Efficacy and safety of the SQ tree sublingual immunotherapy tablet in children and adolescents (5 through 17 years of age) with moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch and trees belonging to the birch homologous group

Phase 3

Completed

• Conditions: allergic rhinitis; tree allergy; 10001708

• Registration Number: NL-OMON51039
• Lead Sponsor: ALK-Abelló A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 68

Inclusion Criteria

Subjects are eligible to be included in the trial only if all the following
criteria apply:
• 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:
a. Sleep disturbance
b. Impairment of daily activities, leisure and/or sport
c. Impairment of school or work
d. Troublesome symptoms

Exclusion Criteria

Subjects are excluded from the trial if any of the following criteria apply:
• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the efficacy of the SQ tree SLIT-tablet to placebo in the treatment<br /><br>of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen<br /><br>from birch and trees belonging to the birch homologous group in children and<br /><br>adolescents (5 through 17 years of age) based on the average allergic<br /><br>rhinoconjunctivitis daily total combined score# (average TCS) during the birch<br /><br>pollen season (BPS)</p><br>