CTRI/2025/11/098057尚未招募2 期
A Phase 2b Randomized, Double blind, Placebo controlled, Parallel Group Study to Assess Efficacy and Safety of Verekitug UPB-101 in Participants With Moderate to Severe Chronic Obstructive Pulmonary Disease COPD
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 666
- 试验地点
- 14
- 主要终点
- Annualized rate of moderate or severe COPD exacerbation events
研究概览
简要总结
This is a global, multicenter study to assess the efficacy, safety, and tolerability of verekitug in participants with moderate-to-severe COPD. Adult participants are planned to be enrolled and will be allocated randomly in a 1:1:1 ratio to one of two dose levels of verekitug or placebo, in addition to their COPD background medications. The study consists of a screening period of approximately 4 weeks; treatment periods of between 60 weeks and up to 108 weeks; and a follow-up period, with the end-of-study visit 16 weeks after last dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Age greater than or equal to 40 to less than or equal to 85 years at the time of signing the informed consent.
- •Physician diagnosis of COPD for greater than 12 months.
- •Current or former smokers with a smoking history of 10 pack years or more.
- •Post-bronchodilator FEV1 Forced Vital Capacity FVC ratio less than 0.70 and predicted post bronchodilator FEV1 greater than 30 percent and less than or equal to 80 percent.
- •Modified Medical Research Council dyspnea scale Grade greater or equal to
- •Background triple therapy Inhaled Corticosteroid ICS, Long-Acting Beta Agonist LABA, Long-Acting Muscarinic Antagonist LAMA for 3 months before randomization with a stable dose of medications for 1 or more months prior to Visit
- •Are greater than or equal to 80 percent compliant with background therapy during the screening period.
排除标准
- •Moderate or severe exacerbation of COPD within 4 weeks prior to or during the screening period.
- •Respiratory tract infection within 4 weeks prior to or during the screening period.
- •Treatment with oxygen of greater than 4 liters per minute.
- •Nocturnal oxygen use for sleep apnea is allowed.
- •Systemic or biologic immunosuppressant therapy to treat inflammatory disease or autoimmune disease within 24 weeks or 5 half-lives prior to Visit 1, whichever is longer, with the exception of oral corticosteroids.
- •Treatment with cyclophosphamide and rituximab within 12 months of Visit
- •Current diagnosis of asthma according to the 2023 Global Initiative for Asthma guidelines or other accepted guidelines
- •History or evidence of a clinically meaningful pulmonary condition other than COPD e.g., pulmonary fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
- •Chronic hypercapnia requiring Bilevel Positive Airway Pressure BiPAP.
- •Participants requiring BiPAP periodically for an acute COPD exacerbation are not excluded.
- •Any of the following in the previous 6 months prior to Visit 1: acute myocardial infarction, transient ischemic attack or stroke, hospitalization for any cardiovascular or cerebrovascular event, pulmonary embolism, deep vein thrombosis and cardiac arrhythmia including paroxysmal e.g. intermittent.
- •Participants with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy i.e. selective beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy and stable appropriate level of anticoagulation for at least 6 months may be considered for inclusion.
结局指标
主要结局
Annualized rate of moderate or severe COPD exacerbation events
时间窗: From Day 1 (Baseline) up to Week 108
次要结局
- Change in pre-bronchodilator forced expiratory capacity in 1 second (FEV1)(From Day 1 (Baseline) to Week 60)
- Annualized rate of severe COPD exacerbation events(From Day 1 (Baseline) up to Week 108)
- Change in St Georges Respiratory Questionnaire (SGRQ) total score(From Day 1 (Baseline) to Week 60)
- Proportion of participants with SGRQ improvement of greater than 4 points(At Week 60)
- Incidence of treatment emergent adverse events and serious adverse events(From Day 1 (Baseline) up to Week 112)
研究者
Dr Annappa Kamath
Parexel International Clinical Research Private Limited
研究点 (14)
Loading locations...
相似试验
已完成
3 期
Open-label Extension of Vericiguat in Pediatric Participants with Heart Failure due to Left Ventricular Systolic Dysfunction2023-506210-40-00Merck Sharp & Dohme LLC99
招募中
2 期
A Long-Term Safety and Efficacy Study of Verekitug (UPB-101) in Adult Participants with Severe Asthma2024-519469-23-00Upstream Bio Inc.123
招募中
2 期
A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell CarcinomaNCT07381075West China Hospital90
招募中
2 期
A Study to Investigate the Efficacy and Safety of Verekitug (UPB-101) in Adult Participants with Severe Asthma (VALIANT)2023-507410-27-00Upstream Bio Inc.137
已完成
3 期
A Study of Vericiguat (MK-1242) in Participants With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)2022-500881-80-00Merck Sharp & Dohme LLC2,214