Peanut AllergyNCT04371627
Viaskin® Peanut (DBV712) Expanded Access Protocol
A study testing Viaskin Peanut in people with Peanut Allergy, run by DBV Technologies.
Trial summary
This is an open label expanded access program for male and female patients ≥ 4 years old. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- Viaskin Peanut
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Child
Who may be able to join
- Male or female ≥ 4 years of age
- Prior participation in a Viaskin® Peanut REALISE or PEOPLE clinical study for peanut-allergic patients
Who cannot join
- 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.
About this study
Official title: Viaskin® Peanut (DBV712) Expanded Access Protocol in Peanut-Allergic Children
This is an open label expanded access program for male and female patients ≥ 4 years old.
Read the 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
- Being tested
- Viaskin Peanut
- Keywords
- Peanut allergy, EPIT, Epicutaneous, Immunotherapy, Viaskin®
- Medical subject headings
- Peanut Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viaskin PeanutDrug
Also called DBV712
Daily epicutaneous delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peanut AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- DBV Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371627
- Sponsor's protocol ID
- V712-EAP01
- Status last verified
- May 2021
- First submitted
- 29 Apr 2020
- Last updated
- 28 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viaskin® Peanut (DBV712) Expanded Access Protocol in Peanut-Allergic Children
- ClinicalTrials.gov ID
- NCT04371627
- Acronym / sponsor ID
- V712-EAP01
- Conditions
- Peanut Allergy
- Keywords
- Peanut allergy, EPIT, Epicutaneous, Immunotherapy, Viaskin®
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- DBV TechnologiesIndustry (pharma, biotech, devices)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male or female ≥ 4 years of age
- Prior participation in a Viaskin® Peanut REALISE or PEOPLE clinical study for peanut-allergic patients
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viaskin PeanutAlso: DBV712Daily epicutaneous delivery | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Viaskin Peanut in people with Peanut Allergy, run by DBV Technologies.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.