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A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis (ATMOS)

2026年11月5日 更新者:UCB Biopharma SRL

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis (ATMOS)

The purpose of the study is to investigate the efficacy of galvokimig versus placebo on the time to the first pulmonary exacerbation in study participants with non-cystic fibrosis bronchiectasis (NCFB)

研究概览

研究类型

介入性

注册 (估计的)

300

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

  • 姓名:UCB Cares
  • 电话号码:1-844-599-2273 (USA)
  • 邮箱:ucbcares@ucb.com

研究联系人备份

学习地点

    • California
      • Newport Beach、California、美国、92663
        • 招聘中
        • Ncfb01 50012
    • Florida
      • Brandon、Florida、美国、33511
        • 招聘中
        • Ncfb01 50003
      • Plantation、Florida、美国、33324-7006
        • 招聘中
        • Ncfb01 50005
    • Pennsylvania
      • DuBois、Pennsylvania、美国、15801
        • 招聘中
        • Ncfb01 50004
    • South Carolina
      • Rock Hill、South Carolina、美国、29732
        • 招聘中
        • Ncfb01 50007
    • Texas
      • McKinney、Texas、美国、75069
        • 招聘中
        • Ncfb01 50001
      • Mesquite、Texas、美国、75149
        • 招聘中
        • Ncfb01 50010

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

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participant must be 18 to ≤80 years of age, inclusive, at the time of signing the informed consent form (ICF)

  • Participant with a documented history of Non-Cystic Fibrosis Bronchiectasis (NCFB) (cough, chronic sputum production, and/or recurrent respiratory infections) confirmed by high resolution computed tomography (HRCT) demonstrating bronchiectasis in 1 or more lobes. Confirmation of diagnosis via HRCT will be performed as close as possible to, and within 7 calendar days of the Baseline visit, in all participants who meet all inclusion criteria and no exclusion criteria at Screening. Central reading confirmation, where images are evaluated by independent centralized experts, is required before the participant is randomized

  • Participant with a history of chronic expectoration who are current sputum producers and are able to provide spontaneous sputum sample at Screening. If the participant is unable to produce spontaneous sputum at Screening, the participant will be considered a screening failure and may be rescreened once

  • Participant with a history of at least 2 moderate or severe pulmonary exacerbations within the past 12 months prior to Screening or 1 severe pulmonary exacerbation within 6 months prior to Screening

  • Participant with post- Bronchodilator (BD) forced expiratory volume (FEV) 1% predicted ≥30% at Screening and Baseline

  • Participant has acceptable inhaler (where applicable) and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit. Participants who do not meet such criteria can be repeated once without being rescreened

  • Participant can be male or female

  • A male participant must agree to use contraception during the Intervention Period and for at least 60 days after the final dose of study intervention, and refrain from donating sperm during this period

  • A female participant is eligible to[ participate if she is not pregnant, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies:

    • Not a woman of childbearing potential (WOCBP) OR
    • A WOCBP who agrees to follow the contraceptive guidance during the Intervention Period and for at least 60 days after the final dose of study intervention

Exclusion Criteria:

  • Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or Electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study

  • Participant has a presence or family history (first degree) of inflammatory bowel disease (IBD) (includes Crohn's disease and ulcerative colitis)

  • Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within 6 months prior to the Baseline, as judged by the investigator.

  • Participant is not permitted to enroll into the study if they meet any of the following Tuberculosis (TB) exclusion criteria:

    • Known active TB disease.
    • History of active TB involving any organ system unless adequately treated according to World Health Organization/Centers for Disease Control and Prevention therapeutic guidance and proven to be fully recovered upon consultation with an appropriate relevant specialist
    • Latent tuberculosis infection (LTBI) (unless a course of appropriate preventative therapy has been completed prior to study intervention dosing). TB preventive therapy should be in accordance with applicable clinical guidelines and appropriate specialist judgment based on the origin of the infection
    • High risk of acquiring TB infection
  • Participant has clinically important pulmonary disease other than NCFB as judged by the investigator.

  • Participant has an acute infection (including pulmonary infection) requiring antibiotics, systemic corticosteroids, or antiviral medication within 4 weeks prior to Screening (and in the Screening Period) based on the final day of antibiotic/antiviral/systemic steroid treatment or hospitalization discharge date, whichever occurred later. A participant who suffers from a pulmonary exacerbation during the Screening Period, prior to randomization, is considered a screen failure. Rescreening is allowed once following resolution of the pulmonary exacerbation

  • Participant has bronchiectasis known to be due to lung fibrosis, cystic fibrosis, hypogammaglobulinemia, common variable immunodeficiency disorders or α1-antitrypsin deficiency

  • Participant has a primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma. A secondary diagnosis is allowed

  • Participant has significant hemoptysis defined as ≥300mL or requiring blood transfusion within 6 weeks from Screening

  • Participant has a history of lung transplantation

  • Study participant has an absolute neutrophil count (ANC) <1.5×10^3/μL. This test can be repeated once

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:Placebo Arm

Participants randomly assigned to this arm will receive a matching Placebo.

Drug: Placebo Pharmaceutical form: Solution for injection

实验性的:Galvokimig Dose 1 Arm

Participants randomly assigned to this arm will receive Galvokimig Dose 1

Drug: Galvokimig Pharmaceutical form: Solution for injection

其他名称:
  • UCB9741
实验性的:Galvokimig Dose 2 Arm

Participants randomly assigned to this arm will receive Galvokimig Dose 2

Drug: Galvokimig Pharmaceutical form: Solution for injection

其他名称:
  • UCB9741
实验性的:Galvokimig Dose 3 Arm

Participants randomly assigned to this arm will receive Galvokimig Dose 3

Drug: Galvokimig Pharmaceutical form: Solution for injection

其他名称:
  • UCB9741

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 from intervention assignment to first moderate or severe pulmonary exacerbation
大体时间:Up to Week 52

A moderate pulmonary exacerbation in this study is defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe oral antibiotics (with or without oral corticosteroids): Increased cough, Increased, sputum volume or change in sputum consistency, Increased sputum purulence, Increased breathlessness and/or decreased exercise tolerance, Fatigue and/or malaise, Hemoptysis. A severe pulmonary exacerbation in this study is defined as an exacerbation requiring iv antibiotics and/or hospitalization.

Up to Week 52

次要结果测量

结果测量
措施说明
大体时间
Incidence of Treatment-Emergent (TE) Adverse Events (AE)
大体时间:Up to Week 60

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A TEAE is defined as any AE with a start on or after the first administration of study intervention.

Up to Week 60
Incidence of TE Serious Adverse Events (SAEs)
大体时间:Up to Week 60

An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:

Results in death Is life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.

Up to Week 60
Annualized rate of pulmonary exacerbations
大体时间:Up to Week 52

A moderate pulmonary exacerbation in this study is defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe oral antibiotics (with or without oral corticosteroids): Increased cough, Increased, sputum volume or change in sputum consistency, Increased sputum purulence, Increased breathlessness and/or decreased exercise tolerance, Fatigue and/or malaise, Hemoptysis. A severe pulmonary exacerbation in this study is defined as an exacerbation requiring iv antibiotics and/or hospitalization.

Up to Week 52
Post bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 24
大体时间:At Week 24

Lung function will be measured by centrally provided spirometry equipment. Spirometry at clinical site visits should be performed in accordance with the American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Post-BD spirometry should be performed consistent with the mechanism of action of reliever (ie, 30 minutes [±5 minutes] following 4 puffs of 100μg/puff of salbutamol or albuterol). Three measurements fulfilling the ATS/ERS acceptability and repeatability criteria should be obtained at every spirometry visit.

At Week 24
Change from Baseline in Quality of life questionnaire-bronchiectasis (QOL-B) Respiratory Symptoms Domain Scores at Week 24
大体时间:At Week 24

The QOL-B is a disease-specific, PRO designed to assess symptoms, functioning, and health related quality of life in adults with bronchiectasis. It comprises 37 items grouped into 8 domains. Items use 4-point Likert-type response options, with recall periods typically referencing the previous week. Each domain is scored separately and standardized to a 0-100 scale, where higher scores indicate better health status; no total score is calculated.

At Week 24

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。

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8月5日

初级完成 (估计的)

2029年2月28日

研究完成 (估计的)

2029年4月26日

研究注册日期

首次提交

2026年7月17日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • NCFB01
  • 2026-525524-18-00 (克蒂斯)
  • U1111-1337-0405 (其他标识符:Universal Trial Number (UTN))

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

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

IPD 共享时间框架

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.

IPD 共享访问标准

Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 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.

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