Viaskin® Peanut (DBV712) Expanded Access Protocol

NCT ID: NCT04371627

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Peanut Allergy

Interventions

Viaskin Peanut

Daily epicutaneous delivery

Intervention Type: DRUG

Other Intervention Names

DBV712

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DBV Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

V712-EAP01

Identifier Type: -

Identifier Source: org_study_id