NCT05424731

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

First QC Date

June 14, 2022

Last Update Submit

January 14, 2026

Conditions

Peanut Allergy

Keywords

EPITEpicutaneousImmunotherapyViaskin

Interventions

DBV712 250 mcgCOMBINATION_PRODUCT

Daily epicutaneous delivery.

Also known as: Viaskin® Peanut

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Early Access Care, LLC

Madison, Connecticut, 06443, United States

AVAILABLE

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityFood HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Anne B Cropp, Pharm. D.

CONTACT

1-888-441-793DBV712.eap@earlyaccesscare.com

Laurie Reynolds, BS

CONTACT

1-888-441-793DBV712.eap@earlyaccesscare.com

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2022

First Posted

June 21, 2022

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

US(1)