ClinicalTrials.gg
AvailableNCT05424731Updated Jan 15, 2026

Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children

An expanded access record providing DBV712 250 mcg in Peanut Allergy, sponsored by DBV Technologies. Available at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-15.

Sponsored by DBV Technologies · Expanded access

Study type
Expanded access
Access type
Intermediate-size population
Ages
2 Years to 17 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Peanut Allergy

Keywords

  • EPIT
  • Epicutaneous
  • Immunotherapy
  • Viaskin
03

In context

Peanut Hypersensitivity

166 studies on the registry are indexed under Peanut Hypersensitivity; 27 are open to participants now.

Browse Peanut Hypersensitivity studies →

Lead sponsor

DBV Technologies is the lead sponsor of 16 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 to of the DBV712 patches.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • Combination productDBV712 250 mcg

    Daily epicutaneous delivery.

    Also known as: Viaskin® Peanut

06

Where to request access

1 of 1 sites recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT05424731
Lead sponsor
DBV Technologies
Responsible party
Sponsor
First posted
Jun 21, 2022
Last update
Jan 15, 2026

Study contacts

Anne B Cropp, Pharm. D.
Contact
DBV712.eap@earlyaccesscare.com
1-888-441-793 ext. 125
Laurie Reynolds, BS
Contact
DBV712.eap@earlyaccesscare.com
1-888-441-793 ext. 125
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

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Discussion

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