Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children (NCT05424731) | Clinical Trial Compass
AVAILABLENot Applicable
Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children
United States
Plain-language 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.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.