NCT03347279已完成3 期
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents With Severe Uncontrolled Asthma (NAVIGATOR)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,061
- 试验地点
- 290
- 主要终点
- Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma
研究概览
简要总结
A Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults and Adolescents with Severe Uncontrolled Asthma
详细描述
This is a multicentre, randomized, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma on medium to high-dose ICS and at least one additional asthma controller medication with or without OCS. Approximately 1060 subjects will be randomized globally. Subjects 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
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age. 12-80
- •Documented physician-diagnosed asthma for at least 12 months
- •Subjects who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 12 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 (<90% for subjects 12-17 yrs)
- •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.
- •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 subjects with smoking history ≥10 pack-years and subjects using vaping products, including electronic cigarettes.
- •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.
- •Subject randomized in the current study or previous tezepelumab studies.
结局指标
主要结局
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma
时间窗: From randomisation to Study Week 52.
The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. The analysis is based on the primary population (Full Analysis Set)
Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma in Subjects With Baseline Eosinophils < 300 Cells/uL
时间窗: From randomisation to Study Week 52.
The annual exacerbation rate is based on unadjudicated exacerbations reported by the investigator in the eCRF. This analysis is based on subjects with baseline eosinophils \< 300 cells/uL
次要结局
- Mean Change From Baseline at Week 52 in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) (L) (Key Secondary Endpoint)(From randomisation to Study Week 52)
- Mean Change From Baseline at Week 52 in Asthma Symptom Diary (Key Secondary Endpoint)(From randomisation to Study Week 52)
- Mean Change From Baseline at Week 52 in Asthma Control Questionnaire-6(ACQ-6) (Key Secondary Endpoint)(From randomisation to Study Week 52)
- Mean Change From Baseline at Week 52 in Clinic Fractional Exhaled Nitric Oxide (FeNO) (Ppb)(From randomisation to Study Week 52)
- Mean Change From Baseline at Week 52 in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score (Key Secondary Endpoint)(From randomisation to Study Week 52)
- Mean Change From Baseline in Class Productivity Loss Due to Asthma at Week 52(From randomisation to Study Week 52)
- Activity Impairment at Week 52(From randomisation to Study Week 52)
- Patients Global Impression of Change at Week 52(From randomisation to Study Week 52)
- Patients Global Impression of Severity at Week 52(At Study Week 52)
- Number of Participants With Asthma Specific Healthcare Utilization Over 52 Weeks(From randomisation to Study Week 52)
- Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52(From randomisation to Study Week 52)
- Time to First Asthma Exacerbation(From randomisation to Study Week 52)
- Mean Change From Baseline in Work Productivity Loss Due to Asthma at Week 52(From randomisation to Study Week 52)
- Pharmacokinetics of Tezepelumab(Pre-dose samples at Baseline, Week 4, Week 12, Week 24, Week 36, Week 52, Week 64)
- Mean Change From Baseline at Week 52 in EQ-5D-5L VAS(At Study Week 52)
- Clinicians Global Impression of Change at Week 52(From randomisation to Study Week 52)
- Mean Change From Baseline at Week 52 in Total Serum IgE (IU/mL)(From randomisation to Study Week 52)
- Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)(From randomisation to Study Week 52)
- Mean Change From Baseline at Week 52 in Blood Eosinophils (Cells/uL)(From randomisation to Study Week 52)
- Proportion of Subjects Who Had no Asthma Exacerbations(From randomisation to Study Week 52)
- Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 (Weekly Means)(From randomisation to Study Week 52)
- Mean Change From Baseline in Night Time Awakenings (Weekly Means) at Week 52(From randomisation to Study Week 52)
- Immunogenecity of Tezepelumab(Baseline, and from time of first dose at Week 0 to end of study at Week 64.)
- Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalisation(From randomisation to Study Week 52)
- Proportion of Subjects With at Least One Asthma Exacerbation Associated With Emergency Room Visit or Hospitalisation(From randomisation to Study Week 52)
- Proportion of Subjects Who Had no Asthma Exacerbations Associated With Emergency Room or Hospitalisation(From randomisation to Study Week 52)
研究者
研究点 (290)
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