A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet

Study Overview
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Brief Summary
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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.

Official Title
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A Dose-response Evaluation of ALK Tree AIT

Conditions
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Birch Pollen Allergy

Intervention / Treatment
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* Biological: ALK tree AIT 0.5 DU
* Biological: ALK tree AIT 1 DU
* Biological: ALK tree AIT 2 DU
* Biological: ALK tree AIT 4 DU
* Biological: ALK tree AIT 7 DU
* Biological: ALK tree AIT 12 DU
* Biological: ALK tree AIT Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A history of moderate to severe birch pollen allergy Use of symptomatic medication for treatment of birch pollen allergy Positive skin prick test to birch extract Positive specific IgE against Bet v 1 Exclusion Criteria: Overlapping perennial allergies History of uncontrolled asthma within the last 3 months FEV1 < 70% of predicted value in adults or FEV1 < 80% of predicted value in adolescents Previous or ongoing treatment with immunotherapy

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: ALK tree AIT Placebo<br>1 AIT administered sublingually every day | Biological: ALK tree AIT Placebo<br> <br> |
| Experimental: ALK tree AIT 0.5 DU<br>1 AIT administered sublingually every day | Biological: ALK tree AIT 0.5 DU<br> <br> |
| Experimental: ALK tree AIT 1 DU<br>1 AIT administered sublingually every day | Biological: ALK tree AIT 1 DU<br> <br> |
| Experimental: ALK tree AIT 2 DU<br>1 AIT administered sublingually every day | Biological: ALK tree AIT 2 DU<br> <br> |
| Experimental: ALK tree AIT 4 DU<br>1 AIT administered sublingually every day | Biological: ALK tree AIT 4 DU<br> <br> |
| Experimental: ALK tree AIT 7 DU<br>1 AIT administered sublingually every day | Biological: ALK tree AIT 7 DU<br> <br> |
| Experimental: ALK tree AIT 12 DU<br>1 AIT administered sublingually every day | Biological: ALK tree AIT 12 DU<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |