Viaskin® Peanut (DBV712) Expanded Access Protocol

NCT04371627 | Unknown

• 1 other identifier: V712-EAP01
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Peanut Allergy

Keywords

Peanut allergy; EPIT; Epicutaneous; Immunotherapy; Viaskin®

Interventions

Viaskin Peanut DRUG

Daily epicutaneous delivery

Also known as: DBV712

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• Male or female ≥ 4 years of age
• Prior participation in a Viaskin® Peanut REALISE or PEOPLE clinical study for peanut-allergic patients

You may not qualify if:

• 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.

Sponsors & Collaborators

• DBV Technologies: lead

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Last Updated: May 28, 2021

Record last verified: 2021-05