CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 952 enrolled
Drug / intervention
Tree SLIT-tablet +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04878354
NCT04878354Phase 3Completed

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

ALK-Abelló A/S·interventional·Posted May 7, 2021·Updated Jan 22, 2025

In Brief

A Phase 3 clinical trial evaluating Tree SLIT-tablet and Placebo SLIT-tablet for Allergy. Completed, enrolled 952 participants across 80 sites in 11 countries.

Detailed 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?.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergy
CountriesAustria, Belgium, Canada, Denmark, Germany, Hungary, Lithuania, Netherlands, Poland, Russia, Slovakia
CollaboratorsParexel

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMay 7, 2021
Enrollment StartApr 7, 2021
Primary CompletionJul 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.2 years ago

Interventions

Tree SLIT-tabletdrug

Sublingual allergy immunotherapy tablets

Placebo SLIT-tabletdrug

Placebo