A Double-blind, Randomised, Placebo-controlled Study to Evaluate Three Doses of ToleroMune HDM in House Dust Mite Allergic Subjects Following Challenge With House Dust Mite Allergen in an Environmental Exposure Chamber.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Total Rhinoconjunctivitis Symptom Score
研究概览
简要总结
House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.
ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of HDM allergy
This study will look at the efficacy, safety and tolerability of three doses of ToleroMune HDM in HDM allergic subjects following challenge with HDM allergen in an Environmental Exposure Chamber (EEC)).
详细描述
This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune HDM in HDM allergic subjects with allergic rhinoconjunctivitis. The efficacy of ToleroMune Ragweed will be explored in subjects using an EEC.
The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 16 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 3 visits to the EEC. Eligible subjects will complete a daily diary card at home for two weeks following the final visit to the EEC.
In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of four groups and will receive treatment over 11 visits in 3 dosing periods for each subject. Within each dosing period visits will take place at intervals of 4 weeks (28±2 days). There will also be two EEC visits during the treatment period and one post treatment EEC visit. Following the final visit to the EEC, subjects will complete a daily diary card at home for two weeks.
In Period 3, Follow-up will be conducted 16-21 days after the final EEC visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Total Rhinoconjunctivitis Symptom Score
时间窗: Up to 47 weeks
次要结局
- Symptom scores for nasal and non-nasal symptoms(Up to 47 weeks)
- Total Rhinoconjunctivitis Symptom Score(Up to 36 weeks)
- HDM specific IgA(Up to 53 weeks)
- HDM specific IgE(Up to 53 weeks)
- HDM specific IgG4(Up to 53 weeks)
- Adverse Events(Upto 53 weeks)