EUCTR2014-004932-20-BE进行中（未招募）1 期
A phase IIa, randomized, double-blind, placebo controlled, parallel group study to assess the safety and efficacy of subcutaneously administered BI 655066 (risankizumab) as add-on therapy over 24 weeks in patients with severe persistent asthma.
SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 200 人开始时间: 2015年4月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Pre-bronchodilator clinic measured FEV1 between 40% and 85% of predicted normal.
- •2. One year history of asthma diagnosed by a physician, and have FEV1 reversibility of 12% and an absolute change of at least 200 mL after administration of 400 µg salbutamol.
- •3. Must be on at least medium dose inhaled corticosteroids and at least one other asthma controller medication for at least one year.
- •4. Must have documented history of two or more severe asthma exacerbations in the last 12 months or one severe asthma exacerbation
- •in the last 12 months with hospitalization or one exacerbation in the last
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Patients with a significant disease other than asthma.
- •2. Patients who are not able to produce sputum or sputum samples of sufficient quality.
- •3. Patients who had clinically relevant history of intubation for asthma exacerbation in the past year.
- •4. Patients diagnosed with any concurrent respiratory disease.
- •5. Recent history (within 6 months) of myocardial infarction or hospitalized for cardiac failure in the past year.
- •6. Patients who have undergone thoracotomy with pulmonary resection.
- •7. Patients who have undergone bronchial thermoplasty or radiotherapy procedure in the past year or have planned procedures during the study.
- •8. Patients taking oral corticosteroids with a total daily dose of more than 20 mg prednisone (or equivalent) in the past 6 weeks.
- •9. Pregnant or nursing women.
- •10. Women of childbearing potential that, if sexually active, is unwilling to use a highly effective method of birth control.
- •11. Clinically relevant acute infections or chronic infections.
- •12. Have received any live bacterial or live viral vaccination in the last12 weeks.
- •13. Have received Bacille Calmette-Guerin (BCG) vaccination in the last 12 months.
- •14. Have received treatment with ustekinumab (Stelara®).
- •15. Have received treatment with any other biologics in the last 3 months or within 6 times the half-life of the compound.
- •16. History of allergy or hypersensitivity to biologic agent or its excipients, or hypersensitivity to beta-adrenergic medications.
研究者
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