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A Research Study in Chinese People With Allergy to House Dust Mites, Using an Environmental Exposure Chamber

Study Purpose

This trial evaluates the efficacy and safety of HDM SLIT-tablet in treatment of HDM AR. The efficacy is evaluated using an environmental exposure chamber (EEC). Subjects will be randomised to receive treatment with HDM SLIT-tablet and placebo 1:1.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria.

  • - Male or female Chinese subjects aged ≥18 years.
  • - A clinical history of HDM AR/C with or without asthma.
  • - Positive SPT and IgE to Der p or Der f at screening.
  • - A TNSS of at least 6 of 12 within the first 2 hours of the screening EEC session prior to randomisation.
Exclusion criteria.
  • - Sensitised and regularly exposed perennial or seasonal allergens.
  • - Asthma requiring treatment with high-dose ICS.
  • - Reduced lung function.
  • - Has a nasal condition that could confound the efficacy or safety assessment.
- A relevant history of systemic allergic reaction

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

ALK-Abelló A/S
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Luo Zhang, Prof.
Principal Investigator Affiliation Beijing Tongren Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Austria, China

The disease, disorder, syndrome, illness, or injury that is being studied.

Allergic Rhinoconjunctivitis
Additional Details

This trial is a 24 weeks, randomised, parallel-group, double-blind, placebo-controlled phase III trial. Approximately 202 subjects will be randomised (1:1) to receive treatment with HDM SLIT-tablet or placebo. The trial will be conducted in China, with subjects recruited and treated in China. Two EEC assessments (baseline and end of treatment) will take place at a validated EEC facility in Austria. The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet (12 SQ-HDM) once daily compared to placebo in the treatment of HDM AR nasal symptom determined during the EEC session at week 24.

Arms & Interventions


Experimental: Active

HDM SLIT-tablet once daily for approximately 24 weeks

Placebo Comparator: Placebo

Placebo tablet once daily for approximately 24 weeks


Biological: - Sublingual allergy immunological tablet

For daily administration (1 tablet per day)

Other: - Placebo

For daily administration (1 tablet per day)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Vienna Challenge Chamber, Vienna, Austria


Not yet recruiting


Vienna Challenge Chamber

Vienna, , 1150

Site Contact

René Zieglmayer, CEO



Tongren Hospital, Beijing, China




Tongren Hospital

Beijing, ,

Site Contact

Lou Zhang, Prof.



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