Phase IIb Study to Assess the Efficacy, Safety and Tolerability of Two Dosing Regimens of AllerT in Comparison to Placebo in Adult Subjects Allergic to Birch Pollen
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 24
- 主要终点
- Combined Rhinoconjunctivitis Symptom and Medication Score
研究概览
简要总结
The main objective of the trial is to demonstrate the efficacy of a two months pre-seasonal treatment with AllerT 100 µg maintenance dose in reducing symptoms of allergic rhinoconjunctivitis during the following birch 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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe allergic rhinoconjunctivitis to birch pollen:
- •Score of symptoms of the Rhinoconjunctivitis Symptom Score (RSS) ≥ 12 during the two preceding birch pollen seasons
- •Previous use of anti-allergy medications during the two preceding birch pollen seasons
- •Positive SPT to birch pollen extract
- •Positive specific IgE CAP test for Bet v 1
排除标准
- •uncontrolled asthma, FEV1 < 80% of predicted
- •previous SIT (specific immunotherapy) to birch pollen or any other SIT within 5 years
- •clinical symptoms due to allergens other than birch pollen during the whole trial period
- •history of anaphylaxis
- •positive skin prick test to AllerT
- •any other treatment or conditions which may increase the risk of the study for the subject or affect the efficacy assessments during the birch pollen season
研究组 & 干预措施
placebo
SC injections of placebo
干预措施: placebo (Drug)
AllerT low dose
SC injections of AllerT 25 or 50 micrograms
干预措施: AllerT low dose (Drug)
AllerT full dose
SC injections of AllerT 50-100 micrograms
干预措施: AllerT full dose (Drug)
结局指标
主要结局
Combined Rhinoconjunctivitis Symptom and Medication Score
时间窗: up to 6 weeks during the birch pollen season 2013
The efficacy analysis will be performed on the symptom and medication data collected from the first day of the birch pollen season as defined by pollen counts in the air in each site region (from March to May 2013 depending on site region), to 42 days later or to the end of the pollen season, whichever comes first. The scale range is from 0 to 3. Lower is the the RSMS value, better is the efficacy as this implies that lower is the symptoms and concomitant medication intake by the patient The RSMS includes 2 subscales : the Rhinoconjunctivitis Symptom Score (RSS) with a range of values from 0 to 3 and the Rhinoconjunctivitis Medication Score Score (RMS) with also a range of values from 0 to 3 The RSMS is the sum of the RSS and RMS divided by 2
次要结局
- Quality of Life(up to 6 weeks during the birch pollen season 2013)
- Safety and Tolerability(from start of treatment to 28 days after completion of treatment, i.e. for approximately 12 weeks)