ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen

Study Overview
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Brief Summary
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A multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT, a Combination of Contiguous Overlapping Peptides Derived from Bet v 1, in Adults with Birch Pollen Allergic Rhinitis/Rhinoconjunctivitis

Official Title
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A Multicentre, Double-blind, Placebo-Controlled, Randomized Trial to Assess the Efficacy and Tolerability of Two Dosing Regimens of AllerT in Adults With Birch Pollen Allergic Rhinitis

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: AllerT
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult subjects 18 to 65 yrs old, male or female moderate to severe allergic Rhinitis/Rhinoconjunctivitis to birch pollen during the two preceding birch pollen seasons positive Skin Prick Test (SPT) to birch pollen extract positive specific IgE CAP to Bet v1. Exclusion Criteria: persistent non-controlled asthma (Forced Expiratory Volume, FEV1 < 85% of predicted), previous specific immunotherapy (SIT) to tree pollens, previous SIT to any allergen within 5 years, previous history of severe anaphylactic reaction, perennial allergic Rhinitis/Rhinoconjunctivitis, other disorder possibly influencing the trial outcomes, pregnancy, any severely debilitating disease, primary or secondary immunodeficiency or treatment with immunosuppressor drugs within one month prior to randomization (oral steroids, other immunosuppressors).

Ages Eligible for Study
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Minimum Age: 18 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: placebo<br>5 SC injections in 2 months | Drug: placebo<br>* placebo<br>|
| Experimental: AllerT 50 ug<br>5 SC injections in 2 months | Drug: AllerT<br>* Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution<br>|
| Experimental: AllerT 10 ug<br>5 SC injections in 2 months | Drug: AllerT<br>* Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined Symptom and Medication Score (CSMS) | the CSMS will be assessed daily throughout the first birch pollen season following the end of the preseasonal 2-month treatment. The difference in average daily CSMS per treatment group will be compared taking into account all days of the birch pollen season at each study center. All patients will receive treatment during the preceding winter or spring and will thus have the primary outcome assessment performed between 2 and 6 months after the end of treatment. | 2 to 6 months after the end of treatment |