中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600126449
最近更新日期： Date of Last Refreshed on：	2026-06-09 14:34:25
注册时间： Date of Registration：	2026-06-09 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	一项研究者发起的评价伏欣奇拜单抗皮下注射给药用于治疗成人特发性肺纤维化急性加重（AE-IPF）受试者的安全性和有效性的前瞻性、单中心、单臂、历史对照研究
Public title：	A prospective, single-center, single-arm, historically controlled study initiated by investigators to evaluate the safety and efficacy of subcutaneous injection of Vuxinqibaimab in the treatment of adult subjects with acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF).
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项研究者发起的评价伏欣奇拜单抗皮下注射给药用于治疗成人特发性肺纤维化急性加重（AE-IPF）受试者的安全性和有效性的前瞻性、单中心、单臂、历史对照研究
Scientific title：	A prospective, single-center, single-arm, historically controlled study initiated by investigators to evaluate the safety and efficacy of subcutaneous injection of Vuxinqibaimab in the treatment of adult subjects with acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF).
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	庄冯辉	研究负责人：	陈昶
Applicant：	Fenghui Zhuang	Study leader：	Chang Chen
申请注册联系人电话： Applicant telephone：	+86 19121912521	研究负责人电话： Study leader's telephone：	+86 21 65115006
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	zhuangfh1999@foxmail.com	研究负责人电子邮件： Study leader's E-mail：	changchenc@tongji.edu.cn
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	上海市杨浦区政民路507号	研究负责人通讯地址：	上海市杨浦区政民路507号
Applicant address：	No. 507 Zhengmin Road, Yangpu District, Shanghai	Study leader's address：	No. 507 Zhengmin Road, Yangpu District, Shanghai
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	同济大学附属上海市肺科医院
Applicant's institution：	Shanghai Pulmonary Hospital Affiliated to Tongji University
研究负责人所在单位：	上海市肺科医院
Affiliation of the Leader：	Shanghai Pulmonary Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	L26-514	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	上海市肺科医院医学伦理委员会
Name of the ethic committee：	Instituional Review Board Shanghai Pulmonary Hospital Tongji University
伦理委员会批准日期： Date of approved by ethic committee：	2026-04-23 00:00:00
伦理委员会联系人：	桂涛
Contact Name of the ethic committee：	Gui Tao
伦理委员会联系地址：	上海市杨浦区政民路507号
Contact Address of the ethic committee：	No. 507 Zhengmin Road, Yangpu District, Shanghai
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 65115006	伦理委员会联系人邮箱： Contact email of the ethic committee：	fkyygcp@163.com

研究实施负责（组长）单位：

上海市肺科医院

Primary sponsor：

Shanghai Pulmonary Hospital

研究实施负责（组长）单位地址：

上海市杨浦区政民路507号

Primary sponsor's address：

No. 507 Zhengmin Road, Yangpu District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市肺科医院	具体地址：	上海市杨浦区政民路507号
Institution hospital：	Shanghai Pulmonary Hospital	Address：	No. 507 Zhengmin Road, Yangpu District, Shanghai

经费或物资来源：

广州市东方感染与炎症研究院

Source(s) of funding：

Guangzhou Oriental Infection and Inflammation Research Institute

研究疾病：

特发性肺纤维化急性加重

Target disease：

Acute exacerbation of idiopathic pulmonary fibrosis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

主要研究目的评价成人AE-IPF受试者接受伏欣奇拜单抗皮下注射90天的有效性次要研究目的评价成人AE-IPF受试者接受伏欣奇拜单抗皮下注射90天的安全性评价成人AE-IPF受试者接受伏欣奇拜单抗皮下注射90天实验室检查指标相对基线的变化探索性目的评价成人AE-IPF受试者接受伏欣奇拜单抗皮下注射90天激素减量成功的受试者比例

Objectives of Study：

Primary Research Objective To evaluate the efficacy of subcutaneous administration of Fuxinqibai in adult AE-IPF subjects over 90 days. Secondary Research Objectives To evaluate the safety of subcutaneous administration of Fuxinqibai in adult AE-IPF subjects over 90 days. To evaluate the changes in laboratory test parameters relative to baseline in adult AE-IPF subjects receiving subcutaneous administration of Fuxinqibai over 90 days. Exploratory Objective To evaluate the proportion of adult AE-IPF subjects successfully tapering steroids over 90 days while receiving subcutaneous administration of Fuxinqibai.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1.Age >= 40 years;
2.Based on the comprehensive judgment of the researchers, the past medical history conforms to the clinical diagnosis and treatment standards outlined in the 2022 ATS/ERS/JRS/ALAT guidelines, thus the diagnosis of idiopathic pulmonary fibrosis (IPF) can be confirmed;
3.Subjects diagnosed with acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) by researchers, who have experienced worsening or new onset of dyspnea or hypoxemia within the last 30 days, and meet all of the following criteria (1) to (3) during the course of the disease: (1) Unexplained sudden onset or worsening of dyspnea within 1 month (or 30 days); (2) Chest high-resolution computed tomography (HRCT) with local review showing ground-glass opacity and/or consolidation on the basis of a reticular or honeycombing usual interstitial pneumonia (UIP) pattern; (3) No significant pneumothorax, malignancy, pulmonary embolism, or left heart failure;
4.Possess the ability to provide informed consent and are willing to adhere to the research requirements;

排除标准：

1.根据临床评估，存在导致呼吸功能不全的其他或替代性病因，包括充血性心力衰竭、严重感染、血栓栓塞等； 2.因胸外科手术（包括胸腔镜肺活检）而急性恶化； 3.通过气管内插管接受机械通气； 4.过去6个月内已知出现过急性加重的IPF患者（以病历记录为准）； 5.排除人免疫缺陷病毒（HIV）阳性或乙型肝炎表面抗原（HBsAg）阳性或HCV抗体（HCVAb）阳性或特异性密螺旋体抗体阳性或梅毒感染的受试者 (1). HBV阳性定义为HBsAg阳性或HBcAb阳性 + HBV DNA阳性。允许HBcAb阳性 + HBV DNA阴性入组。(2).HCV阳性定义为 HCV 抗体阳性 + HCV RNA 阳性。允许HCV抗体阳性 + HCV RNA阴性入组。(3).HIV阳性定义为HIV抗体阳性。 6.排除结核感染患者，包括结核（TB）或隐匿性结核感染（符合下列条件之一）： (1) 筛选时存在活动性TB或有活动性TB症状； (2) 体格检查提示活动性TB； (3) 筛选前4周内或筛选时γ-干扰素释放试验阳性； (4) 筛选前3个月内影像学检查提示存在活动性TB征象； 7.存在高渗状态或糖尿病酮症酸中毒提示糖尿病未受控制，或存在未控制的高血压（收缩压 >160 mmHg 且舒张压 >100 mmHg），这些情况会禁忌使用皮质类固醇。 8.凝血功能障碍，定义为国际标准化比值（INR）>1.6、部分凝血活酶时间（PTT）> 对照值的2倍、纤维蛋白原 <100 mg/dL、或血小板计数 <50K/μL，除非这些异常能够被安全地纠正。 9.活动性恶性肿瘤或正在接受恶性肿瘤治疗（不包括基底细胞癌或鳞状细胞皮肤癌以及低风险前列腺癌。低风险前列腺癌定义为T1或T2a期，且前列腺特异性抗原（PSA）低于10 ng/dl）。实验性治疗已知不会促进癌症进展，且这些标准符合现行指南。 10.既往使用过以下任何一种药物治疗： (1) 抗纤维化药物：已使用了抗纤维化背景治疗（吡非尼酮和尼达尼布，以下简称SOC）的患者，允许在试验过程中继续使用SOC，试验期间尽量不做剂量调整；入组前未使用SOC的患者，需在知情同意时承诺研究过程当中不使用SOC。 (2) 入组前曾经接受过IL-1β单抗或其他同靶点药物的治疗（包括但不限于阿那白滞素、卡纳单抗、利纳西普等）； 11.有生育能力的女性不同意采取避孕或禁欲，或妊娠试验（尿液或血液）呈阳性。特发性肺纤维化（IPF）是一种好发于老年人且以男性为主的疾病，因此此情况不常见。 12.同时参与其他干预性临床研究。若受试者既往参加过其他干预性临床研究，需在之前临床研究完成结束后才可考虑参与本研究。 13.在入组时已登记在册等待肺移植的受试者。 (1) 在筛选期，已正式列入官方肺移植等待名单，且预计在未来90天内可能获得供肺并进行移植手术的受试者。 (2) 对于入组后才开始评估或列入肺移植等待名单的受试者，不因此原因而退出研究。但其数据将按预设方案进行特殊处理（可以在统计分析计划[SAP]中进行更详细的规定）。一旦接受肺移植，该时间点即被记录为竞争风险事件，并作为研究观察的终点。接受肺移植的结局可以考虑等同于“治疗失败”或者“死亡事件”，在SAP中做相应处理规定。 14.存在对试验用药品或对类似结构分子的过敏反应史；不能进行皮下或静脉注射者，例如正在接受抗凝血药治疗、血小板减少、已知患有出血性疾病或存在特发性血小板减少性紫癜； 15.存在严重合并症或其他情况，研究者认为应排除受试者或预计会干扰研究参与。

Exclusion criteria：

1.Based on clinical evaluation, there are other or alternative causes leading to respiratory insufficiency, including congestive heart failure, severe infection, thromboembolism, etc; 2.Acute deterioration due to thoracic surgery (including thoracoscopic lung biopsy); 3.Receive mechanical ventilation through endotracheal intubation; 4.IPF patients who have known acute exacerbation in the past 6 months (subject to medical records); 5.Subjects who are HIV-positive, HBsAg-positive, HCVAb-positive, specific treponema antibody-positive, or have syphilis infection are excluded. (1) HBV-positive is defined as HBsAg-positive or HBcAb-positive + HBV DNA-positive. Subjects with HBcAb-positive + HBV DNA-negative are also allowed to be included. (2) HCV-positive is defined as HCV antibody-positive + HCV RNA-positive. Subjects with HCV antibody-positive + HCV RNA-negative are also allowed to be included. (3) HIV-positive is defined as HIV antibody-positive. 6.Excluding patients with tuberculosis infection, including tuberculosis (TB) or latent tuberculosis infection (meeting one of the following criteria): (1) active TB or symptoms of active TB at screening; (2) active TB indicated by physical examination; (3) positive gamma interferon release test within 4 weeks before or at screening; (4) active TB signs indicated by imaging examination within 3 months before screening; 7.The presence of hyperosmolarity or diabetic ketoacidosis indicates uncontrolled diabetes, or the presence of uncontrolled hypertension (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg), which are contraindications to the use of corticosteroids; 8.Coagulopathy is defined as an international normalized ratio (INR) >1.6, a partial thromboplastin time (PTT) >2 times the control value, a fibrinogen level <100 mg/dL, or a platelet count <50K/μL, unless these abnormalities can be safely corrected; 9.Active malignancy or undergoing treatment for malignancy (excluding basal cell carcinoma or squamous cell skin cancer, as well as low-risk prostate cancer. Low-risk prostate cancer is defined as T1 or T2a stage, with prostate-specific antigen (PSA) less than 10 ng/dl). Experimental treatments are known not to promote cancer progression, and these criteria are in accordance with current guidelines; 10.Previous treatment with any of the following medications: (1) Antifibrotic drugs: Patients who have received background treatment with antifibrotic drugs (pirfenidone and nintedanib, hereinafter referred to as SOC) are allowed to continue using SOC during the trial, with minimal dosage adjustments; patients who have not used SOC before enrollment must promise not to use SOC during the study process when providing informed consent. (2) Previous treatment with IL-1β monoclonal antibody or other drugs targeting the same target (including but not limited to anakinra, canakinumab, linaclotide, etc.) before enrollment; 11.Females who are capable of bearing children do not agree to contraception or abstinence, or test positive for pregnancy (urine or blood). Idiopathic pulmonary fibrosis (IPF) is a disease that primarily affects older adults and is more common in males, so this situation is rare; 12.Participate in other interventional clinical studies at the same time. If the subject has previously participated in other interventional clinical studies, they must wait until the completion of those previous studies before being considered for participation in this study; 13.Subjects who have been registered and are waiting for lung transplantation at the time of enrollment. (1) During the screening period, subjects who have been officially included in the official lung transplantation waiting list and are expected to receive a donor lung and undergo transplantation surgery within the next 90 days. (2) For subjects who are evaluated or included in the lung transplantation waiting list after enrollment, they will not be excluded from the study for this reason. However, their data will be specially processed according to the preset protocol (more detailed provisions can be made in the Statistical Analysis Plan [SAP]). Once a lung transplantation is received, this time point will be recorded as a competing risk event and serve as the endpoint of the study observation. The outcome of receiving a lung transplantation can be considered equivalent to "treatment failure" or "death event", and corresponding processing provisions will be made in the SAP; 14.Individuals with a history of allergic reactions to investigational drugs or structurally similar molecules; those who cannot undergo subcutaneous or intravenous injections, such as those undergoing anticoagulant therapy, those with thrombocytopenia, known bleeding disorders, or those with idiopathic thrombocytopenic purpura; 15.Due to severe comorbidities or other conditions, the investigator believes that the subject should be excluded or is expected to interfere with study participation.

研究实施时间：

Study execute time：

从 From 2026-06-15 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-06-15 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	33
Group：	Experimental group	Sample size：	33
干预措施：	伏欣奇拜单抗皮下注射给药	干预措施代码：
Intervention：	Subcutaneous injection of Firsekibart	Intervention code：

组别：	哨兵组	样本量：	3
Group：	Sentry Team	Sample size：	3
干预措施：	伏欣奇拜单抗皮下注射给药	干预措施代码：
Intervention：	Subcutaneous injection of Firsekibart	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市肺科医院	单位级别：	三级甲等
Institution hospital：	Shanghai Pulmonary Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	生存率	指标类型：	主要指标
Outcome：	Survival rate	Type：	Primary indicator
测量时间点：	90天	测量方法：	统计患者90天的生存率
Measure time point of outcome：	Day 90	Measure method：	Calculate the 90-day survival rate of patients

指标中文名：	有效激素减量操作的受试者比例以及有效激素减量成功受试者的比例	指标类型：	次要指标
Outcome：	Proportion of subjects with effective hormone reduction and proportion of successful subjects with effective hormone reduction	Type：	Secondary indicator
测量时间点：	第一次给药后2周内,12周	测量方法：	计算第一次给药后2周内实施激素减量的受试者比例和12周时激素减量成功的受试者比例，分析方法为描述性统计（例数与百分比）
Measure time point of outcome：	Within 2 weeks after the first dose, 12 weeks	Measure method：	Calculate the proportion of subjects who underwent hormone reduction within 2 weeks after the first administration and the proportion of subjects who successfully underwent hormone reduction at 12 weeks using descriptive statistics (number and percentage)

指标中文名：	安全性评价指标包括：生命体征、体格检查、实验室检查、12导联心电图、不良事件（AE）等	指标类型：	次要指标
Outcome：	The safety evaluation indicators include: vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, adverse events (AE), etc	Type：	Secondary indicator
测量时间点：	基线，4周，8周，12周	测量方法：	成人AE-IPF受试者接受伏欣奇拜单抗皮下注射12周血清C反应蛋白（CRP）、红细胞沉降率（ESR）、白细胞介素6（IL-6）、血清淀粉样蛋白A（SAA）的水平相对基线的变化
Measure time point of outcome：	Baseline, 4 weeks, 8 weeks, 12 weeks	Measure method：	Changes in serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), interleukin-6 (IL-6), and serum amyloid A (SAA) levels relative to baseline in adult AE-IPF subjects receiving subcutaneous injection of Fuxinqiba monoclonal antibody for 12 weeks

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	外周血	组织：
Sample Name：	Peripheral blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	40	岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	否No
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	NO
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	申办方和指定人确认并坚持患者隐私权免受侵犯的原则。在整个研究中，患者的原始数据将仅通过唯一的识别号与申办方的临床研究数据库或文档相关联。正如所有适用的法律和法规所允许的，可以使用有限的患者信息(例如性别、年龄或出生日期)和患者姓名首字母来确认患者身份和患者唯一识别号的准确性。为了遵守 ICH GCP 指南和确认本方案的遵守情况，申办方要求研究者允许其监查员或指定的监查员、任何监管机构的代表、申办方指定的稽查员以及适当的 IRB 和 IEC 审查患者的原始医疗记录(原始数据或文件)，包括但不限于实验室检测报告、ECG 报告、在患者参与研究期间发生的入院和出院记录以及尸检报告等。作为知情同意过程的一部分，获取患者的原始医疗记录需要患者的具体授权。提供给申办方的任何患者的原始文件副本必须删除某些个人身份信息(即，患者的 eCRF 上未收集的患者姓名、地址和其他标识字段)。研究者保留的记录包括(但不限于):研究特定文件、所有受试者的身份识别日志、医疗记录、临时介质文件(热敏纸应该复印和认证)、原始数据、所有原始签名和注明日期的知情同意书、所有纸质 eCRF 副本和质疑表回复的副本(包括药物详细的处理记录，以便能够使申办方或其指定人员进行评估或监查)。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The sponsor and the designated person confirm and adhere to the principle of protecting patients' privacy from infringement. Throughout the study, the patient's raw data will be associated with the sponsor's clinical research database or documentation solely through a unique identification number. As permitted by all applicable laws and regulations, limited patient information (such as gender, age, or date of birth) and the patient's initials may be used to confirm the patient's identity and the accuracy of the patient's unique identification number. In order to comply with the ICH GCP guidelines and confirm adherence to this protocol, the sponsor requires the investigator to allow its monitors or designated monitors, representatives of any regulatory authorities, auditors designated by the sponsor, and appropriate IRBs and IECs to review the patients' original medical records (original data or documents), including but not limited to laboratory test reports, ECG reports, admission and discharge records occurring during the patient's participation in the study, and autopsy reports. As part of the informed consent process, obtaining the patients' original medical records requires specific authorization from the patients. Copies of original documents provided to the sponsor for any patient must have certain personally identifiable information removed (i.e., the patient's name, address, and other identifying fields not collected on the patient's eCRF).The records retained by the researchers include (but are not limited to): specific study documents, identification logs of all subjects, medical records, temporary media files (thermal paper should be copied and authenticated), raw data, all original signed and dated informed consent forms, all paper copies of eCRF and copies of responses to inquiry forms (including detailed drug handling records to enable evaluation or monitoring by the sponsor or its designated personnel).
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-06-09 14:33:57