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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04176185
Recruitment Status : Recruiting
First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S

Brief 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.

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Biological: Sublingual allergy immunological tablet Other: Placebo Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Participant, Investigator)
Masking Description: Randomised
Primary Purpose: Treatment
Official Title: A Phase III Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) Sublingual Immunotherapy (SLIT)-Tablet in Adult Chinese Subjects With HDM Allergic Rhinitis/Rhinoconjunctivitis Using an Environmental Exposure Chamber
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : November 7, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Odactra

Arm Intervention/treatment
Experimental: Active
HDM SLIT-tablet once daily for approximately 24 weeks
Biological: Sublingual allergy immunological tablet
For daily administration (1 tablet per day)
Other Names:
  • 12 SQ HDM SLIT-tablet
  • Acarizax

Placebo Comparator: Placebo
Placebo tablet once daily for approximately 24 weeks
Other: Placebo
For daily administration (1 tablet per day)
Other Name: Placebo sublingual tablet




Primary Outcome Measures :
  1. Total Nasal Symptom Score (TNSS) [ Time Frame: Last 4 hours of the EEC session at week 24 ]
    Primary endpoint, average TNSS during the EEC session at week 24, defined as the average of all TNSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 12 (severe symptoms).


Secondary Outcome Measures :
  1. Total Symptom Score (TSS) [ Time Frame: Last 4 hours of the EEC session at week 24 ]
    Key secondary endpoint, average TSS during the EEC session at week 24, defined as the sum of the Total Ocular Symptom Score (TOSS) and TNSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 18 (severe symptoms).


Other Outcome Measures:
  1. Frequency of adverse events [ Time Frame: 26 weeks ]
    Number of Adverse events per treatment group

  2. Assessment of lung function [ Time Frame: 26 weeks ]
    FEV1

  3. Total Ocular Symptom Score (TOSS) [ Time Frame: Last 4 hours of the EEC session at week 24 ]
    Average TOSS during the EEC session at week 24, defined as the average of all TOSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 6 (severe symptoms).

  4. Immunology [ Time Frame: Baseline to 24 weeks ]
    Change from baseline in measurements of house-dust-mite-specific IgG & IgE antibodies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04176185


Contacts
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Contact: Mette K Laursen, MSc +4545747576 clinicaltrials@alk.net
Contact: Martin R Pedersen, MSc +4545747576 clinicaltrials@alk.net

Locations
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Austria
Vienna Challenge Chamber Not yet recruiting
Vienna, Austria, 1150
Contact: René Zieglmayer, CEO         
China
Tongren Hospital Recruiting
Beijing, China
Contact: Lou Zhang, Prof.         
Sponsors and Collaborators
ALK-Abelló A/S
Investigators
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Principal Investigator: Luo Zhang, Prof. Beijing Tongren Hospital
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Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT04176185    
Other Study ID Numbers: MT-16
First Posted: November 25, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ALK-Abelló A/S:
House Dust Mite
Allergic rhinitis
Allergic conjunctivitis
China
Environmental exposure chamber
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctival Diseases
Eye Diseases