Viaskin® Peanut (DBV712) Expanded Access Protocol


Study First Submitted Date 2020-04-29
Study First Posted Date 2020-05-01
Last Update Posted Date 2021-05-28
Verification Month Year May 2021
Verification Date 2021-05-31
Last Update Posted Date 2021-05-28

Detailed Descriptions

Sequence: 20840529
Description 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.


Sequence: 52475816
Name Peanut Allergy
Downcase Name peanut allergy

Id Information

Sequence: 40376947
Id Source org_study_id
Id Value V712-EAP01


Sequence: 52785880
Intervention Type Drug
Name Viaskin Peanut
Description Daily epicutaneous delivery


Sequence: 80282368 Sequence: 80282369 Sequence: 80282370 Sequence: 80282371 Sequence: 80282372
Name Peanut allergy Name EPIT Name Epicutaneous Name Immunotherapy Name Viaskin®
Downcase Name peanut allergy Downcase Name epit Downcase Name epicutaneous Downcase Name immunotherapy Downcase Name viaskin®

Browse Conditions

Sequence: 194651025 Sequence: 194651026 Sequence: 194651027 Sequence: 194651028 Sequence: 194651029 Sequence: 194651030
Mesh Term Peanut Hypersensitivity Mesh Term Hypersensitivity Mesh Term Immune System Diseases Mesh Term Nut and Peanut Hypersensitivity Mesh Term Food Hypersensitivity Mesh Term Hypersensitivity, Immediate
Downcase Mesh Term peanut hypersensitivity Downcase Mesh Term hypersensitivity Downcase Mesh Term immune system diseases Downcase Mesh Term nut and peanut hypersensitivity Downcase Mesh Term food hypersensitivity Downcase Mesh Term hypersensitivity, immediate
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor


Sequence: 48602408
Agency Class INDUSTRY
Lead Or Collaborator lead
Name DBV Technologies


Sequence: 30940150
Gender All
Minimum Age 4 Years
Maximum Age 12 Years
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.
Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254276938
Registered In Calendar Year 2020
Were Results Reported False
Has Single Facility False
Minimum Age Num 4
Maximum Age Num 12
Minimum Age Unit Years
Maximum Age Unit Years

Intervention Other Names

Sequence: 26824700
Intervention Id 52785880
Name DBV712

Responsible Parties

Sequence: 29052497
Responsible Party Type Sponsor