A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65

NCT07060885 · tracked via the Priya Life Science China tracker

Sponsor

ALK-Abelló A/S

Phase

Phase 3

Started

2025-09-01

Last updated

2026-07-20

Condition(s) studied

Allergic RhinoconjunctivitisAllergic Rhinitis

Investigational drug(s) / intervention(s)

HDM SLIT-tablet (12 SQ-HDM)Placebo

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)

Study summary

A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.

Eligibility

Sex

ALL

Min age

12 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * Sensitised and regularly exposed to perennial allergens * 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

Primary outcome measure(s)

Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period. — 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.
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.

Trial sites (30)

Facility	City	Region
Beijing Tongren Hospital, Capital Medical University	Beijing	Beijing Municipality
Fujian Provincial Hospital	Fuzhou	Fujian
The first hospital affiliated Fujian medical University	Fuzhou	Fujian
The first affiliated hospital of guangzhou medical university-respiratory department	Guangzhou	Guangdong
The Third Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
The Third Affilliated Hospital of Southern Medical University	Guangzhou	Guangdong
Shenzhen Children's Hospital - Respiratory	Shenzhen	Guangdong
Huazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology	Shenzhen	Guangdong
The Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital	Zhuhai	Guangdong
The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region - Nephrology - Oncology	Nanning	Guangxi
Hainan General Hospital - Respiratory	Haikou	Hainan
The Third Hospital of Changsha - Pulmonology	Changshacun	Henan
The First Affiliated Hospital of University of South China - Endocrinology	Hengyang	Henan
Jingzhou Central Hospital - Otorhinolaryngology	Jingzhou	Hubei
Union Hospital Tongji Medical College Huazhong University of Science and Technology - Oncology	Wuhan	Hubei
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei
Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University - Otorhinolaryngology	Nanjing	Jiangsu
The First Affiliated Hospital of Soochow University - Respiratory	Suzhou	Jiangsu
Nanchang University - The First Affiliated Hospital	Nanchang	Jiangxi
The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
The Second Affiliated Hospital of Xi an Jiaotong University (Xibei Hospital) - Nephrology	Xi'an	Shaanxi
Shanghai Jiaotong University School of Medicine, Ruijin Hospital	Shanghai	Shanghai Municipality
Zhongshan Hospital	Shanghai	Shanghai Municipality
Peking Union Medical College Hospital	Beijing	Sichuan
Sichuan University - West China Second University Hospital (WCSUH) (West China Women's and Children's Hospital)	Chengdu	Sichuan
West China Hospital of Sichuan University - Otorhinolaryngology	Chengdu	Sichuan
The First Affiliated Hospital of Chongqing Medical University - Respiratory	Chongqing	Sichuan
Zhejiang provincial people's hospital	Hangzhou	Zhejiang
The 2nd School of Medicine, WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU - Pediatrics	Wenzhou	Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07060885 on ClinicalTrials.gov ↗ ← All trials in China