E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with a documented clinically relevant history of moderate to severe birch pollen induced allergic rhinoconjunctivitis (with or without asthma) with symptoms despite having received symptomatic medication. |
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E.1.1.1 | Medical condition in easily understood language |
Subjects with hay fever caused by allergy to birch pollen with symptoms despite taking symptomatic medication. |
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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 identify an optimal dose interval with respect to efficacy and safety for the ALK tree AIT in adults and adolescents with moderate to severe birch pollen induced allergic rhinoconjunctivitis. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the quality of life related to rhinoconjunctivitis during treatment with the ALK tree AIT.
To investigate the immunological response to the ALK tree AIT |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or females aged 12-65 (adolescents ages 12 - <18 years will only be recruited in selected countries).
Subjectcs with a documented clinical relevant history of moderate to severe birch pollen induced allergic rhinoconjunctivitis (with or without asthma) with symptoms despite having received symptomatic medication.
Subjects with a minimum level of birch pollen allergic rhinoconjunctivitis symptoms.
Presence of one or more of the following ARIA quality of life items during the previous birch pollen season: a. Sleep disturbance, b. Impairment of daily activities, leisure and/or sport, c. Impairment of school or work, d. Troublesome symptoms
A positive SPT response (wheal diameter ≥ 3 mm larger than the negative control to Betula verrucosa)
Positive specific IgE against Bet v1 (≥ IgE Class 2, ≥0.70 kU/L) at screening. |
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E.4 | Principal exclusion criteria |
A clinically relevant history of perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed.
A clinical history of uncontrolled asthma within 3 month prior to randomisation
Reduced lung function, defined as FEV-1 < 70% of predicted value after adequate pharmacological treatment.
Previous treatment with immunotherapy with birch pollen allergen - or a cross-reacting allergen such as hazel or alder. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the avarage rhinoconjunctivitis daily symptom score during the birch pollen season, calculated for each subject as the sum of the rhinoconjunctivitis daily symptom score during the birch pollen season divided by the number of days with diary records in the birch pollen season. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
By the end of trial - there are no interim analyses planned. |
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E.5.2 | Secondary end point(s) |
The secondary efficacy endpoints comprises of:
The average rhinoconjunctivitis daily medication score during the birch pollen season calculated for each subject as the sum of rhinoconjunctivitis daily symptom score during the birch pollen season divided by the number of days with diary records in the birch pollen season.
The combined rhinoconjunctivitis symptom and medication score during the entire birch pollen season.
The average rhinoconjunctivitis daily symptom score, average rhinoconjunctivitis daily medication score during the entire tree pollen season. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
By the end of trial - there are no interim analyses planned. |
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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 | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 7 |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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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End of trial is defined as data base closure |
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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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |