A Randomised Double-blind Placebo-controlled Phase III Field Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Chinese Participants Aged 12-65 Years With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 327
- 试验地点
- 30
- 主要终点
- Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period.
研究概览
简要总结
A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
详细描述
The trial aims to evaluate efficacy of the house dust mite (HDM) SLIT-tablet compared to placebo in Chinese participants aged 12-65 with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Efficacy will be assessed based on the total combined rhinitis score during the last 4 weeks of treatment.
The trial is a randomised, double-blind, parallel-group, placebo-controlled, multi-site, phase III trial conducted in China. The treatment period will be 24-28 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Chinese subjects aged 12-65 years
- •A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening
- •Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period
- •Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period
- •Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D. farinae at screening
- •Lung function ≥ 70% of predicted value
排除标准
- •Sensitised and regularly exposed to perennial allergens
- •Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation
- •Asthma requiring treatment with high dose of inhaled corticosteroid
- •A relevant history of systemic allergic reaction
研究组 & 干预措施
Active treatment
HDM SLIT-tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
干预措施: HDM SLIT-tablet (12 SQ-HDM) (Biological)
Placebo
Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.
干预措施: Placebo (Other)
结局指标
主要结局
Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period.
时间窗: 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.
The average daily TCRS evaluates the treatment effect as the difference in daily rhinitis symptoms and medication score (on a scale from 0-24) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.
Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period.
时间窗: 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.
The average daily TCRS evaluates the treatment effect as the difference in daily rhinitis symptoms and medication score (on a scale from 0-24) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period.
次要结局
- Average daily values for rhinitis daily symptom score (DSS) during primary efficacy period.(4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.)
- Average daily values for rhinitis daily medication score (DMS) during primary efficacy period.(4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.)
- Average daily total combined score (TCS) during primary efficacy period.(4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.)
- Average rhinoconjunctivitis DSS during the primary efficacy assessment period(4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.)
- Average rhinoconjunctivitis DMS during the primary efficacy assessment period(4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.)
- Average daily values for rhinitis daily symptom score (DSS) during primary efficacy period.(4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.)
- Average daily values for rhinitis daily medication score (DMS) during primary efficacy period.(4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.)
- Average daily total combined score (TCS) during primary efficacy period.(4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.)
- Average rhinoconjunctivitis DSS during the primary efficacy assessment period(4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.)
- Average rhinoconjunctivitis DMS during the primary efficacy assessment period(4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.)