Mite Asthma Pediatric Immunotherapy Trial

Phase 3 Completed 533 enrolled ALK-Abelló A/S

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic asthma based on clinically relevant asthma worsening.

Timeline

Start: 2018-02-22
Primary completion: 2022-05-18
Completion: 2022-05-31

Outcome

Missed primary endpoint

registry analysis (superiority test); HDM SLIT-tablet (12 SQ-HDM) vs Placebo SLIT-tablet; p = 0.5412; Rate ratio 0.89 (95% CI 0.60 to 1.31); Negative binomial regression NCT03654976 ↗

paper contributing to the primary endpoint not being met. PMID 41064908 ↗

Publications

Roberts G, Just J, Nolte H, Hels OH, Emeryk A, Vidal C. SQ House Dust Mite Sublingual Immunotherapy Tablet in Children With Allergic Asthma: A Randomised Phase III Trial. Allergy. 2025 Dec;80(12):3401-3411. doi: 10.1111/all.70073. Epub 2025 Oct 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HDM SLIT-tablet	Unknown	1 unknown	Other