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Clinical Trial Finder

Viaskin® Peanut (DBV712) Expanded Access Protocol

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Expanded Access
Eligible Ages 4 Years - 12 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04371627
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 DBV Technologies
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Available
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Peanut Allergy
Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Anne Cropp

dbvtechnologies.eap@earlyaccesscare.com

203-441-7938

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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