RecruitingPhase 3NCT07060885

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

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

Sponsor

ALK-Abelló A/S

Enrollment

300 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Allergic Rhinitis Allergic Rhinoconjunctivitis

Summary

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

Eligibility

Min Age: 12 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a house dust mite (HDM) allergy tablet placed under the tongue (sublingual immunotherapy) in Chinese participants aged 12-65 to see whether it reduces allergy symptoms like runny nose and watery eyes over time. The idea behind this treatment is to desensitize the immune system to dust mite allergens. **You may be eligible if...** - You are between 12 and 65 years of age - You are of Chinese ethnicity - You have a clinical history of allergic rhinitis (hay fever-type symptoms) caused by house dust mites, with or without asthma - Your allergy symptoms persisted despite taking standard allergy medications in the prior year - You have a confirmed positive skin prick or blood test for house dust mite allergy **You may NOT be eligible if...** - You have severe or unstable asthma - You have a history of severe allergic reactions (anaphylaxis) - You have other serious health conditions (autoimmune disease, cancer, significant heart or lung disease) - You are pregnant or planning to become pregnant - You are already receiving allergen immunotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHDM SLIT-tablet (12 SQ-HDM)

For daily administration (1 tablet per day) Other Names: Acarizax, Odactra

OTHERPlacebo

For daily administration (1 tablet per day)

Locations(30)

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

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NCT07060885

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