NCT02772419已完成2 期
A Phase 2, Double-Blind, Placebo-Controlled Study of Benralizumab (KHK4563) in Patients With Eosinophilic Chronic Rhinosinusitis
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
- 63
- 主要终点
- The change from baseline in nasal polyp score at Week 12
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of SC administrations of Benralizumab or Placebo in the subjects with Eosinophilic Chronic Rhinosinusitis in a multicenter, randomized, double-blind, placebo-controlled study. The pharmacokinetics and immunogenicity will be assessed secondarily.
详细描述
Screening Period (maximum 4 weeks) , Randomized Treatment Period (24 weeks)
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 20 years to 75 years of age
- •Eosinophilic chronic rhinosinusitis with a total score of ≥ 11 according to the diagnosis of eosinophilic chronic rhinosinusitis at enrollment
- •A minimum bilateral nasal polyp score of 3 out of the maximum score of 8 (with a score of at least 1 out of the maximum score of 4 for each nostril) at screening and at enrollment
- •Weight of ≥ 40 kg at screening
排除标准
- •A Sino-Nasal Outcome Test-22 (SNOT-22) score of < 7 at enrollment
- •Any nasal surgery (including polypectomy) within 1 year prior to the date of consent
- •Hospitalization for ≥ 24 hours for treatment of asthma exacerbation, within 12 weeks prior to the date of consent
- •Exposure to any commercially available (e.g., omalizumab) or investigational biologic agent within 16 weeks or 5 half-lives prior to enrollment, whichever is longer
- •Use of systemic corticosteroids (including oral corticosteroids) or corticosteroid nasal solution (except spraying) within 4 weeks prior to enrollment or planned use of such medications during the double-blind period
- •Prior treatment with benralizumab
研究组 & 干预措施
benralizumab A
Experimental
Subcutaneous (SC) administration
干预措施: benralizumab (Drug)
benralizumab B
Experimental
SC administration
干预措施: benralizumab (Drug)
Placebo
Placebo Comparator
Placebo SC administration
干预措施: Placebo (Drug)
结局指标
主要结局
The change from baseline in nasal polyp score at Week 12
时间窗: baseline and 12 weeks post-dose
次要结局
- The change from baseline in the improvement of olfactory dysfunction(Pre-dose and 4,8,12,24 weeks post-dose)
- The change from baseline in nasal polyp score(Pre-dose and 4,8,12,16,20,24 weeks post-dose)
- The change from baseline in Computed tomography (CT) score(baseline and 12 weeks post-dose)
- Incidence of treatment-emergent adverse events (TEAEs) or drug-related TEAEs and their nature(Up to 24 weeks after dosing)
- Number of subjects discontinued from the study due to aggravation of eosinophilic chronic rhinosinusitis(Up to 24 weeks after dosing)
- Time to discontinuation (days) from the study due to aggravation of eosinophilic chronic rhinosinusitis(Up to 24 weeks after dosing)
- The change from baseline in the averaged values of the Olfactory thresholds(Pre-dose and 4,8,12,24 weeks post-dose)
- The change from baseline in Sino-Nasal Outcome Test-2 (SNOT-22)(Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose)
- The change from baseline in Blood eosinophil count(Pre-dose and 4,8,12,16,20,24 weeks post-dose)
- The change from baseline in Nasal Airway Resistance(Pre-dose and 4,8,12,24 weeks post-dose)
- The change from baseline in Symptom score by Visual Analog Scale (VAS)(Pre-dose and 4,8,12, 16, 20, 24 weeks post-dose)
研究者
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