ALK-Abelló A/S
A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
Allergic Rhinoconjunctivitis
Allergic Rhinitis
HDM SLIT-tablet (12 SQ-HDM)
Placebo
PHASE3
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 Type : | INTERVENTIONAL |
| Estimated Enrollment : | 300 participants |
| Masking : | QUADRUPLE |
| Primary Purpose : | TREATMENT |
| Official 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 |
| Actual Study Start Date : | 2025-09-01 |
| Estimated Primary Completion Date : | 2026-07 |
| Estimated Study Completion Date : | 2026-08 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 12 Years to 65 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100730
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Fujian Provincial Hospital
F U axis, Fujian, China, 350001
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The first hospital affiliated Fujian medical University
F U axis, Fujian, China, 350005
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The first affiliated hospital of guangzhou medical university-respiratory department
Guangzhou, Guangdong, China, 510120
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The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
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The Third Affilliated Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510630
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Shenzhen Children's Hospital - Respiratory
Shenzhen, Guangdong, China, 518026
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Huazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology
Shenzhen, Guangdong, China, 518052
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The Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital
Z tiger returns, Guangdong, China, 510275
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The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
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The People's Hospital of Guangxi Zhuang Autonomous Region - Nephrology - Oncology
Nanning, Guangxi, China, 530021
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Hainan General Hospital - Respiratory
Haikou, Hainan, China, 570311
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The Third Hospital of Changsha - Pulmonology
Changsha Village, Henan, China, 410015
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The First Affiliated Hospital of University of South China - Endocrinology
H-like, Henan, China, 421001
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Jingzhou Central Hospital - Otorhinolaryngology
Jingzhou, Hubei, China, 434020
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Union Hospital Tongji Medical College Huazhong University of Science and Technology - Oncology
Wuhan, Hubei, China, 430022
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Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China, 430030
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Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University - Otorhinolaryngology
Nanjing, Jiangsu, China, 210029
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The First Affiliated Hospital of Soochow University - Respiratory
Suzhou, Jiangsu, China, 215006
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Nanchang University - The First Affiliated Hospital
Nanchang, Jiangxi, China, 330046
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The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330047
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The Second Affiliated Hospital of Xi an Jiaotong University (Xibei Hospital) - Nephrology
Xi'an, Shaanxi, China, 710004
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Shanghai Jiaotong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200025
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Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032
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Peking Union Medical College Hospital
Beijing, Sichuan, China, 100730
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Sichuan University - West China Second University Hospital (WCSUH) (West China Women's and Children's Hospital)
Chengdu, Sichuan, China, 610017
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West China Hospital of Sichuan University - Otorhinolaryngology
Chengdu, Sichuan, China, 610041
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The First Affiliated Hospital of Chongqing Medical University - Respiratory
Chongqing, Sichuan, China, 400016
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Zhejiang provincial people's hospital
Hangzhou, Zhejiang, China, 310014
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The 2nd School of Medicine, WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU - Pediatrics
Wenzhou, Zhejiang, China, 325027