NCT03927157已完成3 期
A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults With Severe Uncontrolled Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 405
- 试验地点
- 1
- 主要终点
- Annual Asthma Exacerbation Rate (AERR)
研究概览
简要总结
A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Severe Uncontrolled Asthma
详细描述
This is a regional, multicentre, randomized, double-blind, placebo controlled, parallel group, phase 3 study designed to evaluate the efficacy and safety of 210 mg Q4W (SC) of tezepelumab in adults with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 396 participants will be randomized regionally (China/non-China). Participants will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12 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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age. 18-80
- •Documented physician-diagnosed asthma for at least 12 months
- •Participants who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 6 months.
- •Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
- •At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
- •Morning pre-BD FEV1 <80% predicted normal
- •Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
- •Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
- •ACQ-6 score ≥1.5 at screening and on day of randomization
排除标准
- •Pulmonary disease other than asthma.
- •History of cancer.
- •History of a clinically significant infection.
- •Current smokers or participants with smoking history ≥10 pack-yrs.
- •History of chronic alcohol or drug abuse within 12 months.
- •Hepatitis B, C or HIV.
- •Pregnant or breastfeeding.
- •History of anaphylaxis following any biologic therapy.
- •participant randomized in the current study or previous tezepelumab studies.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo: Placebo subcutaneous injection
干预措施: Placebo (Other)
结局指标
主要结局
Annual Asthma Exacerbation Rate (AERR)
时间窗: Randomization to Week 52
The annual exacerbation rate is based on exacerbations reported by the investigator in the eCRF over 52 weeks
次要结局
- Mean Change From Baseline in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at Week 52(Randomization to Week 52)
- Mean Change From Baseline in Weekly Mean Daily Asthma Symptom Diary Score at Week 52(Randomization to Week 52)
- Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score at Week 52(Randomization to Week 52)
- Mean Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score at Week 52(Randomization to Week 52)
- Time to First Asthma Exacerbation(Randomization to Week 52)
- Mean Change From Baseline in Fractional Exhaled Nitric Oxide at Week 52(Randomization to Week 52)
- Number of Participants With Asthma Specific Resource Utilization Over 52 Weeks(Randomization to Week 52)
- Pharmacokinetics of Tezepelumab(Baseline, Week 24, Week 52, Week 64)
- Mean Change From Baseline in EQ-5D-5L VAS Score at Week 52(At Week 52)
- Mean Change From Baseline in Blood Eosinophils (Cells/uL) at Week 52(Randomization to Week 52)
- Mean Change From Baseline in Total Serum IgE (IU/mL) at Week 52(Randomization to Week 52)
- Mean Change From Baseline in Night Time Awakenings (Percentage) at Week 52(Randomization to Week 52)
- Immunogenicity of Tezepelumab(Baseline to Week 64)
- Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52(Randomization to Week 52)
- Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52(Randomization to Week 52)
- Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52(Randomization to Week 52)
- Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalization(Randomization to Week 52)
- Proportion of Participants Who Had no Asthma Exacerbations(Randomization to Week 52)
研究者
研究点 (1)
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