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

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

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.

Study Overview

• Status: Terminated
• Conditions: Allergic Rhinoconjunctivitis
• Intervention / Treatment: Other: Placebo; Biological: Sublingual allergy immunological tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1150
    • Vienna Challenge Chamber
• China
  • Beijing, China
    • Tongren Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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: Acarizax; 12 SQ HDM SLIT-tablet
PLACEBO_COMPARATOR: Placebo; Placebo tablet once daily for approximately 24 weeks	Other: Placebo; For daily administration (1 tablet per day); Other Names: Placebo sublingual tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Last 4 hours of the EEC session at week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Last 4 hours of the EEC session at week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events	Number of Adverse events per treatment group	26 weeks
Assessment of lung function	FEV1	26 weeks
Total Ocular Symptom Score (TOSS)	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).	Last 4 hours of the EEC session at week 24
Immunology	Change from baseline in measurements of house-dust-mite-specific IgG & IgE antibodies	Baseline to 24 weeks

Collaborators and Investigators

• Sponsor: ALK-Abelló A/S
• Investigators: Principal Investigator: Luo Zhang, Prof., Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 4, 2019
• Primary Completion (ACTUAL): December 17, 2019
• Study Completion (ACTUAL): January 19, 2022

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (ACTUAL): November 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: China; Allergic conjunctivitis; Allergic rhinitis; House Dust Mite; Environmental exposure chamber
• Additional Relevant MeSH Terms: Eye Diseases; Conjunctival Diseases; Conjunctivitis
• Other Study ID Numbers: MT-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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