DBV712 for Peanut Allergy
(EPOPEX Trial)
Recruiting at 25 trial locations
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: DBV Technologies
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
What is the purpose of this trial?
Open-label, follow-up study for subjects who completed the EPITOPE study.
Eligibility Criteria
This trial is for young children who have completed the EPITOPE study and are dealing with peanut allergies. It's not open to those who've developed severe, unstable asthma or have widespread skin conditions like active eczema that would prevent applying Viaskin patches on clear skin areas.Inclusion Criteria
You have previously participated in the EPITOPE study.
Exclusion Criteria
I have widespread skin conditions like severe eczema, making it impossible to apply patches on my back or arms.
My asthma has become severe and hard to control.
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Open-label Extension
Participants continue to receive DBV712 250mcg to evaluate long-term efficacy and safety
Long-term
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- DBV712
Trial Overview The trial is testing the long-term efficacy and safety of a treatment called DBV712 at a dose of 250 mcg. This is an open-label follow-up study, meaning everyone knows they're getting the treatment and it's a continuation from an earlier phase.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: DBV712 250mcgExperimental Treatment1 Intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
DBV Technologies
Lead Sponsor
Trials
17
Recruited
3,500+
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