E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Tree pollen induced allergic rhinitis and/or conjuctivitis. |
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E.1.1.1 | Medical condition in easily understood language |
Rhinitis and/or conjuctivitis induced due to allergy to tree pollen. |
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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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001726 |
E.1.2 | Term | Allergic rhinitis due to pollen |
E.1.2 | System Organ Class | 100000004870 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001709 |
E.1.2 | Term | Allergic conjunctivitis |
E.1.2 | System Organ Class | 100000004853 |
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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 compare the efficacy of the SQ tree SLIT-tablet to placebo in the treatment of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch and trees belonging to the birch homologous group in children and adolescents (5 through 17 years of age) based on the average allergic rhinoconjunctivitis daily total combined score (average TCS) during the birch pollen season (BPS) |
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E.2.2 | Secondary objectives of the trial |
Key secondary objectives: To compare the efficacy of the SQ tree SLIT-tablet to placebo based on: •The average TCS during the tree pollen season (TPS) •The average allergic rhinoconjunctivitis daily symptom score (average DSS) during the BPS and TPS •The average allergic rhinoconjunctivitis daily medication score (average DMS) during the BPS and TPS Secondary objectives: •To compare the safety and tolerability of the SQ tree SLIT-tablet to placebo •To compare the efficacy of the SQ tree SLIT-tablet to placebo using additional endpoints based on daily allergic rhinoconjunctivitis symptoms and rescue medication use •To compare the efficacy of the SQ tree SLIT-tablet to placebo based on assessments of quality of life •To compare the efficacy of the SQ tree SLIT-tablet to placebo based on patient treatment satisfaction •To compare the effect of the SQ tree SLIT-tablet to placebo on immunological parameters to birch, alder, hazel and oak pollen
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects are eligible to be included in the trial only if all the following criteria apply: •Male or female of any race/ethnicity aged ≥4 to <18 years on the day informed consent is obtained from the parent/caregiver; the subject must be ≥5 to <18 years old at the randomisation visit •A documented, physician diagnosed, clinically relevant history of moderate to severe AR/C induced by birch pollen (with or without asthma) despite having received treatment with symptom-relieving medication during at least 1 previous tree pollen season for ages 4 through 6 years at screening or at least 2 previous tree pollen seasons for ages 7 through 17 years at screening •Positive skin prick test (SPT) to Betula verrucosa at screening •Positive specific IgE to Bet v at screening •Presence of 1 or more of the following Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to AR/C during the previous BPS: a.Sleep disturbance b.Impairment of daily activities, leisure and/or sport c.Impairment of school or work d.Troublesome symptoms
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E.4 | Principal exclusion criteria |
Subjects are excluded from the trial if any of the following criteria apply: •A clinically relevant history of symptomatic seasonal AR/C caused by an allergen source, other than tree pollen from the birch homologous group, with a season overlapping the TPS •A clinically relevant history of symptomatic perennial AR/C caused by an allergen source such as animal hair and dander to which the subject is exposed during the TPS •Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation •Reduced lung function at randomisation defined as forced expiratory volume in 1 second (FEV1) <70% of predicted value. For subjects with asthma, this is assessed on subject’s usual asthma medication following at least a 6-hour wash-out of SABA. This criterion does not need to be fulfilled if the subject is <7 years old, cannot perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma •Ongoing treatment with any allergy immunotherapy product •Severe chronic oral inflammation •A diagnosis of eosinophilic oesophagitis •A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern •Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
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E.5 End points |
E.5.1 | Primary end point(s) |
Average TCS during the BPS |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During the Birch Pollen Season (BPS) |
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E.5.2 | Secondary end point(s) |
•Average TCS during the TPS •Average DSS during the BPS •Average DSS during the TPS •Average DMS during the BPS •Average DMS during the TPS
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
During either Birch Pollen Season (BPS) or Tree Pollen Season (TPS), respectively. |
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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 | 22 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 68 |
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 |
Canada |
Austria |
Lithuania |
Poland |
Netherlands |
Germany |
Belgium |
Denmark |
Hungary |
Russian Federation |
Slovakia |
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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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Date of the last follow-up phone visit (TC4) for the last subject in 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 | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 17 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |