E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Long-term follow-up of desensitization by Specific ImmunoTherapy (SIT) received during the trial AN004T in subjects allergic to birch pollen |
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E.1.1.1 | Medical condition in easily understood language |
Long-term follow-up of subjects suffering from birch pollen allergy being treated with the IMP during the trial AN004T in order to see if the desensitization is maintained |
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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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066093 |
E.1.2 | Term | Birch pollen 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 evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the 3rd and 4th following birch pollen seasons
• To evaluate the maintained efficacy of a 2-month pre-seasonal treatment with an AllerT 100-µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the 3rd and 4th following birch pollen seasons
• To compare the effects of a 2-month pre-seasonal treatment with AllerT at maintenance doses of 50 µg and 100 µg during the 2nd to 4th following birch pollen seasons with the effects during the 1st season assessed in Study AN004T. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects satisfying all the following criteria could be included in the trial.
1. Had been randomized in the AN004T trial and had received at least 1 injection
2. Have been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments
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E.4 | Principal exclusion criteria |
Any subject presenting with one or more of the following criteria will not be included in the trial. These exclusion criteria are valid for each year.
1. Received specific immunotherapy against birch pollen or a tree pollen mix including birch pollen at any time since AN004T and before Visit 1
2. Intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days
3. Unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device
4. Not covered by medical insurance
5. Received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period
6. Received systemic or local antihistamines, oral or inhaled corticosteroids or under anti depressant medication with antihistamine effect within 2 weeks prior to inclusion
7. Used any investigational or non-registered drug, vaccine, or medical device within 4 weeks prior to inclusion, or planned to use such treatments during the trial period |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy variable is the average of the combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) obtained daily during the birch pollen season. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Start day of each birch pollen season until end day of each birch pollen season |
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E.5.2 | Secondary end point(s) |
• Average quality-of-life total score
The average of the total score of the validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) obtained weekly during the birch pollen season.
• Average of the Night-time Nasal Symptom Score (NNSS) obtained daily during the birch pollen season.
• Average of the combined Rhinoconjunctivitis and Night-time Symptom and Medication Score (RNSMS) obtained daily during the birch pollen season
• Percentage of well days during the birch pollen season
The percentage of well days over the number of days of the birch pollen season when the daily questionnaires were completed.
• Percentage of days with severe symptoms during the birch pollen season
The percentage of days with severe symptoms over the number of days of the birch pollen season when the daily questionnaires were completed.
• Subject’s global evaluation of treatment efficacy collected at Visit V3 of each year
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Start day of each birch pollen season until end day of each birch pollen season |
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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 | Yes |
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) | 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 | 3 |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 22 |
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 |
Denmark |
France |
Sweden |
Latvia |
Lithuania |
Poland |
Switzerland |
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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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The end of this trial is defined as the date of the last visit of the last patient in the study. |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 |