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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Total Nasal Symptom Score (TNSS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomised
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active
HDM SLIT-tablet once daily for approximately 24 weeks
干预措施: Sublingual allergy immunological tablet (Biological)
Placebo
Placebo tablet once daily for approximately 24 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Total Nasal Symptom Score (TNSS)
时间窗: 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).
次要结局
- Total Symptom Score (TSS)(Last 4 hours of the EEC session at week 24)