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

NCT07060885 | Recruiting Phase 3

• 2 other identifiers: MT-212025-000321-14
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 30

Brief Summary

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

Conditions

Allergic Rhinoconjunctivitis; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period.

  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.

  4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.

Secondary Outcomes (5)

• Average daily values for rhinitis daily symptom score (DSS) during primary efficacy period.

  4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.

• Average daily values for rhinitis daily medication score (DMS) during primary efficacy period.

  4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.

• Average daily total combined score (TCS) during primary efficacy period.

  4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.

• Average rhinoconjunctivitis DSS during the primary efficacy assessment period

  4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.

• Average rhinoconjunctivitis DMS during the primary efficacy assessment period

  4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.

Study Arms (2)

Active treatment

EXPERIMENTAL

HDM SLIT-tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.

Biological: HDM SLIT-tablet (12 SQ-HDM)

Placebo

PLACEBO COMPARATOR

Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.

Other: Placebo

Interventions

HDM SLIT-tablet (12 SQ-HDM) BIOLOGICAL

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

Active treatment

Placebo OTHER

For daily administration (1 tablet per day)

Placebo

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (30)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

RECRUITING

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

The first hospital affiliated Fujian medical University

Fuzhou, Fujian, 350005, China

RECRUITING

The first affiliated hospital of guangzhou medical university-respiratory department

Guangzhou, Guangdong, 510120, China

RECRUITING

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

The Third Affilliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510630, China

RECRUITING

Shenzhen Children's Hospital - Respiratory

Shenzhen, Guangdong, 518026, China

RECRUITING

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

Shenzhen, Guangdong, 518052, China

RECRUITING

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

Zhuhai, Guangdong, 510275, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

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

Nanning, Guangxi, 530021, China

RECRUITING

Hainan General Hospital - Respiratory

Haikou, Hainan, 570311, China

RECRUITING

The Third Hospital of Changsha - Pulmonology

Changshacun, Henan, 410015, China

RECRUITING

The First Affiliated Hospital of University of South China - Endocrinology

Hengyang, Henan, 421001, China

RECRUITING

Jingzhou Central Hospital - Otorhinolaryngology

Jingzhou, Hubei, 434020, China

RECRUITING

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

Wuhan, Hubei, 430022, China

RECRUITING

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

Wuhan, Hubei, 430030, China

RECRUITING

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

Nanjing, Jiangsu, 210029, China

RECRUITING

The First Affiliated Hospital of Soochow University - Respiratory

Suzhou, Jiangsu, 215006, China

RECRUITING

Nanchang University - The First Affiliated Hospital

Nanchang, Jiangxi, 330046, China

RECRUITING

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330047, China

RECRUITING

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

Xi'an, Shaanxi, 710004, China

RECRUITING

Shanghai Jiaotong University School of Medicine, Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Sichuan, 100730, China

RECRUITING

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

Chengdu, Sichuan, 610017, China

RECRUITING

West China Hospital of Sichuan University - Otorhinolaryngology

Chengdu, Sichuan, 610041, China

RECRUITING

The First Affiliated Hospital of Chongqing Medical University - Respiratory

Chongqing, Sichuan, 400016, China

RECRUITING

Zhejiang provincial people's hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

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

Wenzhou, Zhejiang, 325027, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Head of Clinical Project Management

CONTACT

+45 45747576; clinicaltrials@alk.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 11, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (30)