NCT07780656招募中3 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants 40 to 80 Years of Age With Moderate to Very Severe COPD (PERSIST COPD-2)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 624
- 试验地点
- 4
- 主要终点
- Annualized rate of moderate or severe COPD Exacerbations
研究概览
简要总结
The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.
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)
盲法说明
This is a double-blind study
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or eligible female participants.
- •Participants with >=40 to less than or equal to (<=) 80 years of age.
- •An eosinophilic phenotype with elevated BEC.
- •Moderate to very severe COPD with frequent exacerbations.
- •Participants with elevated COPD assessment test (CAT) score.
- •Current or former cigarette smokers.
- •On triple (Inhaled corticosteroid [ICS]+ Long-acting muscarinic antagonist [LAMA]+ Long-acting beta-agonist [LABA]) or dual inhaled COPD therapy, if ICS is considered not appropriate.
排除标准
- •Current or prior physician diagnosis of asthma.
- •Other clinically significant lung disease.
- •Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit
- •Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.
- •Continuous oxygen therapy (more than 16 hours/ day).
- •Cor pulmonale resulting in right heart failure and severe pulmonary hypertension.
- •A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).
- •Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.
- •New York Heart Association class III or IV heart failure.
- •Other significant medical conditions that could impact participants' safety or study outcomes.
研究组 & 干预措施
Participants receiving GSK5784283 plus standard of care
Experimental
干预措施: Standard of care (Drug)
Participants receiving GSK5784283 plus standard of care
Experimental
干预措施: GSK5784283 (Drug)
Participants receiving matching placebo plus standard of care
Placebo Comparator
干预措施: Placebo (Drug)
Participants receiving matching placebo plus standard of care
Placebo Comparator
干预措施: Standard of care (Drug)
结局指标
主要结局
Annualized rate of moderate or severe COPD Exacerbations
时间窗: Up to Week 78
Moderate exacerbations are defined as clinically significant exacerbations that require treatment with oral/systemic corticosteroids and/or antibiotics. Severe exacerbations are defined as clinically significant exacerbations that require in-patient hospitalization (that is greater than or equal to \[\>=\] 24 hours) or result in death.
次要结局
- Change from Baseline in St. George's respiratory questionnaire (SGRQ) total score(Baseline (Day 1) and up to Week 52)
- Change from Baseline in pre-Bronchodilator Forced expiratory volume in 1 second (FEV1)(Baseline (Day 1) and at Week 52)
- Annualized rate of COPD exacerbations requiring emergency department (ED) visit or hospitalization(Up to Week 78)
- Annualized rate of moderate/severe COPD exacerbations among participants with elevated screening blood eosinophil counts (BEC)(Up to Week 78)
- Time to first moderate or severe COPD exacerbation(Up to Week 78)
研究者
研究点 (4)
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