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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65 (NCT07060885) is a Phase 3 interventional studying Allergic Rhinoconjunctivitis and Allergic Rhinitis, sponsored by Alk-Abelló A/S. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Allergic Rhinoconjunctivitis, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 300 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

HDM SLIT-tablet (12 SQ-HDM)

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

OTHER

Placebo

For daily administration (1 tablet per day)

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07060885), the sponsor (Alk-Abelló A/S), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07060885 clinical trial studying?

A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07060885?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07060885?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07060885. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07060885. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.