Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children
ConditionPeanut Allergy
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age2-17
SponsorDBV Technologies
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Treatments tested in this trial
DBV712 250 mcg
Combination productDaily epicutaneous delivery.
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov