Status:
NO_LONGER_AVAILABLE
Viaskin® Peanut (DBV712) Expanded Access Protocol
Lead Sponsor:
DBV Technologies
Conditions:
Peanut Allergy
Eligibility:
All Genders
4-12 years
Brief Summary
This is an open label expanded access program for male and female patients ≥ 4 years old.
Detailed 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, safet...
Eligibility Criteria
Inclusion
- Male or female ≥ 4 years of age
- Prior participation in a Viaskin® Peanut REALISE or PEOPLE clinical study for peanut-allergic patients
Exclusion
- 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.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04371627
Last Update
May 28 2021
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