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

Allergic Rhinoconjunctivitis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04176185
• Other study ID #: MT-16
• Status: Terminated
• Phase: Phase 3
• Start date: November 4, 2019
• Est. completion date: January 19, 2022

Study information

• Verified date: February 2021
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: January 19, 2022
• Est. primary completion date: December 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis

Intervention

Biological:
• Sublingual allergy immunological tablet
For daily administration (1 tablet per day)

Other:
• Placebo
For daily administration (1 tablet per day)

Locations

Country	Name	City	State
Austria	Vienna Challenge Chamber	Vienna
China	Tongren Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Countries where clinical trial is conducted

Austria,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of adverse events	Number of Adverse events per treatment group	26 weeks
Other	Assessment of lung function	FEV1	26 weeks
Other	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
Other	Immunology	Change from baseline in measurements of house-dust-mite-specific IgG & IgE antibodies	Baseline to 24 weeks
Primary	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	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