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NCT07060885 | RECRUITING | Allergic Rhinoconjunctivitis


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

ALK-Abelló A/S

Brief Summary:

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

Condition or disease

Allergic Rhinoconjunctivitis

Allergic Rhinitis

Intervention/treatment

HDM SLIT-tablet (12 SQ-HDM)

Placebo

Phase

PHASE3

Detailed Description:

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:
Criteria
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

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

Location Details

NCT07060885


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Locations


RECRUITING

China, Beijing Municipality

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100730

RECRUITING

China, Fujian

Fujian Provincial Hospital

F U axis, Fujian, China, 350001

RECRUITING

China, Fujian

The first hospital affiliated Fujian medical University

F U axis, Fujian, China, 350005

RECRUITING

China, Guangdong

The first affiliated hospital of guangzhou medical university-respiratory department

Guangzhou, Guangdong, China, 510120

RECRUITING

China, Guangdong

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510630

RECRUITING

China, Guangdong

The Third Affilliated Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510630

RECRUITING

China, Guangdong

Shenzhen Children's Hospital - Respiratory

Shenzhen, Guangdong, China, 518026

RECRUITING

China, Guangdong

Huazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology

Shenzhen, Guangdong, China, 518052

RECRUITING

China, Guangdong

The Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital

Z tiger returns, Guangdong, China, 510275

RECRUITING

China, Guangxi

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China, 530021

RECRUITING

China, Guangxi

The People's Hospital of Guangxi Zhuang Autonomous Region - Nephrology - Oncology

Nanning, Guangxi, China, 530021

RECRUITING

China, Hainan

Hainan General Hospital - Respiratory

Haikou, Hainan, China, 570311

RECRUITING

China, Henan

The Third Hospital of Changsha - Pulmonology

Changsha Village, Henan, China, 410015

RECRUITING

China, Henan

The First Affiliated Hospital of University of South China - Endocrinology

H-like, Henan, China, 421001

RECRUITING

China, Hubei

Jingzhou Central Hospital - Otorhinolaryngology

Jingzhou, Hubei, China, 434020

RECRUITING

China, Hubei

Union Hospital Tongji Medical College Huazhong University of Science and Technology - Oncology

Wuhan, Hubei, China, 430022

RECRUITING

China, Hubei

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China, 430030

RECRUITING

China, Jiangsu

Jiangsu Province Hospital/ The First Affiliated Hospital with Nanjing Medical University - Otorhinolaryngology

Nanjing, Jiangsu, China, 210029

RECRUITING

China, Jiangsu

The First Affiliated Hospital of Soochow University - Respiratory

Suzhou, Jiangsu, China, 215006

RECRUITING

China, Jiangxi

Nanchang University - The First Affiliated Hospital

Nanchang, Jiangxi, China, 330046

RECRUITING

China, Jiangxi

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330047

RECRUITING

China, Shaanxi

The Second Affiliated Hospital of Xi an Jiaotong University (Xibei Hospital) - Nephrology

Xi'an, Shaanxi, China, 710004

RECRUITING

China, Shanghai Municipality

Shanghai Jiaotong University School of Medicine, Ruijin Hospital

Shanghai, Shanghai Municipality, China, 200025

RECRUITING

China, Shanghai Municipality

Zhongshan Hospital

Shanghai, Shanghai Municipality, China, 200032

RECRUITING

China, Sichuan

Peking Union Medical College Hospital

Beijing, Sichuan, China, 100730

RECRUITING

China, Sichuan

Sichuan University - West China Second University Hospital (WCSUH) (West China Women's and Children's Hospital)

Chengdu, Sichuan, China, 610017

RECRUITING

China, Sichuan

West China Hospital of Sichuan University - Otorhinolaryngology

Chengdu, Sichuan, China, 610041

RECRUITING

China, Sichuan

The First Affiliated Hospital of Chongqing Medical University - Respiratory

Chongqing, Sichuan, China, 400016

RECRUITING

China, Zhejiang

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, China, 310014

RECRUITING

China, Zhejiang

The 2nd School of Medicine, WMU/The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU - Pediatrics

Wenzhou, Zhejiang, China, 325027

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