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House dust mite SLIT-tablet for Chinese patients aged 12–65 with dust mite allergy

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

Phase 3 Interventional ALK-Abelló A/S · NCT07060885

This trial will test whether a daily under‑the‑tongue (SLIT) tablet for house dust mite allergy helps Chinese people aged 12–65 who have allergic rhinitis or rhinoconjunctivitis, with or without asthma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment300 (estimated)
Ages12 Years to 65 Years
SexAll
SponsorALK-Abelló A/S Industry-sponsored
Locations30 sites (Beijing, Beijing Municipality and 29 other locations)
Trial IDNCT07060885 on ClinicalTrials.gov

What this trial studies

This is a randomized, double‑blind, parallel‑group, placebo‑controlled Phase 3 trial run at multiple sites in China comparing a 12 SQ‑HDM SLIT‑tablet to placebo over a 24–28 week treatment period. Participants are Chinese males or females aged 12–65 with confirmed sensitization to Dermatophagoides pteronyssinus or D. farinae, a history of HDM allergic rhinitis/rhinoconjunctivitis, and recent symptoms despite using allergy medications. The primary efficacy measure is the total combined rhinitis score during the last four weeks of treatment, with safety and medication use also monitored. Study visits occur at participating hospitals in Beijing and Fuzhou.

Who should consider this trial

Good fit: Ideal candidates are Chinese individuals aged 12–65 with confirmed HDM sensitization (positive skin prick test and specific IgE), persistent AR/C symptoms despite pharmacotherapy, and lung function ≥70% predicted.

Not a fit: Those unlikely to benefit include people regularly exposed to other perennial allergens to which they are sensitized, patients with nasal or pharyngeal conditions that interfere with evaluation, those with severe asthma needing high‑dose inhaled corticosteroids, or people with a history of systemic allergic reactions.

Why it matters

Potential benefit: If successful, the tablet could reduce nasal and eye allergy symptoms and lower the need for daily symptomatic medications in people with dust mite allergy.

How similar studies have performed: Previous randomized trials of HDM sublingual immunotherapy, including phase 3 programs in other regions, have shown efficacy for reducing HDM‑driven allergic rhinitis symptoms, so this approach is supported by prior evidence.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Beijing, Beijing Municipality and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Allergic RhinoconjunctivitisAllergic Rhinitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.