NCT02795273撤回2 期
A Combined Phase 2b/3, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study to Assess the Efficacy and Safety of Grass-SPIRE in Subjects With Grass Pollen-Induced Allergic Rhinitis, With or Without Conjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Safety of Grass-SPIRE
研究概览
简要总结
The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication during the grass pollen season
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 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical history of grass pollen-induced allergic rhinitis with or without conjunctivitis for at least 2 years
- •Score of ≤ 21 on RCAT questionnaire
- •Rye grass specific IgE of ≥ 0.7 kU/L
- •Positive skin prick test to Rye grass whole allergen extract
排除标准
- •History or findings of significant disease
- •Asthma requiring GINA Step 3 or higher treatment
- •History of severe drug allergy, severe angioedema or systemic allergic reaction
- •Course of short-duration allergy-specific immunotherapy or more than 3 months treatment with long-duration allergen immunotherapy within 5 years
- •Contraindications for administration of epinephrine
研究组 & 干预措施
Grass-SPIRE
Experimental
Eight intradermal injections of Grass-SPIRE
干预措施: Grass-SPIRE (Drug)
Placebo
Placebo Comparator
Eight intradermal injections of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Safety of Grass-SPIRE
时间窗: Approximately 66 weeks
Measurement of adverse events
Combined Score of symptoms and allergy medication
时间窗: Approximately 66 weeks
Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication
次要结局
- Symptom Scores(Approximately 66 weeks)
- Rescue Medication Use(Approximately 66 weeks)
- Quality of Life(Approximately 66 weeks)
研究者
研究点 (1)
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