NCT07219173招募中2 期
A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 531
- 试验地点
- 223
- 主要终点
- Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma.
Study participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.
- •Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.
- •History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •An established diagnosis of occupational asthma
- •Known pre-existing, clinically important lung condition other than asthma, including but not limited to:
- •chronic respiratory infection
- •bronchiectasis
- •pulmonary fibrosis
- •allergic bronchopulmonary aspergillosis
- •emphysema
- •chronic bronchitis
- •eosinophilic granulomatosis with polyangiitis
- •chronic obstructive pulmonary disease, and
- •other mimics of asthma, that is, vocal cord dysfunction.
- •Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.
研究组 & 干预措施
Brenipatide Dose 2
Experimental
Brenipatide administered SC.
干预措施: Brenipatide (Drug)
Placebo
Placebo Comparator
Placebo administered SC.
干预措施: Placebo (Drug)
Brenipatide Dose 1
Experimental
Brenipatide administered subcutaneously (SC)
干预措施: Brenipatide (Drug)
结局指标
主要结局
Annualized Asthma Exacerbation Rate Over 52 Weeks of Treatment
时间窗: Baseline to Week 52
To assess the asthma exacerbation rate.
次要结局
- Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in One Second (FEV1)(Baseline, Week 52)
- Change from Baseline in Patient Reported Health Outcomes(Baseline, Week 52)
- Time to First Exacerbation(Baseline to Week 52)
- Change from Baseline in Weekly Mean Rescue Medication Use(Baseline, Week 52)
- Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide(Baseline up to Week 52)
- Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)(Baseline to Week 52)
研究者
研究点 (223)
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