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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Allergic Rhinoconjunctivitis
- Sponsor
- ALK-Abelló A/S
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Total Nasal Symptom Score (TNSS)
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- Total Symptom Score (TSS)(Last 4 hours of the EEC session at week 24)