CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 253 enrolled
Drug / intervention
HDM SLIT-tabletbiological
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/NCT04541004
NCT04541004Phase 3Completed
CompareCT.gov

A 28-day, Single-armed, Open-label Trial to Evaluate Safety of the House Dust Mite (HDM) Sublingual Allergy Immunotherapy (SLIT) Tablet in Adolescent Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

ALK-Abelló A/S·interventional·Posted Sep 9, 2020·Updated Jul 3, 2023

In Brief

A Phase 3 clinical trial evaluating HDM SLIT-tablet for Allergic Rhinitis and Allergic Rhinoconjunctivitis. Completed, enrolled 253 participants across 27 sites in 3 countries.

Detailed Summary

This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis. The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies. The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAllergic Rhinitis, Allergic Rhinoconjunctivitis
CountriesCzechia, Germany, Slovakia
CollaboratorsSyneos Health

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedSep 9, 2020
Enrollment StartSep 23, 2020
Primary CompletionApr 24, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.8 years ago

Interventions

HDM SLIT-tabletbiological

Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)