Studies
| 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. |
Conditions
| Sequence: | 52475816 |
| Name | Peanut Allergy |
| Downcase Name | peanut allergy |
Id Information
| Sequence: | 40376947 |
| Id Source | org_study_id |
| Id Value | V712-EAP01 |
Interventions
| Sequence: | 52785880 |
| Intervention Type | Drug |
| Name | Viaskin Peanut |
| Description | Daily epicutaneous delivery |
Keywords
| 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 |
Sponsors
| Sequence: | 48602408 |
| Agency Class | INDUSTRY |
| Lead Or Collaborator | lead |
| Name | DBV Technologies |
Eligibilities
| 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 |