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
Status: Recruiting
Location: See all (30) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 65
Healthy Volunteers: f
View:
• Male or female Chinese subjects aged 12-65 years
• 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
Locations
Other Locations
China
Beijing Tongren Hospital, Capital Medical University
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
The Third Hospital of Changsha - Pulmonology
RECRUITING
Changshacun
Sichuan University - West China Second University Hospital (WCSUH) (West China Women's and Children's Hospital)
RECRUITING
Chengdu
West China Hospital of Sichuan University - Otorhinolaryngology
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University - Respiratory
RECRUITING
Chongqing
Fujian Provincial Hospital
RECRUITING
Fuzhou
The first hospital affiliated Fujian medical University
RECRUITING
Fuzhou
The first affiliated hospital of guangzhou medical university-respiratory department
RECRUITING
Guangzhou
The Third Affiliated Hospital, Sun Yat-sen University
RECRUITING
Guangzhou
The Third Affilliated Hospital of Southern Medical University
RECRUITING
Guangzhou
Hainan General Hospital - Respiratory
RECRUITING
Haikou
Zhejiang provincial people's hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of University of South China - Endocrinology
RECRUITING
Hengyang
Jingzhou Central Hospital - Otorhinolaryngology
RECRUITING
Jingzhou
Nanchang University - The First Affiliated Hospital
RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University - Otorhinolaryngology
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
The People's Hospital of Guangxi Zhuang Autonomous Region - Nephrology - Oncology
RECRUITING
Nanning
Shanghai Jiaotong University School of Medicine, Ruijin Hospital
RECRUITING
Shanghai
Zhongshan Hospital
RECRUITING
Shanghai
Huazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology
RECRUITING
Shenzhen
Shenzhen Children's Hospital - Respiratory
RECRUITING
Shenzhen
The First Affiliated Hospital of Soochow University - Respiratory
RECRUITING
Suzhou
The 2nd School of Medicine, WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU - Pediatrics
RECRUITING
Wenzhou
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
RECRUITING
Wuhan
Union Hospital Tongji Medical College Huazhong University of Science and Technology - Oncology
RECRUITING
Wuhan
The Second Affiliated Hospital of Xi an Jiaotong University (Xibei Hospital) - Nephrology
RECRUITING
Xi'an
The Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital
RECRUITING
Zhuhai
Contact Information
Primary
Head of Clinical Project Management
clinicaltrials@alk.net
+45 45747576
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2026-08
Participants
Target number of participants: 300
Treatments
Experimental: Active treatment
HDM SLIT-tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
Placebo_comparator: Placebo
Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
Related Therapeutic Areas
Sponsors
Leads: ALK-Abelló A/S