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Viaskin® Peanut (DBV712) Expanded Access Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371627
Expanded Access Status : Available
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
DBV Technologies

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

Condition or disease Intervention/treatment
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.

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Viaskin® Peanut (DBV712) Expanded Access Protocol in Peanut-Allergic Children

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Viaskin Peanut
    Daily epicutaneous delivery
    Other Name: DBV712

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371627


Contacts
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Contact: Anne Cropp 203-441-7938 dbvtechnologies.eap@earlyaccesscare.com

Sponsors and Collaborators
DBV Technologies
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Responsible Party: DBV Technologies
ClinicalTrials.gov Identifier: NCT04371627    
Other Study ID Numbers: V712-EAP01
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Keywords provided by DBV Technologies:
Peanut allergy
EPIT
Epicutaneous
Immunotherapy
Viaskin®
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate