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The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree AIT administered once daily in order to define a dose-range that would be suitable for at-home administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALK tree AIT Placebo | Placebo Comparator | 1 AIT administered sublingually every day |
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| ALK tree AIT 0.5 DU | Experimental | 1 AIT administered sublingually every day |
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| ALK tree AIT 1 DU | Experimental | 1 AIT administered sublingually every day |
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| ALK tree AIT 2 DU | Experimental | 1 AIT administered sublingually every day |
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| ALK tree AIT 4 DU | Experimental | 1 AIT administered sublingually every day |
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| ALK tree AIT 7 DU | Experimental | 1 AIT administered sublingually every day |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALK tree AIT 0.5 DU | Biological |
| ||
| ALK tree AIT 1 DU |
| Measure | Description | Time Frame |
|---|---|---|
| Allergy symptom severity scores on a scale from 0-3 | Determine the dose-efficacy response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the frequency and severity of adverse events, form the basis of the conclusion on the primary endpoint. | During the birch pollen season 2013, an expected average of 3 weeks |
| Adverse events frequency | Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint. | Throughout the trial, an expected average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events severity | Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint. | Throughout the trial, an expected average of 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin and Allergy Hospital, Helsinki University Central Hospital | Helsinki | HUS | 00029 | Finland | ||
| Slotervaart Ziekenhuis |
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| ALK tree AIT 12 DU | Experimental | 1 AIT administered sublingually every day |
|
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| ALK tree AIT 2 DU | Biological |
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| ALK tree AIT 4 DU | Biological |
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| ALK tree AIT 7 DU | Biological |
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| ALK tree AIT 12 DU | Biological |
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| ALK tree AIT Placebo | Biological |
|
| Amsterdam |
| 1066EC |
| Netherlands |