A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 856
- 试验地点
- 236
- 主要终点
- Annualised Asthma Exacerbation Rate (AAER) up to Week 52
研究概览
简要总结
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
详细描述
This is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate efficacy and safety of tralokinumab administered subcutaneously in subjects with uncontrolled asthma on inhaled corticosteroid plus long-acting β2-agonist and having a history of asthma exacerbations. Approximately 770 subjects will be randomized globally. Subjects will receive tralokinumab, or placebo, administered via subcutaneous injection at the study site, over a 52-week treatment period.
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)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented physician-diagnosed asthma.
- •Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
- •Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of age) of their PNV.
- •Post-BD reversibility of ≥12% and ≥200 mL in FEV1
- •ACQ-6 score ≥1.5
排除标准
- •Pulmonary disease other than asthma
- •History of anaphylaxis following any biologic therapy
- •Hepatitis B, C or HIV
- •Pregnant or breastfeeding
- •History of cancer
- •Current tobacco smoking or a history of tobacco smoking for ≥ 10 pack-years
- •Previous receipt of tralokinumab
研究组 & 干预措施
Tralokinumab
Tralokinumab subcutaneous injection
干预措施: Experimental: Tralokinumab (Biological)
Placebo
Placebo subcutaneous injection
干预措施: Placebo (Other)
结局指标
主要结局
Annualised Asthma Exacerbation Rate (AAER) up to Week 52
时间窗: Baseline (Week 0) up to Week 52
Asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room (ER) or urgent care (UC) visit (defined as evaluation and treatment for \<24 hours in an ER or UC centre) due to asthma that required systemic corticosteroids (see above). * An inpatient hospitalisation (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma. AAER = number of exacerbations\*365.25 / (follow-up date - date of randomisation + 1) (where maximum follow-up time for a patient was approximately 52 weeks). AAER in the tralokinumab group was compared to that seen in the placebo group up to Week 52 using a negative binomial model; rate ratios and rate reductions are both presented for comparative statistical analyses.
次要结局
- Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)(Baseline (Week 0) and Week 52)
- Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means)(Baseline (Week 0) and Week 52)
- Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score(Baseline (Week 0) and Week 52)
- Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score(Baseline (Week 0) and Week 52)
- AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52(Baseline (Week 0) up to Week 52)
- Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52(Baseline (Week 0) and Week 52)
- Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means)(Baseline (Week 0) and Week 52)
- Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52(Baseline (Week 0) and Week 52)
- Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage])(Baseline (Week 0) and Week 52)
- Number of Patients With ≥1 Asthma Exacerbation up to Week 52(Baseline (Week 0) up to Week 52)
- Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52(At Week 52)
- WPAI+CIQ: Activity Impairment at Week 52(At Week 52)
- Asthma-related Healthcare Encounters by Type up to Week 52(Baseline (Week 0) up to Week 52)
- Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations(Baseline (Week 0) up to Week 52)
- Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry(Baseline (Week 0) up to Week 52)
- Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72(Blood samples were collected pre-dose at Baseline (Week 0), and at Week 2, Week 8, Week 26, Week 56 (follow-up) and Week 72 (follow-up))
- Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential(Baseline (Week 0), Week 26, Week 56 (follow-up) and Week 72 (follow-up))