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COVID-19
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | HDM SLIT-tablet once daily for approximately 24 weeks |
|
| Placebo | Placebo Comparator | Placebo tablet once daily for approximately 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual allergy immunological tablet | Biological | For daily administration (1 tablet per day) |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | Number of Adverse events per treatment group | 26 weeks |
| Assessment of lung function | FEV1 | 26 weeks |
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Luo Zhang, Prof. | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Challenge Chamber | Vienna | 1150 | Austria | |||
| Tongren Hospital |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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Parallel assignment
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Randomised
| Placebo | Other | For daily administration (1 tablet per day) |
|
|
| Total Ocular Symptom Score (TOSS) | Average TOSS during the EEC session at week 24, defined as the average of all TOSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 6 (severe symptoms). | Last 4 hours of the EEC session at week 24 |
| Immunology | Change from baseline in measurements of house-dust-mite-specific IgG & IgE antibodies | Baseline to 24 weeks |
| Beijing |
| China |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |