Back to resultsViaskin® Peanut (DBV712) Expanded Access Protocol
Primary Purpose
Peanut Allergy
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Viaskin Peanut
Sponsored by
About this trial
This is an expanded access trial for Peanut Allergy focused on measuring Peanut allergy, EPIT, Epicutaneous, Immunotherapy, Viaskin®
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04371627
Brief Title
Viaskin® Peanut (DBV712) Expanded Access Protocol
Official Title
Viaskin® Peanut (DBV712) Expanded Access Protocol in Peanut-Allergic Children
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
No longer available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DBV Technologies
4. Oversight
5. Study Description
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peanut Allergy
Keywords
Peanut allergy, EPIT, Epicutaneous, Immunotherapy, Viaskin®
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Viaskin Peanut
Other Intervention Name(s)
DBV712
Intervention Description
Daily epicutaneous delivery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
Viaskin® Peanut (DBV712) Expanded Access Protocol
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