Status:
COMPLETED
A Study in Children and Adolescents With Birch Pollen-induced Rhinoconjunctivitis
Lead Sponsor:
ALK-Abelló A/S
Collaborating Sponsors:
Parexel
Conditions:
Allergy
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief 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 s...
Detailed Description
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 rhinoconjunctiviti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
952 Patients enrolled
Trial Details
Trial ID
NCT04878354
Start Date
April 7 2021
End Date
July 31 2023
Last Update
January 22 2025
Active Locations (80)
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1
Allergy Center Vienna West
Vienna, Austria, 1150
2
Medical University of Vienna
Vienna, Austria, A-1090
3
Practice Dr Jean-Benoit Martinot
Erpent, Namur, Belgium, 5101
4
Universitair Ziekenhuis Gent
Ghent, Oost-Vlandeeren, Belgium, 9000