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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-000321-14 | EudraCT Number |
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| Name | Class |
|---|---|
| Changchun GeneScience Pharmaceutical Co., Ltd. | INDUSTRY |
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A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Experimental | HDM SLIT-tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms. |
|
| Placebo | Placebo Comparator | Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM SLIT-tablet (12 SQ-HDM) | Biological | For daily administration (1 tablet per day) Other Names: Acarizax, Odactra |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period. | 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. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
| Measure | Description | Time Frame |
|---|---|---|
| Average daily values for rhinitis daily symptom score (DSS) during primary efficacy period. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University | Beijing | Beijing Municipality | 100730 | China | ||
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| Placebo | Other | For daily administration (1 tablet per day) |
|
| 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
| Average daily values for rhinitis daily medication score (DMS) during primary efficacy period. | 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. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
| Average daily total combined score (TCS) during primary efficacy period. | 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 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
| Average rhinoconjunctivitis DSS during the primary efficacy assessment period | 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. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
| Average rhinoconjunctivitis DMS during the primary efficacy assessment period | 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. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. |
| Fujian Provincial Hospital |
| Fuzhou |
| Fujian |
| 350001 |
| China |
| The first hospital affiliated Fujian medical University | Fuzhou | Fujian | 350005 | China |
| The first affiliated hospital of guangzhou medical university-respiratory department | Guangzhou | Guangdong | 510120 | China |
| The Third Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
| The Third Affilliated Hospital of Southern Medical University | Guangzhou | Guangdong | 510630 | China |
| Shenzhen Children's Hospital - Respiratory | Shenzhen | Guangdong | 518026 | China |
| Huazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology | Shenzhen | Guangdong | 518052 | China |
| The Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital | Zhuhai | Guangdong | 510275 | China |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China |
| The People's Hospital of Guangxi Zhuang Autonomous Region - Nephrology - Oncology | Nanning | Guangxi | 530021 | China |
| Hainan General Hospital - Respiratory | Haikou | Hainan | 570311 | China |
| The Third Hospital of Changsha - Pulmonology | Changshacun | Henan | 410015 | China |
| The First Affiliated Hospital of University of South China - Endocrinology | Hengyang | Henan | 421001 | China |
| Jingzhou Central Hospital - Otorhinolaryngology | Jingzhou | Hubei | 434020 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology - Oncology | Wuhan | Hubei | 430022 | China |
| Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology | Wuhan | Hubei | 430030 | China |
| Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University - Otorhinolaryngology | Nanjing | Jiangsu | 210029 | China |
| The First Affiliated Hospital of Soochow University - Respiratory | Suzhou | Jiangsu | 215006 | China |
| Nanchang University - The First Affiliated Hospital | Nanchang | Jiangxi | 330046 | China |
| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330047 | China |
| The Second Affiliated Hospital of Xi an Jiaotong University (Xibei Hospital) - Nephrology | Xi'an | Shaanxi | 710004 | China |
| Shanghai Jiaotong University School of Medicine, Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
| Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| Peking Union Medical College Hospital | Beijing | Sichuan | 100730 | China |
| Sichuan University - West China Second University Hospital (WCSUH) (West China Women's and Children's Hospital) | Chengdu | Sichuan | 610017 | China |
| West China Hospital of Sichuan University - Otorhinolaryngology | Chengdu | Sichuan | 610041 | China |
| The First Affiliated Hospital of Chongqing Medical University - Respiratory | Chongqing | Sichuan | 400016 | China |
| Zhejiang provincial people's hospital | Hangzhou | Zhejiang | 310014 | China |
| The 2nd School of Medicine, WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU - Pediatrics | Wenzhou | Zhejiang | 325027 | China |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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