Viaskin® Peanut (DBV712) Expanded Access Protocol
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ClinicalTrials.gov Identifier: NCT04371627 |
Expanded Access Status :
No longer available
First Posted : May 1, 2020
Last Update Posted : May 28, 2021
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Sponsor:
DBV Technologies
Information provided by (Responsible Party):
DBV Technologies
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Brief Summary:
This is an open label expanded access program for male and female patients ≥ 4 years old.
Condition or disease | Intervention/treatment |
---|---|
Peanut Allergy | Drug: Viaskin Peanut |
This study is an open-label Intermediate-size EAP designed to provide treatment access for eligible Peanut-Allergic Children. This EAP entails visits every three months to assess patient status, safety, and to provide drug supply. Viaskin® Peanut treatment will continue until, in the clinical judgment of the Investigator, the patient is no longer benefiting from continuation of the treatment, the drug becomes approved and available by prescription, or the study is terminated.
Study Type : | Expanded Access |
Expanded Access Type : | Intermediate-size Population |
See clinical trials of the intervention/treatment in this expanded access record. | |
Official Title: | Viaskin® Peanut (DBV712) Expanded Access Protocol in Peanut-Allergic Children |
Resource links provided by the National Library of Medicine

Drug Information available for:
Arachis hypogaea
Intervention Details:
- Drug: Viaskin Peanut
Daily epicutaneous deliveryOther Name: DBV712
Information from the National Library of Medicine

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Ages Eligible for Study: | 4 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Criteria
Inclusion Criteria:
- Male or female ≥ 4 years of age
- Prior participation in a Viaskin® Peanut REALISE or PEOPLE clinical study for peanut-allergic patients
Exclusion Criteria:
- Pregnancy or lactation or planning a pregnancy.
- Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back with no intact zones to apply the Viaskin® patches.
- Patients who developed hypersensitivity to excipients of the Viaskin® patches.
- Received or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy.
- Receiving or planning to receive any other type of immunotherapy to any food (for example, EPIT, OIT, or SLIT or specific oral tolerance induction) or any aeroallergen or venom immunotherapy during their participation in the study.
- Use of cyclosporine or other immunosuppressive agents within 3 months before entering the study. Topical calcineurin inhibitors are permitted.
- A history of important non-compliance during the REALISE or PEOPLE studies. Important non-compliance includes patients not applying the patches for 60 or more days in total and/or for 30 or more consecutive days during the REALISE or PEOPLE studies.
No Contacts or Locations Provided
Responsible Party: | DBV Technologies |
ClinicalTrials.gov Identifier: | NCT04371627 |
Other Study ID Numbers: |
V712-EAP01 |
First Posted: | May 1, 2020 Key Record Dates |
Last Update Posted: | May 28, 2021 |
Last Verified: | May 2021 |
Keywords provided by DBV Technologies:
Peanut allergy EPIT Epicutaneous Immunotherapy Viaskin® |
Additional relevant MeSH terms:
Peanut Hypersensitivity Hypersensitivity Immune System Diseases |
Nut and Peanut Hypersensitivity Food Hypersensitivity Hypersensitivity, Immediate |