An Optional One Year Follow-up Study to Evaluate the Continued Efficacy of ToleroMune Ragweed in Ragweed Allergic Subjects Following Challenge With Ragweed Allergen in an Environmental Exposure Chamber.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Total Rhinoconjunctivitis Symptom Score
研究概览
简要总结
Ragweed is the primary cause of autumn allergies. The ragweed season begins in mid-August. In the third National Health and Nutrition Examination Surveys54.3% of the population had positive test responses to one or more allergens, with the prevalence for short ragweed being 26.2%
The purpose of this observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to ragweed allergen in the EEC among subjects who completed all dosing visits and the post treatment challenge (PTC) visit in study TR002 approximately one year after the start of treatment.
详细描述
Subjects who were randomised in study TR002 and who completed all dosing visits and the PTC will be invited to attend the Screening Visit for TR002B. Subjects will attend the EEC for 4 visits on successive days. Following the final EEC visit a follow-up visit will be performed 3-10 days later.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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: 48-54 weeks after the start of treatment in TR002
次要结局
- Total nasal and non-nasal symptom scores(48-54 weeks after the start of treatment in TR002)
- Change in Immunoglobulin A (IgA)(50-56 weeks after the start of treatment in Tr002)
- Change in Immunoglobulin E (IgE)(50-56 weeks after the start of treatment in Tr002)
- Change in Immunoglobulin G4 (IgG4)(50-56 weeks after the start of treatment in Tr002)
- Adverse Events(50-56 weeks after the start of treatment in TR002)