Clinical Trials Directory

Trials / Completed

CompletedNCT04145219

House Dust Mite Allergy Trial In Children

A One-year Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Children (5-11 Years of Age) With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
1,460 (actual)
Sponsor
ALK-Abelló A/S · Industry
Sex
All
Age
5 Years – 11 Years
Healthy volunteers
Not accepted

Summary

A research study of how house dust mite tablets work compared to placebo in children aged between 5 and 11 years and who have allergy to house dust mites (MATIC)

Detailed description

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet compared to placebo in children (5-11 years of age) with House Dust Mite allergic rhinitis based on the total combined rhinitis symptoms and medication score during the last 8 weeks of treatment. In addition, the trial will evaluate safety and tolerability of the treatment, and assess whether treatment has an impact on asthma symptoms and medication use, immunological parameters, and rhinoconjunctivitis quality of life (QoL). The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national phase III trial conducted in Europe and North America. The treatment period will be approximately 1 year.

Conditions

Interventions

TypeNameDescription
BIOLOGICALSublingual allergy immunotherapy tabletFor daily administration (1 tablet per day)
OTHERPlaceboFor daily administration (1 tablet per day)

Timeline

Start date
2019-10-12
Primary completion
2023-04-01
Completion
2023-04-21
First posted
2019-10-30
Last updated
2024-06-12
Results posted
2024-06-12

Locations

113 sites across 11 countries: United States, Bulgaria, Canada, France, Germany, Lithuania, Poland, Russia, Slovakia, Spain, Ukraine

Regulatory

Source: ClinicalTrials.gov record NCT04145219. Inclusion in this directory is not an endorsement.