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

Primary Purpose

Allergic Rhinoconjunctivitis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sublingual allergy immunological tablet
Placebo
Sponsored by
ALK-Abelló A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring House Dust Mite, Allergic rhinitis, Allergic conjunctivitis, China, Environmental exposure chamber

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vienna Challenge Chamber
  • Tongren Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

HDM SLIT-tablet once daily for approximately 24 weeks

Placebo tablet once daily for approximately 24 weeks

Outcomes

Primary Outcome Measures

Total Nasal Symptom Score (TNSS)
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

Total Symptom Score (TSS)
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).

Full Information

First Posted
October 25, 2019
Last Updated
June 27, 2022
Sponsor
ALK-Abelló A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04176185
Brief Title
A Research Study in Chinese People With Allergy to House Dust Mites, Using an Environmental Exposure Chamber
Acronym
QUEST
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
COVID-19
Study Start Date
November 4, 2019 (Actual)
Primary Completion Date
December 17, 2019 (Actual)
Study Completion Date
January 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinoconjunctivitis
Keywords
House Dust Mite, Allergic rhinitis, Allergic conjunctivitis, China, Environmental exposure chamber

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantInvestigator
Masking Description
Randomised
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
HDM SLIT-tablet once daily for approximately 24 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet once daily for approximately 24 weeks
Intervention Type
Biological
Intervention Name(s)
Sublingual allergy immunological tablet
Other Intervention Name(s)
12 SQ HDM SLIT-tablet, Acarizax
Intervention Description
For daily administration (1 tablet per day)
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo sublingual tablet
Intervention Description
For daily administration (1 tablet per day)
Primary Outcome Measure Information:
Title
Total Nasal Symptom Score (TNSS)
Description
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).
Time Frame
Last 4 hours of the EEC session at week 24
Secondary Outcome Measure Information:
Title
Total Symptom Score (TSS)
Description
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).
Time Frame
Last 4 hours of the EEC session at week 24
Other Pre-specified Outcome Measures:
Title
Frequency of adverse events
Description
Number of Adverse events per treatment group
Time Frame
26 weeks
Title
Assessment of lung function
Description
FEV1
Time Frame
26 weeks
Title
Total Ocular Symptom Score (TOSS)
Description
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).
Time Frame
Last 4 hours of the EEC session at week 24
Title
Immunology
Description
Change from baseline in measurements of house-dust-mite-specific IgG & IgE antibodies
Time Frame
Baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luo Zhang, Prof.
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Challenge Chamber
City
Vienna
ZIP/Postal Code
1150
Country
Austria
Facility Name
Tongren Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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