E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034202 |
E.1.2 | Term | Peanut allergy |
E.1.2 | System Organ Class | 100000004870 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Canada |
Germany |
Ireland |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |