A Research Study in Chinese People With Allergy to House Dust Mites, Using an Environmental Exposure Chamber

Study Overview
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Brief Summary
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This trial evaluates the efficacy and safety of HDM SLIT-tablet in treatment of HDM AR. The efficacy is evaluated using an environmental exposure chamber (EEC). Subjects will be randomised to receive treatment with HDM SLIT-tablet and placebo 1:1.

Detailed Description
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This trial is a 24 weeks, randomised, parallel-group, double-blind, placebo-controlled phase III trial. Approximately 202 subjects will be randomised (1:1) to receive treatment with HDM SLIT-tablet or placebo. The trial will be conducted in China, with subjects recruited and treated in China. Two EEC assessments (baseline and end of treatment) will take place at a validated EEC facility in Austria. The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet (12 SQ-HDM) once daily compared to placebo in the treatment of HDM AR nasal symptom determined during the EEC session at week 24.

Official Title
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A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Adult Chinese Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis Using an Environmental Exposure Chamber

Conditions
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Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Biological: Sublingual allergy immunological tablet
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Male or female Chinese subjects aged ≥18 years A clinical history of HDM AR/C with or without asthma Positive SPT and IgE to Der p or Der f at screening A TNSS of at least 6 of 12 within the first 2 hours of the screening EEC session prior to randomisation Exclusion criteria Sensitised and regularly exposed perennial or seasonal allergens Asthma requiring treatment with high-dose ICS Reduced lung function Has a nasal condition that could confound the efficacy or safety assessment A relevant history of systemic allergic reaction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>HDM SLIT-tablet once daily for approximately 24 weeks | Biological: Sublingual allergy immunological tablet<br>* For daily administration (1 tablet per day)<br>* Other names: Acarizax;|
| Placebo Comparator: Placebo<br>Placebo tablet once daily for approximately 24 weeks | Other: Placebo<br>* For daily administration (1 tablet per day)<br>* Other names: Placebo sublingual tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Score (TNSS) | Primary endpoint, average TNSS during the EEC session at week 24, defined as the average of all TNSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 12 (severe symptoms). | Last 4 hours of the EEC session at week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Symptom Score (TSS) | Key secondary endpoint, average TSS during the EEC session at week 24, defined as the sum of the Total Ocular Symptom Score (TOSS) and TNSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 18 (severe symptoms). | Last 4 hours of the EEC session at week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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House Dust Mite, Allergic rhinitis, Allergic conjunctivitis, China, Environmental exposure chamber