Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children
NCT ID: NCT05424731
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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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
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Interventions
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DBV712 250 mcg
Daily epicutaneous delivery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
2 Years
17 Years
ALL
No
Sponsors
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DBV Technologies
INDUSTRY
Responsible Party
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Locations
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Early Access Care, LLC
Madison, Connecticut, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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V712-EAP02
Identifier Type: -
Identifier Source: org_study_id
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