs?
Gender: Male or Female
Do you have peanut allergy?
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

Exclusion Criteria

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

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Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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