A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis

Study Overview
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Brief Summary
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This is a clinical study in children and adolescents (5-17 years) with allergy to pollen from birch (or related trees). It compares the tree SLIT-tablet with placebo in relieving rhinoconjunctivitis symptoms during the birch/tree pollen season based on the average allergic rhinoconjunctivitis daily total combined score. The study will also collect health-related quality of life information in the groups treated with the tree SLIT-tablet or with placebo during the pollen season. The trial medication used is already approved to treat allergic rhinitis caused by birch/tree pollen in adults in several countries?.

Detailed Description
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This is a phase III, parallel-group, double-blind, placebo-controlled study to evaluate efficacy and safety of the tree SLIT-tablet in children and adolescents (5-17 years) who have rhinoconjunctivitis (with or without asthma) induced by pollen from birch trees or by trees belonging to the birch homologous group. Approximately 1000 children and adolescents will be enrolled in the trial and will receive either the tree SLIT-tablet or placebo. The trial consists of 3 periods: a screening period, a treatment period, which includes pre-seasonal and co seasonal treatment, and a follow-up period. The duration is up to 13 months for each participant. The trial is conducted in several European countries and in Canada.

Official Title
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Efficacy and Safety of the SQ Tree Sublingual Immunotherapy Tablet in Children and Adolescents With Moderate to Severe Allergic Rhinitis and/or Conjunctivitis Induced by Pollen From Birch and Trees Belonging to the Birch Homologous Group

Conditions
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Allergy

Intervention / Treatment
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* Drug: SQ tree SLIT-tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female of any race/ethnicity aged ≥4 to <18 years on the day informed consent is obtained from the parent/caregiver; the subject must be ≥5 to <18 years old at the randomisation visit A documented , physician diagnosed, clinically relevant history of moderate to severe AR/C induced by birch pollen (with or without asthma) despite having received treatment with symptom-relieving medication during at least 1 previous tree pollen season for ages 4 through 6 years at screening or at least 2 previous tree pollen seasons for ages 7 through 17 years at screening Positive skin prick test (SPT) to Betula verrucosa at screening Positive specific IgE to Bet v at screening Presence of 1 or more of the following Allergic Rhinitis Impact on Asthma (ARIA) quality of life items due to AR/C during the previous BPS: Sleep disturbance Impairment of daily activities, leisure and/or sport Impairment of school or work Troublesome symptoms Exclusion Criteria: A clinically relevant history of symptomatic seasonal AR/C caused by an allergen source, other than tree pollen from the birch homologous group, with a season overlapping the TPS A clinically relevant history of symptomatic perennial AR/C caused by an allergen source such as animal hair and dander to which the subject is exposed during the TPS Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation Reduced lung function at randomisation defined as forced expiratory volume in 1 second (FEV1) <70% of predicted value. For subjects with asthma, this is assessed on subject's usual asthma medication following at least a 6-hour wash-out of SABA. This criterion does not need to be fulfilled if the subject is <7 years old, cannot perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma Ongoing treatment with any allergy immunotherapy product Severe chronic oral inflammation A diagnosis of eosinophilic oesophagitis A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 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>Gelatine (fish source), mannitol and sodium hydroxide | Drug: Placebo<br>* Placebo<br>|
| Experimental: Intervention/treatment<br>Sublingual allergy immunotherapy tablet, for daily administration SQ tree SLIT-tablet | Drug: SQ tree SLIT-tablet<br>* Sublingual allergy immunotherapy tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average total combined score (rhinoconjunctivitis symptoms and medication use) during the birch pollen season | European Academy of Allergy and Clinical Immunology - values 0,1,2 (The higher score means more symptoms and more rescue medication used) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average total combined score (rhinoconjunctivitis symptoms and medication use) during the tree pollen season | European Academy of Allergy and Clinical Immunology - values 0,1,2 (The higher score means more symptoms and more rescue medication used) | 6 months | 
| Average daily symptom score during the birch pollen season | Sum of the 6 allergic rhinoconjunctivitis symptom scores; No symptoms (0), Mild symptoms (1), Moderate symptoms (2), Severe symptoms (3). Total scores will be between 0-18 (higher scores means more symptoms) | 3 months | 
| Average daily symptom score during the tree pollen season | Sum of the 6 allergic rhinoconjunctivitis symptom scores; No symptoms (0), Mild symptoms (1), Moderate symptoms (2), Severe symptoms (3). Total scores will be between 0-18 (higher scores means more symptoms) | 6 months | 
| Average daily medication score during the birch pollen season | The type and dose of rescue medication will be scored. Scores between 0-20 (the higher value means the most rescue medication used) | 3 months | 
| Average daily medication score during the tree pollen season | The type and dose of rescue medication will be scored. Scores between 0-20 (the higher value means the most rescue medication used) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinoconjunctivitis, Children, Adolescents, Birch