A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Efficacy and Safety of TEV-48574 in Adults With T2-low/Non-T2 Severe Uncontrolled Asthma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 97
- 主要终点
- Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period
研究概览
简要总结
The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA).
The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control.
The duration of participant participation in the study is planned to be up to approximately 30 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has a diagnosis of asthma for at least 12 months prior to the initial screening visit.
- •The participant is able to perform technically acceptable and repeatable spirometry, including with a hand-held spirometer, after training
- •The participant has had at least one documented clinical asthma exacerbation in the 18 months prior to (but not within 30 days of) the initial screening visit.
- •The participant is a non-smoker for ≥6 months with lifetime history ≤10 pack-years, with no current ecigarette or marijuana use.
- •NOTE- Additional criteria apply, please contact the investigator for more information
排除标准
- •The participant has any concomitant conditions or treatments that could interfere with study conduct.
- •The participant is currently pregnant or lactating or is planning to become pregnant during the study.
- •The participant has received any live or attenuated vaccine within 15 days of the initial screening visit.
- •NOTE- Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
TEV-48574
Participants will receive the investigational medicinal product (IMP) loading doses on the day of randomization and the subsequent corresponding IMP maintenance doses every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses).
干预措施: TEV-48574 (Drug)
Placebo
Participants will receive placebo matching to TEV-48574 SC every 2 weeks for a total of 8 doses.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Who Experienced Loss of Asthma Control (LoAC) During the Treatment Period
时间窗: From randomization (Week 0) until Week 16
The LoAC was defined as any 1 of the following during the treatment period: - morning peak expiratory flow (PEF) decrease ≥30% from baseline on 2 consecutive days or morning handheld forced expiratory volume in the first second of exhalation (FEV1) decrease ≥20% from baseline on 2 consecutive days; - increase in short-acting beta-agonist (SABA)/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in inhaled corticosteroids (ICS) dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma emergency room (ER) visit or hospitalization.
次要结局
- Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16(Baseline, Week 16)
- Time From Randomization to First CAE During the Treatment Period for Participants With CAE(From randomization (Week 0) until Week 16)
- Time From Randomization to LoAC During the Treatment Period(From randomization (Week 0) until Week 16)
- Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16(Baseline, Week 16)
- Change From Baseline in Percent Predicted Forced Expiratory Volume in the First Second (FEV1) at Week 16(Baseline, Week 16)
- Number of Participants Who Had a Clinical Asthma Exacerbation (CAE) During the Treatment Period(From randomization (Week 0) until Week 16)
- Change From Baseline in Forced Vital Capacity (FVC) at Week 16(Baseline, Week 16)
- Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16(Baseline, Week 16)
- Percent Change in ICS Dose During the Treatment Period(From randomization (Week 0) until Week 16)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)(From randomization (Week 0) until Week 24)
- Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16(Baseline, Week 16)
- Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16(Baseline, Week 16)