This After Market Study is Seeing if Dupilumab Plus Usual Standard of Care (SOC) is Better Than Usual Care Alone for Adult Participants After a Severe Chronic Obstructive Pulmonary Disease (COPD) Flare-Up Requiring Hospitalization (MISSION)
2026年5月8日 更新者：Regeneron Pharmaceuticals
A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy of Dupilumab Added on to Standard of Care (SOC) Treatment vs SOC Treatment Following Hospitalization for a COPD Exacerbation
This study is researching a drug called dupilumab, referred to as "study drug". The study is focused on people diagnosed with COPD to determine if the study drug, in addition to standard of care treatment for COPD, might reduce the reoccurrence of a COPD exacerbation (a "flare-up") happening within the study treatment duration (around 90 days).
The study is looking at another research question:
• What side effects may happen from taking the study drug
研究概览
研究类型
介入性
注册 (估计的)
754
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Clinical Trials Administrator
- 电话号码：844-734-6643
- 邮箱：clinicaltrials@regeneron.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Key Inclusion Criteria:
- Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol
- Hospitalized or admitted to the ED >24 hours (from time of first admission or presentation to the ED) for acute exacerbation of COPD as primary diagnosis according to the principal investigator and exacerbation is managed by Systemic Corticosteroids (SCS) ± antibiotics and other appropriate treatments as per SOC
- Elevated blood eosinophil counts during the current exacerbation, as defined in the protocol. The exacerbation event starts from the day Systemic Corticosteroids (SCS) ± antibiotics are administered continuously up to the day they presented to ED/hospital
Key Exclusion Criteria:
- Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay
- Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol
- Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments
- Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments
- Cardiac-related comorbidity, as defined in the protocol
- Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol
- Any biologic therapy or biologic Investigational Medicinal Product (IMP) to treat type 2 inflammatory diseases within 6 months prior to the screening visit or 5 half-lives, whichever is longer, as defined in the protocol
NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
根据协议进行管理
|
|
实验性的：杜匹鲁单抗
|
根据协议管理
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to first all-cause event
大体时间：Through day 90
|
All-cause event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death
|
Through day 90
|
|
Number of moderate or severe COPD exacerbations
大体时间：Through day 90
|
Through day 90
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to first COPD-related event
大体时间：Through day 90
|
COPD-related event may include non-elective hospital readmission, Emergency Department (ED)/urgent care visit, or death
|
Through day 90
|
|
Time to first moderate and/or severe COPD exacerbation
大体时间：Through day 90
|
Through day 90
|
|
|
Number of all-cause non-elective hospital readmissions
大体时间：Through day 90
|
Through day 90
|
|
|
Number of ED visits
大体时间：Through day 90
|
Through day 90
|
|
|
Number of COPD-related hospital readmissions
大体时间：Through day 90
|
Through day 90
|
|
|
Number of COPD-related ED visits
大体时间：Through day 90
|
Through day 90
|
|
|
Number of all-cause deaths
大体时间：Through day 90
|
Through day 90
|
|
|
Number of COPD-related deaths
大体时间：Through day 90
|
Through day 90
|
|
|
Occurrence of all-cause non-elective hospital readmissions
大体时间：Through day 60
|
Through day 60
|
|
|
Occurrence of all-cause ED visits
大体时间：Through day 60
|
Through day 60
|
|
|
Occurrence of all-cause deaths
大体时间：Through day 60
|
Through day 60
|
|
|
Occurrence of COPD-related hospital readmissions
大体时间：Through day 60
|
Through day 60
|
|
|
Occurrence of ED visits
大体时间：Through day 60
|
Through day 60
|
|
|
Occurrence of deaths
大体时间：Through day 60
|
Through day 60
|
|
|
Change in Chronic Airways Assessment Test (CAAT) score
大体时间：From baseline through day 90
|
CAAT is a PRO measure that assesses the impact of lung disease on a person's life using an 8-item questionnaire with a 40-point scale with higher scores indicating worse disease.
|
From baseline through day 90
|
|
Change in EXAcerbation of Chronic pulmonary disease Tool (EXACT) questionnaire score
大体时间：From baseline through day 90
|
EXACT is a patient-reported daily diary that captures respiratory symptoms in COPD using a 14-item questionnaire with a 0 to 100-point scale with higher scores indicating worse disease symptoms.
|
From baseline through day 90
|
|
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
大体时间：Through day 90
|
Through day 90
|
|
|
Occurrence of Serious Adverse Events (SAEs)
大体时间：Through day 90
|
Through day 90
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 研究主任：Clinical Trial Management、Regeneron Pharmaceuticals
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月30日
初级完成 (估计的)
2028年7月30日
研究完成 (估计的)
2028年7月30日
研究注册日期
首次提交
2026年5月8日
首先提交符合 QC 标准的
2026年5月8日
首次发布 (实际的)
2026年5月14日
研究记录更新
最后更新发布 (实际的)
2026年5月14日
上次提交的符合 QC 标准的更新
2026年5月8日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- R668-COPD-2491
- 2025-524392-23-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
IPD 共享时间框架
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD 共享访问标准
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli.
Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.