E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients; children at age 4 years with house dust mite IgE sensitization without allergic disease |
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E.1.1.1 | Medical condition in easily understood language |
In order to prevent the development of allergic diseases in children sensitized to house dust mite a preventive immunotherapy trial will be applied. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
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 induce protective immunomodulation (increase of allergen-specific IgG, IgG4, TGFb, IL10) in children with IgE-sensitization to house dust mite without allergic disease manifestation at the age of 4 years |
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E.2.2 | Secondary objectives of the trial |
a) to prevent the development of new IgE-sensitizations b) to prevent the development of clinical symptoms of allergy |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Children four years of age with sensitization to house dust mite without clinical history of allergic symptoms are eligible for study participation: • age of 4 years • house dust mite sensitization (SPT > 3mm or specific IgE > 0.35 kU/l) • additional sensitization to no maximum 3 inhalant or nutritive allergens in total (6-grass-pollen mix, birch pollen, cladosporium herbarum, alternaria alternata, peanut, cat- and dog dander, hen‘s egg and cow´s milk) • no allergic symptoms from the upper airways and/or eyes during house dust mite exposure (validated by allergen provocation chamber exposure) • other accepted atopic manifestations of the index child are: o IgE to food allergens without present food allergy, exposed to the particular food during the last 12 months, o mild eczema with effective treatment of group 1-2 steroids, o virus-induced asthma/preschool wheeze up to the last 12 months, |
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E.4 | Principal exclusion criteria |
• Perennial upper airway symptoms (rhinorrhea, congestion), • poly-sensitization to airborne and nutritive allergens, ≥ 4 different inhalant allergens (6-grass-pollen mix, birch pollen, cladosporium herbarum, alternaria alternata, peanut, cat- and dog dander, hen‘s egg and cow´s milk), • clinical food allergy with IgE-sensitization, • at randomisation: o severe allergic rhino-conjunctivitis during pre-treatment season, need of systemic steroid, o bronchial asthma, with regular use of inhaled corticosteroids, long-activating bronchiodilators (LABA) and/or anti-leukotriene receptor agonists, o before or during treatment period - eczema, regular use of group 2 steroids >2 months the last 12 months, o severe allergic disease and or severe other disease, o other immune disease or children on immune regulating medication. • pregnancy or lactation • significant medical conditions, e.g. concomitant liver-, gastrointestinal-, kidney-, cardiovascular-, or pulmonary conditions, auto-immune diseases, hematological disorders or malignant diseases • a history of monoclonal antibody therapy |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy: Induction of immunomodulatory effects (allergen-specific IgG and IgG4 and TGFb and IL10) by house dust mite specific immunotherapy in 4 year old children with house dust mite IgE sensitisation without allergic disease |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the primary end point parameter will be assessed: a) at treatment start t0 b) one and 2 years after treatment start t12 and t24 c) 2 years after treatment stop t48 |
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E.5.2 | Secondary end point(s) |
Secondary Efficacy: a) development of new IgE-sensitizations b) development of clinical symptoms of allergy |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Evaluation of the secondary end point parameter will be assessed: a) at treatment start t0 b) one and 2 years after treatment start t12 and t24 c) 2 years after treatment stop t48 |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
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 | No |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |