Phase 3 N=1,458 Randomized Double-blind Treatment

House Dust Mite Allergy Trial In Children

Allergic Rhinitis Due to Dermatophagoides Farinae · Allergic Rhinitis Due to Dermatophagoides Pteronyssinus · Allergic Rhinitis Due to House Dust Mite

Bottom Line

View on ClinicalTrials.gov: NCT04145219 ↗

Enrolled (actual)

1,458

Serious AEs

1.5%

Results posted

Jun 2024

Primary outcome: Primary: Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period — 3.4; 4.4 score on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Sublingual allergy immunotherapy tablet (Biological); Placebo (Other)
Age: Pediatric · 5+ yrs
Sex: All
Sponsor: ALK-Abelló A/S
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Daily Total Combined Rhinitis Symptom and Medication Score (TCRS) During the Primary Efficacy Assessment Period	3.4; 4.4	<0.0001 sig
SECONDARY The Average Rhinitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	1.5; 1.9	<0.0001 sig
SECONDARY The Average Rhinitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period	1.4; 1.9	0.0016 sig
SECONDARY The Average Daily Total Combined Rhinoconjunctivitis Symptom and Medication Score (TCS) During the Primary Efficacy Assessment Period	4.0; 5.2	<0.0001 sig
SECONDARY The Average Rhinoconjunctivitis Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	1.7; 2.2	<0.0001 sig
SECONDARY The Average Rhinoconjunctivitis Daily Medication Score (DMS) During the Primary Efficacy Assessment Period	1.8; 2.4	0.0018 sig
SECONDARY Overall Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score at the End of Trial	0.8; 1.0	<0.0001 sig
SECONDARY The Average Asthma Daily Symptom Score (DSS) During the Primary Efficacy Assessment Period	0.3; 0.4	0.0259 sig
SECONDARY SABA Free Days During the Primary Efficacy Assessment Period	99.2; 98.6	0.0527
SECONDARY Weekly Number of Puffs of As-needed SABA Use During the Primary Efficacy Assessment Period	1.0; 1.5	0.1256
SECONDARY Rhinitis Mild Days During the Primary Efficacy Assessment Period	31.8; 20.9	0.0008 sig
SECONDARY Rhinitis Exacerbation Days During the Primary Efficacy Assessment Period	2.5; 4.4	<0.0001 sig
SECONDARY Average Rhinitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period	0.8; 1.0	<0.0001 sig
SECONDARY Average Rhinoconjunctivitis Combined Symptom and Medication Score (CSMS) During the Primary Efficacy Assessment Period	0.7; 0.9	<0.0001 sig
SECONDARY House Dust Mite Specific IgE	0.2; 0.0; 0.3; 0.0	—
SECONDARY House Dust Mite Specific IgG4	0.6; 0.0; 0.7; 0.0	—
SECONDARY Total IgE	0.2; 0.0	—
SECONDARY House Dust Mite IgE-Blocking Factor	0.4; -0.0	—

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)

Eligibility Criteria

Inclusion Criteria

Male or female subjects aged 5-11 years
A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period
Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D. farinae at screening
Lung function ≥ 70% of predicted value

Exclusion Criteria

Sensitised and regularly exposed to perennial allergens
Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
Asthma requiring treatment with high dose of inhaled corticosteroid
A relevant history of systemic allergic reaction

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04145219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.