NCT04176185

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: ALK-Abelló A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
BIOLOGICAL	Sublingual allergy immunological tablet	For daily administration (1 tablet per day)
OTHER	Placebo	For daily administration (1 tablet per day)

Timeline

• Start date: 2019-11-04
• Primary completion: 2019-12-17
• Completion: 2022-01-19
• First posted: 2019-11-25
• Last updated: 2022-06-30

Locations

2 sites across 2 countries: Austria, China