Peanut-allergy
Conditions
Interventions
This study will be conducted in an *open-label* manner. This means that in the
EPOPEX study, the treatment and the dose that your child will receive are
known. All children in EPOPEX will receive th
Sponsors
/
Eligibility
Age
No minimum to 11 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following endpoints will be explored for the assessment of the sustained clinical benefit of Viaskin Peanut 250 µg after 1, 2 and 3 years of treatment in each group (VP+VP group, Placebo+VP group) and overall: • Proportion of subjects reaching an ED >=1000 mg; • Proportion of treatment responders, using the treatment response definition of the EPITOPE study, i.e., a subject is defined as a treatment responder if: o The baseline ED was >10 mg peanut protein and the ED is >=1000 mg peanut protein at the post-baseline DBPCFCs or; o The baseline ED was =300 mg peanut protein at the post-baseline DBPCFCs. For the VP+VP group, the baseline ED is defined as the ED reached at the EPITOPE study entry. For the Placebo+VP group, the baseline ED is defined as the latest, valid ED in the EPITOPE study (i.e., Month 12). • Proportion of subjects reaching a cumulative dose of at least 1444 mg peanut protein at the post-baseline DBPCFCs; • Proportion of subjects reaching a cumulative dose of at least 3444 mg peanut protein at the post-baseline DBPCFCs; • Proportion of subjects unresponsive (i.e., showing no symptoms leading to stopping the DBPCFC) to the highest dose of peanut protein (i.e. 2000 mg), which is the percentage of subjects who pass the post-baseline DBPCFCs; • Mean and median CRD of peanut protein; • Mean and median ED of peanut protein. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following safety endpoints will be analyzed: • Adverse Events and Treatment-emergent adverse events (TEAEs) by System Organ Class (SOC) and Preferred Term (PT); • Treatment-emergent adverse events by maximum severity and by maximum duration and relatedness to the IP; • Serious adverse events (SAEs) by SOC and PTs, maximum severity and relatedness to the IP; • Treatment-emergent adverse events leading to treatment discontinuation; • Local adverse events of special interest (AESIs) (i.e., reactions at patch sites potentially leading to skin barrier disruption) and systemic AESIs (i.e., anaphylaxis, or systemic hypersensitivity reactions leading to epinephrine intake), whatever the causal relationship to the IP; • Incidence, duration and maximum severity of local cutaneous reactions as assessed by the subjects; • Incidence and severity of local cutaneous reactions as assessed by the Investigator; • Laboratory data, physical examinations and vital signs; The following study procedure safety criteria will be assessed over 3 years of treatment: • Symptoms elicited during the DBPCFCs by severity; • Severity of symptoms score during the DBPCFCs; • Serious AEs elicited during the DBPCFCs. The safety endpoints will be evaluated in the overall Safety population using the rescheduling rules and by treatment group (VP+VP / Placebo+VP). The following exploratory endpoints will be evaluated over 3 years of treatment in each group (VP+VP group, Placebo+VP group) and overall using the rescheduling rules: • Total IgE, peanut-specific IgE and IgG4 levels and levels of IgE and IgG4 specific to peanut protein components (Ara h 1, Ara h 2, Ara h 3); • Peanut SPT average wheal diameters; • Description of the quality of life (QoL) questionnaires (FAQLQ/FAIM/ EQ-5D-5L) data and QoL scores; • Enumeration and characterization of reactions triggered by accidental consumption of peanut and analysis of *risk-taking behavior* of subjects (voluntary peanut con | — |
Countries
Netherlands
Outcome results
None listed