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Allergic RhinoconjunctivitisPhase 3NCT07060885

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

A Phase 3 study testing HDM SLIT-tablet (12 SQ-HDM) in people with Allergic Rhinoconjunctivitis and Allergic Rhinitis, run by ALK-Abelló A/S at 30 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 12 to 65 years
What is being tested?
HDM SLIT-tablet (12 SQ-HDM)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
327 participants
Where
30 sitesChina
Study dates
1 Sep 2025to 10 Sep 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites

  • Beijing Tongren Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100730

  • Peking Union Medical College Hospital

    Beijing, Sichuan, 100730

  • The Third Hospital of Changsha - Pulmonology

    Changshacun, Henan, 410015

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

    Chengdu, Sichuan, 610017

  • West China Hospital of Sichuan University - Otorhinolaryngology

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital of Chongqing Medical University - Respiratory

    Chongqing, Sichuan, 400016

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

  • The first hospital affiliated Fujian medical University

    Fuzhou, Fujian, 350005

  • The first affiliated hospital of guangzhou medical university-respiratory department

    Guangzhou, Guangdong, 510120

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510630

  • The Third Affilliated Hospital of Southern Medical University

    Guangzhou, Guangdong, 510630

  • Hainan General Hospital - Respiratory

    Haikou, Hainan, 570311

  • Zhejiang provincial people's hospital

    Hangzhou, Zhejiang, 310014

  • The First Affiliated Hospital of University of South China - Endocrinology

    Hengyang, Henan, 421001

  • Jingzhou Central Hospital - Otorhinolaryngology

    Jingzhou, Hubei, 434020

  • Nanchang University - The First Affiliated Hospital

    Nanchang, Jiangxi, 330046

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330047

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

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

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

    Nanning, Guangxi, 530021

  • Shanghai Jiaotong University School of Medicine, Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

  • Zhongshan Hospital

    Shanghai, Shanghai Municipality, 200032

  • Shenzhen Children's Hospital - Respiratory

    Shenzhen, Guangdong, 518026

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

    Shenzhen, Guangdong, 518052

  • The First Affiliated Hospital of Soochow University - Respiratory

    Suzhou, Jiangsu, 215006

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

    Wenzhou, Zhejiang, 325027

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430030

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

    Xi'an, Shaanxi, 710004

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

    Zhuhai, Guangdong, 510275

Other trials in China

About this study

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

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

Read the 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.

Being tested
HDM SLIT-tablet (12 SQ-HDM), Placebo
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    For daily administration (1 tablet per day)

    Other Names: Acarizax, Odactra

  • PlaceboOther

    For daily administration (1 tablet per day)

Study groups in NCT07060885
Study groupRoleWhat they receive
Active treatmentExperimentalHDM SLIT-tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
Receives: Biological: HDM SLIT-tablet (12 SQ-HDM)
PlaceboPlacebo comparatorPlacebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks (primary efficacy assessment period), starting 20-24 weeks after initiation of IMP.

Secondary outcomes (5)

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

    The average rhinitis DSS evaluates the treatment effect as the difference in daily rhinitis symptoms score (on a scale from 0-12) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.

    Measured: 4 weeks (primary efficacy assessment period), starting 20-24 weeks after initiation of IMP.

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

    Average rhinitis DMS evaluates the treatment effect as the difference in daily rhinitis medication use (on a scale of 0-12) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.

    Measured: 4 weeks (primary efficacy assessment period), starting 20-24 weeks after initiation of IMP.

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

    Average rhinoconjunctivitis TCS evaluates the treatment effect as the difference in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.

    Measured: 4 weeks (primary efficacy assessment period), starting 20-24 weeks after initiation of IMP.

  4. Average rhinoconjunctivitis DSS during the primary efficacy assessment period

    The average rhinoconjunctivitis DSS evaluates the treatment effect as the difference in daily rhinoconjunctivitis symptom score (on a scale of 0-18) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.

    Measured: 4 weeks (primary efficacy assessment period), starting 20-24 weeks after initiation of IMP.

  5. Average rhinoconjunctivitis DMS during the primary efficacy assessment period

    The average rhinoconjunctivitis DMS evaluates the treatment effect as the difference in daily rhinoconjunctivitis medication use (on a scale of 0-20) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.

    Measured: 4 weeks (primary efficacy assessment period), starting 20-24 weeks after initiation of IMP.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start1 Sep 2025
  3. Primary completion31 Aug 2026
  4. Study completion10 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
327 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07060885
Sponsor's protocol ID
MT-21
Other IDs
2025-000321-14, 2025
Status last verified
Sep 2026
First submitted
1 Jul 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HDM SLIT-tablet (12 SQ-HDM) in people with Allergic Rhinoconjunctivitis and Allergic Rhinitis, run by ALK-Abelló A/S at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period. (time frame: 4 weeks (primary efficacy assessment period), starting 20-24 weeks after initiation of IMP.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07060885.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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