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A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization (BREEZE)

2026年8月18日 更新者：AstraZeneca

A Phase II Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

This Phase II study aims to assess the efficacy, safety, and PK of AZD0292 administered IV, as compared to placebo in participants 18 years of age and older.

The population of this study will be Chinese NCFBE patients with frequent pulmonary exacerbations due to chronic PsA airway colonization. These PsA associated pulmonary exacerbations contribute to a decline in lung function, impair quality of life and increase mortality, highlighting the urgent need for effective therapeutic options.

研究类型

介入性

注册 (估计的)

84

阶段

  • 阶段2

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

学习地点

  • 中国
      • Anyang、中国、455099
        • 招聘中
        • Research Site
      • Beijing、中国、100020
        • 招聘中
        • Research Site
      • Beijing、中国、100034
        • 招聘中
        • Research Site
      • Beijing、中国、100730
        • 尚未招聘
        • Research Site
      • Changsha、中国、410005
        • 尚未招聘
        • Research Site
      • Chengdu、中国、610014
        • 招聘中
        • Research Site
      • Chengdu、中国、611130
        • 招聘中
        • Research Site
      • Chengdu、中国、610078
        • 招聘中
        • Research Site
      • Chizhou、中国、247099
        • 招聘中
        • Research Site
      • Haikou、中国、570311
        • 招聘中
        • Research Site
      • Hefei、中国、230061
        • 招聘中
        • Research Site
      • Hohhot、中国、010010
        • 尚未招聘
        • Research Site
      • Hohhot、中国、010050
        • 招聘中
        • Research Site
      • Jinan、中国、250013
        • 招聘中
        • Research Site
      • Jinhua、中国、321000
        • 招聘中
        • Research Site
      • Jining、中国、272006
        • 尚未招聘
        • Research Site
      • Kunming、中国、650032
        • 招聘中
        • Research Site
      • Langfang、中国、065000
        • 招聘中
        • Research Site
      • Linhai、中国、317000
        • 招聘中
        • Research Site
      • Liuzhou、中国、545006
        • 招聘中
        • Research Site
      • Nanchang、中国、330006
        • 招聘中
        • Research Site
      • Nanchang、中国、330000
        • 招聘中
        • Research Site
      • Nanning、中国、530021
        • 招聘中
        • Research Site
      • Shanghai、中国、200032
        • 招聘中
        • Research Site
      • Shanghai、中国、201199
        • 招聘中
        • Research Site
      • Shanghai、中国、200065
        • 招聘中
        • Research Site
      • Shanghai、中国、200080
        • 尚未招聘
        • Research Site
      • Shanghai、中国、200240
        • 招聘中
        • Research Site
      • Shenyang、中国、110004
        • 尚未招聘
        • Research Site
      • Taicang、中国、215400
        • 招聘中
        • Research Site
      • Taizhou、中国、318000
        • 招聘中
        • Research Site
      • Wenzhou、中国、325000
        • 招聘中
        • Research Site
      • Xinxiang、中国、453100
        • 招聘中
        • Research Site
      • Xuzhou、中国、221000
        • 招聘中
        • Research Site
      • Zaozhuang、中国、277102
        • 招聘中
        • Research Site
      • Zhangzhou、中国、363099
        • 招聘中
        • Research Site
      • Zhengzhou、中国、450000
        • 尚未招聘
        • Research Site
      • Zhengzhou、中国、450006
        • 招聘中
        • Research Site
      • Zhuzhou、中国、412007
        • 招聘中
        • Research Site
      • Zibo、中国、255036
        • 招聘中
        • Research Site

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

Inclusion Criteria:

  • Participant must be ≥ 18 years of age at the time of signing the informed consent/assent.
  • Weight ≥ 35 kg.
  • Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.
  • Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics
  • Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization
  • Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.
  • Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening
  • Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.
  • Capable of giving signed informed consent/assent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria:

  • Primary lung diagnosis other than bronchiectasis
  • Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy
  • Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment
  • Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed
  • Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment
  • AIDS or Advanced human immunodeficiency virus disease (CD4 count of < 200 cells/mm3)
  • History of severe adverse reaction associated with a mAb, and/or history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine/adrenaline or hospitalization), and/or history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration
  • Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening
  • Chronic immunosuppressive therapy (including prednisolone > 5 mg or equivalent) newly initiated within the last 3 months
  • Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study
  • Participation with a study intervention used within the last 30 days or 5 half-lives of the investigational product from the other clinical study, whichever is longer, prior to screening.
  • Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration

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：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
安慰剂从第1天开始管理，随后的评估时间表随后管理。
其他：安慰剂
安慰剂从第一天通过IV输注开始管理，随后的每个评估时间表。
实验性的：AZD0292
AZD0292 administered starting on Day 1, subsequent administrations per schedule of assessments.
药品：AZD0292
AZD0292 administered starting on Day 1 via IV infusion, subsequent administrations per schedule of assessments.

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
Annualized rate of exacerbations over a variable follow-up time
大体时间：Min 28 weeks, max 52 weeks
To evaluate the effect of IV AZD0292 compared to placebo on the rate of moderate-to severe pulmonary exacerbations in participants with NCFBE and chronic colonization with PsA
Min 28 weeks, max 52 weeks

次要结果测量

结果测量
措施说明
大体时间
在可变随访时间内的严重加重的年度率
大体时间：最小28周，最大52周
评估AZD0292的影响与安慰剂对NCFBE和PSA的慢性定殖的严重加重相比
最小28周，最大52周
ADA和ADA滴度的发病率是AZD0292
大体时间：在第0周至最后剂量之间的指定时间点+12周之间
评估具有支气管扩张的参与者和PSA慢性定殖的参与者中静脉剂量的AZD0292的免疫原性
在第0周至最后剂量之间的指定时间点+12周之间
AES，SAE，AESIS和MAAES的发病率
大体时间：AES的发生；上次研究干预给药后12周的首次剂量。 SAE，AESIS和MAAES的发生；通过研究完成（最终剂量+24周）
与安慰剂相比，在接受支气管扩张的参与者和PSA慢性定殖的参与者中，AZD0292的安全性
AES的发生；上次研究干预给药后12周的首次剂量。 SAE，AESIS和MAAES的发生；通过研究完成（最终剂量+24周）
Change from baseline in QoL-B-RSS
大体时间：Over the observation period (Week 0 to Last Dose+4 weeks)
To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by QoL-B-RSS over the observation period
Over the observation period (Week 0 to Last Dose+4 weeks)
Change from baseline in SGRQ score
大体时间：Over the observation period (Week 0 to Last Dose+4 weeks)
To evaluate the effect of AZD0292 compared to placebo on quality of life, as assessed by SGRQ over the observation period.
Over the observation period (Week 0 to Last Dose+4 weeks)
Time to first moderate or severe exacerbation
大体时间：Time Frame: Through study completion (Final Dose +24 weeks)
To evaluate the effect of AZD0292 compared to placebo on time to first pulmonary exacerbation in participants with NCFBE and chronic colonization with PsA.
Time Frame: Through study completion (Final Dose +24 weeks)
Serum PK Concentrations
大体时间：At specified timepoints between Week 0 and Final Dose +12 weeks
To evaluate the PK of IV doses of AZD0292 in participants with bronchiectasis and chronic colonization with PsA
At specified timepoints between Week 0 and Final Dose +12 weeks

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。

赞助

AstraZeneca

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 (实际的)

2026年6月24日

初级完成 (估计的)

2028年1月18日

研究完成 (估计的)

2028年6月6日

研究注册日期

首次提交

2026年6月24日

首先提交符合 QC 标准的

2026年8月18日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月18日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • D7700C00010

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

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD 共享时间框架

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD 共享访问标准

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

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.

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