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

Phase 3

Terminated

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Other: Placebo; Biological: Sublingual allergy immunological tablet

• Registration Number: NCT04176185
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-10-25
• Study Start: 2019-11-04
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-25
• Primary Completion: 2019-12-17
• Status Verified: 2021-02
• Study Completion: 2022-01-19
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo tablet once daily for approximately 24 weeks
Active	Sublingual allergy immunological tablet	HDM SLIT-tablet once daily for approximately 24 weeks

Primary Outcome Measures

Name	Time	Method
Total Nasal Symptom Score (TNSS)	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

Name	Time	Method
Total Symptom Score (TSS)	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).

Trial Locations

Locations (2)

Tongren Hospital; 🇨🇳 Beijing, China

Vienna Challenge Chamber; 🇦🇹 Vienna, Austria