This is an open label expanded access program for male and female patients 2 years orolder, to provide continued desensitization treatment with DBV712 250 mcg.
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.
Combination Product: DBV712 250 mcg
Daily epicutaneous delivery.
Other Name: Viaskin® Peanut
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.
Early Access Care, LLC
Madison, Connecticut, United States
Investigator: Anne B Cropp, Pharm. D.
Contact: 888-441-7938
DBV712.eap@earlyaccesscare.com
Anne B Cropp, Pharm. D.
1-888-441-793 - 125
DBV712.eap@earlyaccesscare.com
Laurie Reynolds, BS
1-888-441-793 - 125
DBV712.eap@earlyaccesscare.com