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
- 进行中（未招募）
- 入组人数
- 666
- 试验地点
- 246
- 主要终点
- Annualized rate of moderate or severe COPD exacerbation events
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of verekitug (UPB-101) in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), an inflammatory lung disease.
详细描述
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
- 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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of COPD for >12 months.
- •Current or former smokers with a smoking history of 10 pack-years or more.
- •Post-bronchodilator FEV1/ Forced Vital Capacity (FVC) ratio <0.70 and predicted post-bronchodilator FEV1 >30% and ≤80%.
- •Modified Medical Research Council dyspnea scale Grade ≥
- •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 ≥80% 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 >4 liters/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 arrhythmias 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.
研究组 & 干预措施
Placebo
Participants will receive 0.5 mL of matching placebo and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.
干预措施: Placebo (Other)
Verekitug (UPB-101) 100 mg and Placebo
Participants will receive 0.5 milliliter (mL) of the formulated solution (containing 100 milligrams [mg] of verekitug [UPB-101]) and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.
干预措施: Verekitug (Drug)
Verekitug (UPB-101) 100 mg and Placebo
Participants will receive 0.5 milliliter (mL) of the formulated solution (containing 100 milligrams [mg] of verekitug [UPB-101]) and 2.0 mL of matching placebo subcutaneously in two separate injections every 12 weeks up to Week 96.
干预措施: Placebo (Other)
Verekitug (UPB-101) 400 mg and Placebo
Participants will receive 2.0 mL of the formulated solution (containing 400 mg of verekitug [UPB-101]) and 0.5 mL of matching placebo subcutaneously in two separate injections every 24 weeks up to Week 96. Participants will also receive 2.0 mL and 0.5 mL of matching placebo subcutaneously in two separate injections at Weeks 12, 36, 60 and 84 visits.
干预措施: Placebo (Other)
Verekitug (UPB-101) 400 mg and Placebo
Participants will receive 2.0 mL of the formulated solution (containing 400 mg of verekitug [UPB-101]) and 0.5 mL of matching placebo subcutaneously in two separate injections every 24 weeks up to Week 96. Participants will also receive 2.0 mL and 0.5 mL of matching placebo subcutaneously in two separate injections at Weeks 12, 36, 60 and 84 visits.
干预措施: Verekitug (Drug)
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
- Proportion of participants with SGRQ improvement of >4 points(At Week 60)
- 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)
- Incidence of treatment-emergent adverse events and serious adverse events(From Day 1 (Baseline) up to Week 112)
- Change in St. George's Respiratory Questionnaire (SGRQ) total score(From Day 1 (Baseline) to Week 60)