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NCT Number: NCT07060885

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Allergic Rhinoconjunctivitis Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HDM SLIT-tablet (12 SQ-HDM)

Biological

For daily administration (1 tablet per day)

Other Names: Acarizax, Odactra

Placebo

Other

For daily administration (1 tablet per day)

Primary outcomes

  1. Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period.

    Time frame: 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 outcomes

  1. Average daily values for rhinitis daily symptom score (DSS) during primary efficacy period.

    Time frame: 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.

  2. Average daily values for rhinitis daily medication score (DMS) during primary efficacy period.

    Time frame: 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.

  3. Average daily total combined score (TCS) during primary efficacy period.

    Time frame: 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.

  4. Average rhinoconjunctivitis DSS during the primary efficacy assessment period

    Time frame: 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.

  5. Average rhinoconjunctivitis DMS during the primary efficacy assessment period

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Collaborators

  • Changchun GeneScience Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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