Efficacy Study of a Preseasonal Treatment With AllerT in Subjects With Birch Pollen Allergy

Study Overview
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Brief Summary
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The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch pollen season

Official Title
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Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen

Conditions
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Allergic Rhinitis, Rhinoconjunctivitis

Intervention / Treatment
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* Drug: placebo
* Drug: AllerT low dose
* Drug: AllerT full dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate to severe allergic rhinoconjunctivitis to birch pollen: Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons Previous use of anti-allergy medications during the two preceding birch pollen seasons Positive SPT to birch pollen extract Positive specific IgE CAP test for Bet v 1 Exclusion Criteria: uncontrolled asthma, FEV1 < 80% of predicted previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years clinical symptoms due to allergens other than birch pollen during the whole trial period history of anaphylaxis positive skin prick test to AllerT any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: placebo<br>SC injections of placebo | Drug: placebo<br>* SC injections of placebo on days 1, 7, 14, 28 and 56<br>|
| Experimental: AllerT low dose<br>SC injections of AllerT 25 or 50 micrograms | Drug: AllerT low dose<br>* SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56<br>* Other names: AllerT 25-50 micrograms;|
| Experimental: AllerT full dose<br>SC injections of AllerT 50-100 micrograms | Drug: AllerT full dose<br>* SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56<br>* Other names: AllerT 50-100 micrograms;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Rhinoconjunctivitis Symptom and Medication Score | The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first. The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2 | up to 6 weeks during the birch pollen season 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | mini-RQLQ questionnaires | up to 6 weeks during the birch pollen season 2013 | 
| Safety and Tolerability | Adverse events will be collected throughout the trial period and will be reported as Treatment emergent adverse events occurring between start of treatment and 28 days after completion of treatment for each subject | from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergic rhinitis, birch pollen, immunotherapy