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 | 20.1 |
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 clinical benefit of Viaskin® Peanut 250 μg after up to 36 months of EPIT to induce / maintain desensitization to peanut in peanut-allergic children.
-To explore the clinical benefit of Viaskin®Peanut 250 µg after up to 5 years of EPIT to induce/maintain desensitization to peanut in peanut allergic children.
- To assess the sustainability of unresponsiveness to peanut (eliciting dose [ED] ≥1,000 mg) after 2 months of treatment discontinuation
- To evaluate the safety of long-term treatment with Viaskin® Peanut 250 μg in peanutallergic children. |
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E.2.2 | Secondary objectives of the trial |
To explore novel biomarkers that may be predictive of the clinical trial response |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed informed consent from parent(s)/guardian(s) of the child and child’s assent for children ≥7 years or as per country-specific regulations or laws. - Subjects who completed the PEPITES study, with a mandatory, completed and documented DBPCFC at Month 12 (i.e. both Visit 10 and Visit 11 performed). |
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E.4 | Principal exclusion criteria |
- Subjects who developed a severe anaphylactic reaction during the PEPITES 12-Month DBPCFC (at V10 or V11) - Any clinically significant disease which in the judgment of the Investigator may preclude safe participation or strict compliance with the protocol procedures. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- The main endpoint for assessing peanut desensitization is the percentage of subjects reaching an Eliciting Dose (ED) ≥ 1,000 mg after 3 years of active treatment overall in the VP250+VP250 group compared to the percentage after 1 year of active treatment (end of the PEPITES study). - Adverse Events and Treatment-emergent adverse events (TEAEs) by System Organ Class (SOC) and Preferred Terms (PTs) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3 years of active treatment |
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E.5.2 | Secondary end point(s) |
- The percentage of subjects reaching an ED ≥1,000 mg - The cumulative reactive dose (CRD) of peanut protein |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
3, 4 or 5 years of active treatment and 2 months after treatment discontinuation |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
4 years of treatment for subjects in active treatment in PEPITES & 3 years for subjects in placebo |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 22 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |