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

• Status: Recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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?.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ALK-Abelló A/S
• Collaborator: Parexel

Criteria

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:

1. Sleep disturbance

2. Impairment of daily activities, leisure and/or sport

3. Impairment of school or work

4. 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