House Dust Mite Allergy Trial In Children

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)

Timeline

Start

2019-10-12

Primary completion

2023-04-01

Completion

2023-04-21

Outcome

Met primary endpoint

registry analysis (superiority test); HDM SLIT-tablet (12 SQ-HDM) vs Placebo SLIT-tablet; p <0.0001; Mean Difference (Final Values) 1.0 (95% CI 0.5 to 1.4) NCT04145219 ↗

release “Primary and all key secondary confirmatory endpoints w ere met, with a n improvement in the total combined allergic rhinitis score (TCRS) of 22 %” alk.net ↗

Publications

• Schuster A, Caimmi D, Nolte H, Novakova S, Mikler J, Foss-Skiftesvik MH, Osterdal AS, Emeryk A, Gagnon R, Pfaar O. Efficacy and safety of SQ house dust mite sublingual immunotherapy-tablet (12 SQ-HDM) in children with allergic rhinitis/rhinoconjunctivitis with or without asthma (MT-12): a randomised, double-blind, placebo-controlled, phase III trial. Lancet Reg Health Eur. 2024 Nov 26;48:101136. doi: 10.1016/j.lanepe.2024.101136. eCollection 2025 Jan.
• Field K, Blaiss MS. Sublingual Versus Subcutaneous Immunotherapy for Allergic Rhinitis: What Are the Important Therapeutic and Real-World Considerations? Curr Allergy Asthma Rep. 2020 Jun 16;20(9):45. doi: 10.1007/s11882-020-00934-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sublingual allergy immunotherapy tablet	Unknown	12 unknown	Other

Indications