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

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.

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.

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