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

Not Applicable

Not yet recruiting

• Conditions: Allergic Rhinoconjunctivitis; Allergic Rhinitis
• Interventions: Biological: HDM SLIT-tablet (12 SQ-HDM); Other: Placebo

• Registration Number: NCT07060885
• Lead Sponsor: ALK-Abelló A/S

Brief 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Study Start: 2025-09-01
• Primary Completion: 2026-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Male or female Chinese subjects aged 12-65 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active treatment	HDM SLIT-tablet (12 SQ-HDM)	HDM SLIT-tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
Placebo	Placebo	Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.

Primary Outcome Measures

Name	Time	Method
Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period.	4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.	The average daily TCRS evaluates the treatment effect as the difference in daily rhinitis symptoms and medication score (on a scale from 0-24) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.

Secondary Outcome Measures

Name	Time	Method
Average daily values for rhinitis daily symptom score (DSS) during primary efficacy period.	4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.	The average rhinitis DSS evaluates the treatment effect as the difference in daily rhinitis symptoms score (on a scale from 0-12) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.
Average daily values for rhinitis daily medication score (DMS) during primary efficacy period.	4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.	Average rhinitis DMS evaluates the treatment effect as the difference in daily rhinitis medication use (on a scale of 0-12) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.
Average daily total combined score (TCS) during primary efficacy period.	4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.	Average rhinoconjunctivitis TCS evaluates the treatment effect as the difference in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.
Average rhinoconjunctivitis DSS during the primary efficacy assessment period	4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.	The average rhinoconjunctivitis DSS evaluates the treatment effect as the difference in daily rhinoconjunctivitis symptom score (on a scale of 0-18) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.
Average rhinoconjunctivitis DMS during the primary efficacy assessment period	4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.	The average rhinoconjunctivitis DMS evaluates the treatment effect as the difference in daily rhinoconjunctivitis medication use (on a scale of 0-20) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.

Trial Locations

Locations (1)

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, China