Viaskin® Peanut (DBV712) Expanded Access Protocol

Sponsor

DBV Technologies (Industry)

Overall Status

No longer available

CT.gov ID

NCT04371627

Collaborator

(none)

Study Details

Study Description

Brief Summary

This is an open label expanded access program for male and female patients ≥ 4 years old.

Condition or Disease	Intervention/Treatment	Phase
Peanut Allergy	Drug: Viaskin Peanut

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.

Study Design

Study Type:

Expanded Access

Official Title:

Viaskin® Peanut (DBV712) Expanded Access Protocol in Peanut-Allergic Children

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 12 Years

Sexes Eligible for Study:

All

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.