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

  • STATUS
    Recruiting
  • days left to enroll
    67
  • participants needed
    202
  • sponsor
    ALK-Abelló A/S
Updated on 19 February 2022
asthma
environmental exposure

Summary

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.

Description

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.

Details
Condition Allergic Rhinoconjunctivitis
Treatment Placebo, Sublingual allergy immunological tablet
Clinical Study IdentifierNCT04176185
SponsorALK-Abelló A/S
Last Modified on19 February 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note