NCT06932263招募中2 期
A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 540
- 试验地点
- 229
- 主要终点
- Annualised rate of severe asthma exacerbations
研究概览
简要总结
This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated written informed consent prior to any study-specific procedures.
- •Adults aged 18-75, inclusive when signing the informed consent.
- •Documented physician-diagnosis of asthma for at least 12 months.
- •Treated with medium or high dose ICS in combination with LABA.
- •Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
- •Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
- •Documented exacerbation history in the last 12 months and biomarker requirements of:
- •≥ 2 severe exacerbations OR
- •1 severe exacerbation and:
- •(i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
- •Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
- •Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
- •Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
排除标准
- •Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit
- •Clinically significant pulmonary disease other than asthma .
- •Current smokers, former smokers with >10 pack-years history.
- •Clinically significant aortic stenosis or pulmonary arterial hypertension.
- •Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
- •Unstable cardiovascular disorders.
研究组 & 干预措施
Placebo
Placebo Comparator
Dosing subcutaneously with equivalent volume to tozorakimab
干预措施: Placebo (Drug)
Tozorakimab Dose 1
Experimental
Dosing subcutaneously tozorakimab Dose 1
干预措施: Tozorakimab (Drug)
Tozorakimab Dose 2
Experimental
Dosing subcutaneously tozorakimab Dose 2 and placebo
干预措施: Tozorakimab (Drug)
结局指标
主要结局
Annualised rate of severe asthma exacerbations
时间窗: Over 26 to 52 weeks
The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and ≥ 1 severe exacerbation within 12 months prior to screening.
次要结局
- Anti-drug antibody incidence(Over 52 weeks)
- Annualised rate of severe asthma exacerbations(Over 26 to 52 weeks)
- Time to first severe asthma exacerbation(Over 26 to 52 weeks)
- Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)(Over weeks 20 to 26)
- Change from baseline in post-bronchodilator FEV1(At week 26)
- Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6)(At week 26)
- Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ12+)(At week 26)
- Trough serum concentrations of tozorakimab(Over 52 weeks)
研究者
研究点 (229)
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