A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65
NCT ID: NCT07060885
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-09-01
2026-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active treatment
HDM SLIT-tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
HDM SLIT-tablet (12 SQ-HDM)
For daily administration (1 tablet per day)
Other Names: Acarizax, Odactra
Placebo
Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
Placebo
For daily administration (1 tablet per day)
Interventions
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HDM SLIT-tablet (12 SQ-HDM)
For daily administration (1 tablet per day)
Other Names: Acarizax, Odactra
Placebo
For daily administration (1 tablet per day)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
65 Years
ALL
No
Sponsors
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ALK-Abelló A/S
INDUSTRY
Responsible Party
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Locations
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Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
The first hospital affiliated Fujian medical University
Fuzhou, Fujian, China
The first affiliated hospital of guangzhou medical university-respiratory department
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Affilliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Children's Hospital - Respiratory
Shenzhen, Guangdong, China
Huazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology
Shenzhen, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital
Zhuhai, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The People's Hospital of Guangxi Zhuang Autonomous Region - Nephrology - Oncology
Nanning, Guangxi, China
Hainan General Hospital - Respiratory
Haikou, Hainan, China
The Third Hospital of Changsha - Pulmonology
Changshacun, Henan, China
The First Affiliated Hospital of University of South China - Endocrinology
Hengyang, Henan, China
Jingzhou Central Hospital - Otorhinolaryngology
Jingzhou, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology - Oncology
Wuhan, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University - Otorhinolaryngology
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University - Respiratory
Suzhou, Jiangsu, China
Nanchang University - The First Affiliated Hospital
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Xi an Jiaotong University (Xibei Hospital) - Nephrology
Xi'an, Shaanxi, China
Shanghai Jiaotong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Peking Union Medical College Hospital
Beijing, Sichuan, China
Sichuan University - West China Second University Hospital (WCSUH) (West China Women's and Children's Hospital)
Chengdu, Sichuan, China
West China Hospital of Sichuan University - Otorhinolaryngology
Chengdu, Sichuan, China
The First Affiliated Hospital of Chongqing Medical University - Respiratory
Chongqing, Sichuan, China
Zhejiang provincial people's hospital
Hangzhou, Zhejiang, China
The 2nd School of Medicine, WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU - Pediatrics
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Chengshuo Wang Principal Investigator
Role: primary
Yuyang Dai GCP Secretary
Role: backup
Ting Chen Principal Investigator
Role: primary
Jing Deng
Role: backup
Yuanteng Xu Principal Investigator
Role: primary
Anpeng Wu
Role: backup
Jing Li Principal Investigator
Role: primary
Gesi Wen
Role: backup
Qintai Yang Principal Investigator
Role: primary
Denglai Liu
Role: backup
Guangyong Tian Principal Investigator
Role: primary
Xiangfei Song
Role: backup
Yuejie Zheng Principal Investigator
Role: primary
Jiapeng He 何家朋 GCP office secretary
Role: backup
Liang Chen Principal Investigator
Role: primary
Jingfeng Qin GCP Secretary
Role: backup
Haiyu Hong Principal Investigator
Role: primary
Ming Ye 叶明 GCP office secretary
Role: backup
Guangyao He Principal Investigator
Role: primary
Ni Liu
Role: backup
Shenhong Qu Principal Investigator
Role: primary
Bi Deng
Role: backup
Xin Wei Principal Investigator
Role: primary
Haiyu Xue GCP Secretary
Role: backup
Ming Yang Principal Investigator
Role: primary
Zhiya Hu 胡智雅 GCP office secretary
Role: backup
Qingshan Jiang Principal Investigator
Role: primary
Pengju Ye，Juan Wen
Role: backup
Lijia Wan Principal Investigator
Role: primary
Zhen Xu
Role: backup
Jianjun Chen Principal Investigator
Role: primary
Li Zhang
Role: backup
RongFei Zhu Principal Investigator
Role: primary
Han Bai
Role: backup
Lei Cheng Principal Investigator
Role: primary
Peipei Shi
Role: backup
YaFeng Yu Principal Investigator
Role: primary
Ju Qian
Role: backup
Jing Ye Principal Investigator
Role: primary
Duanwen Cao
Role: backup
Hongbing Liu Principal Investigator
Role: primary
Zhao Yuan袁钊 GCP office secretary
Role: backup
Kang Zhu Principal Investigator
Role: primary
Yang Zhao
Role: backup
Wei Tang Principal Investigator
Role: primary
Jiajie Wu
Role: backup
Mei ling Principal Investigator
Role: primary
Role: backup
Kai Guan Principal Investigator
Role: primary
Chi Zhang
Role: backup
Ping Wei Principal Investigator
Role: primary
Weiyi Guo
Role: backup
Juan Meng Principal Investigator
Role: primary
Hao Xiao
Role: backup
Yucheng Yang Principal Investigator
Role: primary
Danyang Huang
Role: backup
Weiming Hu Principal Investigator
Role: primary
Di Zhao
Role: backup
Weixi Zhang Principal Investigator
Role: primary
Ceyi Zhang
Role: backup
Other Identifiers
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2025-000321-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MT-21
Identifier Type: -
Identifier Source: org_study_id