A Randomized, Double-Masked, Placebo-Controlled, Multicenter, Dose-Regimen Study of the Efficacy and Safety of TOLAMBA™ in Ragweed-Allergic Rhinitis Adults
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 738
- 试验地点
- 55
- 主要终点
- Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.
研究概览
简要总结
The purpose of this study is to find out if a new investigational vaccine, TOLAMBA™, is safe and effective in reducing the symptoms of ragweed allergy.
详细描述
Ragweed allergy is the most common seasonal allergy in North America. Allergen immunotherapy is a therapeutic option for patients who have allergy symptoms that cannot be adequately controlled by avoidance of the allergen or medication. It may also be appropriate for those who cannot tolerate their medications due to side effects or have difficulties with medication compliance. This study compares the safety and efficacy of two different dosing regimens of TOLAMBA™ with placebo in reducing the symptoms of ragweed-allergic adults over two consecutive ragweed pollen seasons.
Comparison(s): Subject-rated allergy symptoms of subjects treated with TOLAMBA™ dose-intense regimen or TOLAMBA™ lower-dose regimen, compared with subjects treated with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a history of ragweed allergic rhinitis (hayfever) during at least the last 2 consecutive seasons that has required treatment with antihistamines, decongestants and/or nasal steroids, but where symptom relief has been incomplete
- •Is willing to stay in their ragweed area during the historical peak period of the local ragweed season, and willing to travel for no more than 2 weeks (cumulative time) outside of their ragweed area during the entire season
排除标准
- •Has had any hospital admissions for asthma
- •Has smoked within the past year, or has a ≥10-pack per year smoking history
- •Has had any previous immunotherapy with ragweed pollen extract, or was in a previous clinical trial with TOLAMBA™
- •Has used Xolair within the past 12 months
- •Has a history of anaphylaxis
研究组 & 干预措施
1
TOLAMBA™ dose-intense regimen
干预措施: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate (Biological)
2
TOLAMBA™ lower-dose regimen
干预措施: Amb a 1 immunostimulatory oligodeoxyribonucleotide conjugate (Biological)
3
干预措施: Histamine base (Biological)
结局指标
主要结局
Change from baseline in total nasal symptom score during the peak period of the ragweed pollen season.
时间窗: Two years
次要结局
未报告次要终点