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OpenTrials
Completed

NCT Number: NCT03859700

Follow-up of the EPITOPE Study to Evaluate Long-term Efficacy and Safety of DBV712 in Young Children

Open-label, follow-up study for subjects who completed the EPITOPE study.

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Key information

Conditions

Peanut Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nut and Peanut Hypersensitivity Peanut Hypersensitivity

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Banner University Medical Center Tucson, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • completion of the EPITOPE study

Exclusion criteria

  • Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back or arms with no intact zones to apply the Viaskin patches.
  • Diagnosis of asthma that evolved to severe, unstable or uncontrolled asthma

Treatment and study plan

DBV712 250 mcg

Biological

DBV712 250 mcg, once daily

Primary outcomes

  1. Proportion of subjects reaching an ED ≥1000 mg

    Time frame: 12 months

  2. Proportion of subjects reaching an ED ≥1000 mg

    Time frame: 24 months

  3. Proportion of subjects reaching an ED ≥1000 mg

    Time frame: 36 months

Secondary outcomes

  1. Adverse Events (AEs), Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)

    Time frame: Throughout the study during 36 months

Sponsors and collaborators

Lead sponsor

DBV Technologies

Industry

Registry information

Official study title

EPITOPE Open-label Extension Study to Evaluate the Long-term Clinical Benefit and Safety of DBV712 in Peanut-Allergic Children

Acronym: EPOPEX

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Mar 1, 2019
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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