NCT00575003已完成2 期
Double-Blind, Placebo-Controlled Study to Investigate an Immunomodulatory Therapy (CYT003-QbG10) in Adult Patients With Perennial Allergic Rhinoconjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 7
- 主要终点
- Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
研究概览
简要总结
The purpose of the study is to test the efficacy of a vaccine against house dust mite and/or cat allergy compared to placebo in adult patients.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate perennial allergic rhinoconjunctivitis due to hypersensitization towards house dust mite and/or cat allergens
排除标准
- •Clinical relevant other allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments.
- •Use of any concomitant medication that could affect the patient's study treatment response or assessment results.
- •Any clinically relevant concomitant disease as judged by the investigator.
- •Pregnancy or female planning to become pregnant during the study.
研究组 & 干预措施
1
Experimental
干预措施: CYT003-QbG10 (Drug)
2
Placebo Comparator
干预措施: CYT003-QbG10 (Drug)
结局指标
主要结局
Conjunctival provocation test with allergen and rhinoconjunctivitis symptoms in daily life
时间窗: on 4 occations over 1 year
次要结局
- Safety and tolerability of the vaccine by collection of adverse events(at each visit)
研究者
研究点 (7)
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