A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Multi-center Study to Evaluate the Efficacy and Safety of GB001 as Maintenance Therapy in Adult Subjects With Moderate to Severe Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 481
- 试验地点
- 115
- 主要终点
- Proportion of Participants Who Experience Worsening of Asthma by Week 24
研究概览
简要总结
A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe asthma and an eosinophilic phenotype with respect to asthma worsening at the end of 24 weeks of treatment.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Placebo once per day (QD) for 24 weeks
干预措施: Placebo (Drug)
GB001 20 mg
GB001 20 mg QD for 24 weeks
干预措施: GB001 (Drug)
GB001 40 mg
GB001 40 mg QD for 24 weeks
干预措施: GB001 (Drug)
GB001 60 mg
GB001 60 mg QD for 24 weeks
干预措施: GB001 (Drug)
结局指标
主要结局
Proportion of Participants Who Experience Worsening of Asthma by Week 24
时间窗: up to Week 24
Proportion of participants who experience worsening of asthma by Week 24 as defined by at least 1 of the following: * On 2 consecutive days, morning (AM) peak expiratory flow (PEF) ≤ 75% of mean AM PEF measured over the last 7 days of the Run-in * Forced expiratory volume in 1 second (FEV1) \< 80% of baseline * Increase in rescue medication use of ≥ 6 puffs/day on 2 consecutive days compared to mean use over the last 7 days of the Run-in * Increase in Asthma Control Questionnaire 5 (ACQ-5; see Outcome Measure 2 for description) score of ≥ 0.5 compared to baseline * The occurrence of a severe asthma exacerbation (asthma attack) defined as deterioration of asthma that leads to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.
次要结局
- Change From Baseline to Week 24 in Morning Peak Expiratory Flow (AM PEF)(Baseline, Week 24)
- Change From Baseline to Week 24 in Asthma Control Questionnaire - 5 (ACQ-5) Score(Baseline, Week 24)
- Annualized Rate of Severe Asthma Exacerbations(up to Week 24)
- Change From Baseline to Week 24 in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)(Baseline, Week 24)
- Time to First Asthma Worsening(up to Week 24)
- Change From Baseline to Week 24 in Post-Bronchodilator FEV1(Baseline, Week 24)
- Percentage of Participants With a Treatment-Emergent Adverse Event (AE)(From first dose of study treatment through Week 28)