Peanut Allergy MedDRA version: 19.0 Level: LLT Classification code 10034202 Term: Peanut allergy System Organ Class: 100000004870
Conditions
Interventions
Product Code: Viaskin Peanut
Pharmaceutical Form: Cutaneous patch
Current Sponsor code: Peanut Protein Extract
Concentration unit: % percent
Concentration type: range
Concentration number: 75.3-113.0
Sponsors
DBV Technologies
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female children aged 4 through 11 years at Visit 1 - Physician-diagnosed peanut allergy or children with a well documented medical history of IgE-mediated reactions after ingestion of peanut and currently following a strict peanut-free diet. Are the trial subjects under 18? yes Number of subjects for this age range: 330 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of severe anaphylaxis to peanut with any of the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence) - Severe reaction during the entry/screening DBPCFC (defined as need for intubation, hypotension persisting after epinephrine administration, and/or the need for =3 doses of epinephrine), or if they have an objective IgE-mediated reaction to the placebo formula during the entry/screening DBPCFC.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of Viaskin Peanut to induce desensitization to peanut in peanut-allergic subjects 4 through 11 years of age after a 12 month treatment period by EPicutaneous ImmunoTherapy (EPIT).;Secondary Objective: Not applicable;Primary end point(s): Percentage of treatment responders in the active Viaskin Peanut 250 µg group compared to the placebo group. A subject is defined as a treatment responder if: - The initial eliciting dose(ED) was >10 mg peanut protein and the ED is =1,000 mg peanut protein at the post treatment double-blind placebo controlled food challenge (DBPCFC), or - The initial ED was =10 mg peanut protein and the ED is =300 mg peanut protein at the post-treatment DBPCFC.;Timepoint(s) of evaluation of this end point: Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of treatment responders in the active Viaskin Peanut 250 µg group compared to the placebo group in each of the 2 screening eliciting dose (ED) strata. - Percentage of treatment responders in the active Viaskin Peanut 250 µg group compared to the placebo group in each of the 2 age subgroups: 4 to 5 years-old; 6 to 11 years-old. - Mean and median cumulative reactive dose of peanut protein and change from baseline in the active Viaskin Peanut 250 µg group versus the placebo group; - Mean and median ED of peanut protein and change from baseline in the active Viaskin Peanut 250 µg group versus the placebo group; - Percentage of subjects responsive (those showing objective symptoms leading to DBPCFC stop) to a cumulative dose =1,444 mg peanut protein at the post treatment DBPCFC in the active Viaskin Peanut 250 µg group versus the placebo group; - Percentage of subjects unresponsive (those showing no objective symptoms leading to DBPCFC stop) to a cumulative dose =1,444 mg peanut protein at the post-treatment DBPCFC in the active Viaskin Peanut 250 µg group versus the placebo group; - Percentage of subjects unresponsive (those showing no objective symptoms leading to DBPCFC stop) to the highest dose of peanut protein, which is the percentage of subjects who pass the post treatment DBPCFC in the active Viaskin Peanut 250 µg group versus the placebo group.;Timepoint(s) of evaluation of this end point: Month 12 | — |
Countries
Australia, Canada, Germany, Ireland, United States
Contacts
Public ContactClinical Trials Information
DBV Technologies
Outcome results
None listed