NCT04878354

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 952 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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?.

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 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.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	Tree SLIT-tablet	Sublingual allergy immunotherapy tablets
DRUG	Placebo SLIT-tablet	Placebo

Timeline

• Start date: 2021-04-07
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2021-05-07
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

80 sites across 11 countries: Austria, Belgium, Canada, Denmark, Germany, Hungary, Lithuania, Netherlands, Poland, Russia, Slovakia