JPRN-jRCT2080222528已完成Unknown
Phase II/III clinical trial of TO-206 - Evaluation of efficacy and safety in patients with Japanese cedar pollinosis
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 1,042
研究概览
简要总结
This study results demonstrated the superiority of three active doses of TO-206 2,000 JAU, 5,000 JAU and 10,000 JAU to placebo. 5,000 and 10,000 JAU indicated the same degree of efficacy and statistically significant differences to 2,000 JAU was revealed. The optimal dose was determined to be 5,000 JAU. The effect of TO-206 5,000 JAU was maintained for 2 years after the end of administration. TO-206 5,000 JAU showed favorable safety profile.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 5age old 至 <= 64age old（—）
- 性别
- All
入选标准
- •1)Patients with specific IgE against cedar pollen : class 3 or more.
- •2)Patients who have a clinical history of cedar pollinosis in 2013 and 2014 cedar pollen seasons.
排除标准
- •1)Patients with perennial allergic rhinitis, medication-derived rhinitis, vasomotor rhinitis or non-allergic rhinitis during therapy.
- •2)Patients who have developed asthmatic attack within 5 years before the pre-treatment observation visit.
- •3)Patients who have received specific immunotherapy for cedar pollinosis in history.
研究者
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