NCT06940154已完成2 期
A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Chronic Obstructive Pulmonary Disease and Type 2 Inflammation
Connect Biopharm LLC61 个研究点 分布在 4 个国家目标入组 159 人开始时间: 2025年8月12日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 61
- 主要终点
- Treatment failure rate
研究概览
简要总结
This is a Phase 2, multicenter study in adult participants with an acute COPD exacerbation and type 2 inflammation
详细描述
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute COPD exacerbation with type 2 inflammation in the urgent healthcare setting to compare rademikibart plus standard therapy to standard therapy (plus placebo).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician-diagnosed COPD with duration of ≥12 months.
- •Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
- •Participants in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
- •Current or former smoker with a history of smoking of ≥10 pack-years.
- •Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.
- •Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation.
- •Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.
排除标准
- •Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
- •Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.
- •Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.
- •Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.
- •Transient ischemic attack or stroke <6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event <6 months from Screening Visit.
- •Known or suspected history of immunosuppression.
- •History of known immunodeficiency disorder or hepatitis B or C.
- •History of alcohol abuse and/or drug abuse.
- •Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success.
- •Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for >15 hours a day.
- •Participants on long-term macrolide.
- •Current acute COPD exacerbation for which SoC was started >48 hours prior to Screening.
- •A recent chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan).
- •Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization.
- •Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.
- •Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
- •Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.
- •Treatment with systemic corticosteroids (ie, oral or by injection) and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.
- •The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Rademikibart
Experimental
干预措施: Rademikibart in prefilled syringe (Combination Product)
Placebo
Placebo Comparator
干预措施: Matching placebo in prefilled syringe (Drug)
结局指标
主要结局
Treatment failure rate
时间窗: 28 days
Treatment failure is defined as death due to any cause, (re)admission to a hospital for COPD, ED (re)visit or unscheduled medical visit for worsening of COPD symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for COPD exacerbation) within 28 days after randomization.
次要结局
- Absolute CFB in post-BD FEV1 at Day 3, Week 1, and Week 4(Day 3, Week 1, and Week 4)
- Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported(56 days)
- Incidence of unanticipated adverse device effects (UADEs)(56 days)
- Incidence of injection site reactions(56 days)
- Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1(Week 1)
- Mean CFB in EXACT-PRO score(Week 1, Week 2, and Week 4)
- Absolute CFB in post-BD FEV1 at Day 3 and Week 4(Day 3, Week 1, and Week 4)
- Rate of new moderate and severe COPD exacerbations over the 28 days after randomization(28 days)
- Time to the first new moderate or severe COPD exacerbation in the 28 days after randomization(28 days)
- Mean change from baseline (CFB) in EXACT-PRO score(Week 1, Week 2, and Week 4)
研究者
研究点 (61)
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