EPITOPE OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM CLINICAL BENEFIT AND SAFETY OF DBV712 IN PEANUT-ALLERGIC CHILDREN (EPOPEX)

Phase 3

Recruiting

• Conditions: Peanut-allergy; 10001708

• Registration Number: NL-OMON56419
• Lead Sponsor: /

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

All subjects who completed the EPITOPE study up to Visit 11 (inclusive) will be
offered enrollment into the EPOPEX study, provided that all selection criteria
are met. Subjects will be enrolled in this study only if they meet, among
others, the following key inclusion criteria: completion of the EPITOPE study,
with a completed and documented DBPCFC at Month 12 (i.e., both Visit 10 and
Visit 11 performed).

Exclusion Criteria

Subjects will not be enrolled, if they meet, among others, the following
exclusion criteria: development of severe anaphylactic reaction during the
Month 12 DBPCFC (at Visit 10 or Visit 11) in the EPITOPE study requiring a
tracheal intubation or leading to a cardiac arrest and/or to coma; other cases
of severe anaphylaxis will be considered eligible to enter the EPOPEX study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified