NCT07060885

A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65

A Randomised Double-blind Placebo-controlled Phase III Field Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Chinese Participants Aged 12-65 Years With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.

Detailed description

The trial aims to evaluate efficacy of the house dust mite (HDM) SLIT-tablet compared to placebo in Chinese participants aged 12-65 with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Efficacy will be assessed based on the total combined rhinitis score during the last 4 weeks of treatment. The trial is a randomised, double-blind, parallel-group, placebo-controlled, multi-site, phase III trial conducted in China. The treatment period will be 24-28 weeks.

Conditions

• Allergic Rhinoconjunctivitis
• Allergic Rhinitis

Interventions

Type	Name	Description
BIOLOGICAL	HDM SLIT-tablet (12 SQ-HDM)	For daily administration (1 tablet per day) Other Names: Acarizax, Odactra
OTHER	Placebo	For daily administration (1 tablet per day)

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2025-07-11
• Last updated: 2025-12-31

Locations

30 sites across 1 country: China