Peanut AllergyNCT05424731
Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children
A study testing DBV712 250 mcg in people with Peanut Allergy, run by DBV Technologies at 1 site in United States.
Trial summary
This is an open label expanded access program for male and female patients 2 years or older, to provide continued desensitization treatment with DBV712 250 mcg. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Peanut Allergy
- What is being tested?
- DBV712 250 mcg
- How many people
- Not given
- Where
- 1 siteUnited States
- 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 2 to 17 years
- All sexes
- Child
Who may be able to join
- Participation is by invitation, limited to individuals completing clinical study V712-303 (PEOPLE), previous Expanded Access Program or a DBV clinical study initiated after 31-Jan-2022
- Male and females; ages ≥ 2 years old at Visit 1 or current or prior studies.
- Negative urine pregnancy test for female participants of childbearing potential.
Who cannot join
- Early withdrawal from a DBV712 clinical study.
- History of non-compliance during the primary clinical study or unable to follow the protocol requirements.
- Generalized dermatologic disease extending widely on the skin.
- History of intolerance or who developed hypersensitivity to excipients of the DBV712 patches.
Trial locations and contacts
1 site in 1 country.
United States1 site
- Available
Early Access Care, LLC
Madison, Connecticut, 06443
Anne B Cropp, Pharm. D., 888-441-7938 ext. 125, DBV712.eap@earlyaccesscare.com
Laurie Reynolds, 06443, 1-888-441-7938 ext. 125, DBV712.eap@earlyaccesscare.com
About this study
Official title: Viaskin® Peanut (DBV712) Compassionate Use in Peanut-allergic Children Previously Enrolled in a DBV712 Clinical Study
This is an open label expanded access program for male and female patients 2 years or older, to provide continued desensitization treatment with DBV712 250 mcg.
Read the detailed description
This study is an open-label Expanded Access Protocol to provide continued treatment with DBV712 for individuals completing a DBV clinical study. Participation is by invitation according to the inclusion criteria.
For individuals who have received DBV712 for longer than one year prior to entry into this protocol, where treatment allocation is unblinded, safety assessment and resupply of DBV712 will occur at 6-month intervals. There will be no other scheduled study visits. For individuals who have been on blinded treatment, a safety assessment will be conducted at Months 1 and 3. Visits for safety assessment and resupply of DBV712 will occur at 3-month intervals during the first 12 months. After a year, visits will occur at 6-month intervals. DBV712 will be supplied to participants at study visits to suffice until the next visit. For individuals who have been on blinded treatment, or off DBV712 treatment for more than 14 days prior to entry into this protocol, dosing consists of approximately 6 hours for the first week, 12 hours for the second week, then once daily, at approximately the same time of day.
Treatment with DBV712 will continue until, in the clinical judgement of the treating physician, the participant is no longer benefiting from continuation of the treatment, DBV712 is approved and available by prescription, or the study is terminated.
- Conditions
- Peanut Allergy
- Being tested
- DBV712 250 mcg
- Keywords
- 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.
DBV712 250 mcgCombination product
Also called Viaskin® Peanut
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 posted21 Jun 2022
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
- NCT05424731
- Sponsor's protocol ID
- V712-EAP02
- Status last verified
- Jan 2026
- First submitted
- 14 Jun 2022
- Last updated
- 15 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viaskin® Peanut (DBV712) Compassionate Use in Peanut-allergic Children Previously Enrolled in a DBV712 Clinical Study
- ClinicalTrials.gov ID
- NCT05424731
- Acronym / sponsor ID
- V712-EAP02
- Conditions
- Peanut Allergy
- Keywords
- EPIT, Epicutaneous, Immunotherapy, Viaskin
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- DBV TechnologiesIndustry (pharma, biotech, devices)
- First posted
- 21 Jun 2022 (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 2 years or older, to provide continued desensitization treatment with DBV712 250 mcg.
Detailed description
This study is an open-label Expanded Access Protocol to provide continued treatment with DBV712 for individuals completing a DBV clinical study. Participation is by invitation according to the inclusion criteria.
For individuals who have received DBV712 for longer than one year prior to entry into this protocol, where treatment allocation is unblinded, safety assessment and resupply of DBV712 will occur at 6-month intervals. There will be no other scheduled study visits. For individuals who have been on blinded treatment, a safety assessment will be conducted at Months 1 and 3. Visits for safety assessment and resupply of DBV712 will occur at 3-month intervals during the first 12 months. After a year, visits will occur at 6-month intervals. DBV712 will be supplied to participants at study visits to suffice until the next visit. For individuals who have been on blinded treatment, or off DBV712 treatment for more than 14 days prior to entry into this protocol, dosing consists of approximately 6 hours for the first week, 12 hours for the second week, then once daily, at approximately the same time of day.
Treatment with DBV712 will continue until, in the clinical judgement of the treating physician, the participant is no longer benefiting from continuation of the treatment, DBV712 is approved and available by prescription, or the study is terminated.
Study design
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participation is by invitation, limited to individuals completing clinical study V712-303 (PEOPLE), previous Expanded Access Program or a DBV clinical study initiated after 31-Jan-2022
- Male and females; ages ≥ 2 years old at Visit 1 or current or prior studies.
- Negative urine pregnancy test for female participants of childbearing potential.
Key exclusion criteria (4 listed)
- Early withdrawal from a DBV712 clinical study.
- History of non-compliance during the primary clinical study or unable to follow the protocol requirements.
- Generalized dermatologic disease extending widely on the skin.
- History of intolerance or who developed hypersensitivity to excipients of the DBV712 patches.
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 |
|---|---|---|
| DBV712 250 mcgAlso: Viaskin® PeanutDaily epicutaneous delivery. | Combination product | – |
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 15 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBV712 250 mcg in people with Peanut Allergy, run by DBV Technologies at 1 site in United States.
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 3 inclusion and 4 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Anne B Cropp, Pharm. D. (1-888-441-793 ext. 125, DBV712.eap@earlyaccesscare.com), or a site near the patient. 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 15 Jan 2026.