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评估 GSK3915393 对特发性肺纤维化 (IPF) 参与者的疗效和安全性的研究

2026年8月20日 更新者：GlaxoSmithKline

一项 2 期、随机、双盲、安慰剂对照、平行组研究 (TRANSFORM)，旨在评估 GSK3915393 对特发性肺纤维化 (IPF) 参与者的疗效和安全性

特发性肺纤维化是一种慢性肺部疾病，会导致肺部疤痕和呼吸困难。 GSK3915393是一种新药，首次在 IPF 参与者中进行测试。 该研究将评估 GSK3915393 在 IPF 参与者中的安全性和有效性。

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

158

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。

学习地点

  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 1M9
        • GSK Investigational Site
    • Newfoundland and Labrador
      • St. John's、Newfoundland and Labrador、加拿大、A1B 3V6
        • GSK Investigational Site
    • Ontario
      • Ajax、Ontario、加拿大、L1S 2J5
        • GSK Investigational Site
      • Hamilton、Ontario、加拿大、L8N 4A6
        • GSK Investigational Site
    • Quebec
      • Trois-Rivières、Quebec、加拿大、G8T 7A1
        • GSK Investigational Site
  • 德国
      • Essen、德国、45293
        • GSK Investigational Site
      • Hanover、德国、30173
        • GSK Investigational Site
      • Heidelberg、德国、69126
        • GSK Investigational Site
      • Wuppertal、德国、42283
        • GSK Investigational Site
  • 意大利
      • Catania、意大利、95123
        • GSK Investigational Site
      • Monza MB、意大利、20900
        • GSK Investigational Site
      • Naples、意大利
        • GSK Investigational Site
      • Padova、意大利、35128
        • GSK Investigational Site
      • Perugia、意大利、06132
        • GSK Investigational Site
      • Pisa、意大利、56124
        • GSK Investigational Site
      • Roma、意大利、00168
        • GSK Investigational Site
      • Sassari、意大利、07100
        • GSK Investigational Site
      • Torrette AN、意大利
        • GSK Investigational Site
  • 法国
      • La Tronche、法国、38700
        • GSK Investigational Site
      • Paris、法国、75018
        • GSK Investigational Site
      • Pessac、法国、33604
        • GSK Investigational Site
      • Rennes、法国、35000
        • GSK Investigational Site
      • Rouen、法国、76000
        • GSK Investigational Site
      • Toulouse、法国、31059
        • GSK Investigational Site
  • 波兰
      • Bialystok、波兰、15-044
        • GSK Investigational Site
      • Lodz、波兰、90-153
        • GSK Investigational Site
      • Poznan、波兰、60-569
        • GSK Investigational Site
  • 美国
    • California
      • Newport Beach、California、美国、92663
        • GSK Investigational Site
    • Florida
      • Jacksonville、Florida、美国、32224
        • GSK Investigational Site
      • St. Petersburg、Florida、美国、33704
        • GSK Investigational Site
    • Michigan
      • Ann Arbor、Michigan、美国、48109-5360
        • GSK Investigational Site
    • Minnesota
      • Rochester、Minnesota、美国、55905
        • GSK Investigational Site
    • New York
      • New York、New York、美国、10065
        • GSK Investigational Site
    • North Carolina
      • Wilmington、North Carolina、美国、28401
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19140
        • GSK Investigational Site
    • Tennessee
      • Nashville、Tennessee、美国、37204
        • GSK Investigational Site
    • Texas
      • Cypress、Texas、美国、77429
        • GSK Investigational Site
  • 英国
      • Edinburgh、英国、EH16 4SA
        • GSK Investigational Site
      • Leeds West Yorkshire、英国、LS9 7TF
        • GSK Investigational Site
      • London、英国、SW3 6HP
        • GSK Investigational Site
  • 荷兰
      • Eindhoven、荷兰、5623 EJ
        • GSK Investigational Site
      • Rotterdam、荷兰、3015 CE
        • GSK Investigational Site
  • 西班牙
      • Barcelona、西班牙
        • GSK Investigational Site
      • Barcelona、西班牙、08907
        • GSK Investigational Site
      • Madrid、西班牙、28006
        • GSK Investigational Site
      • Madrid、西班牙、28007
        • GSK Investigational Site
      • Oviedo、西班牙、33011
        • GSK Investigational Site
      • Pozuelo de AlarcOn Madr、西班牙、28223
        • GSK Investigational Site
      • Santander、西班牙、39011
        • GSK Investigational Site
      • Seville、西班牙、41013
        • GSK Investigational Site
  • 阿根廷
      • Buenos Aires、阿根廷、C1426ABP
        • GSK Investigational Site
      • Ciudad Autonoma de Bueno、阿根廷、C1207AAP
        • GSK Investigational Site
      • Florida、阿根廷、B1602DQD
        • GSK Investigational Site
      • La Plata、阿根廷、1900
        • GSK Investigational Site
      • Mendoza、阿根廷、M5500CCG
        • GSK Investigational Site
      • Rosario、阿根廷、S2000DBS
        • GSK Investigational 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

纳入标准：

  • 根据诊断时适用的美国胸科学会 (ATS)/欧洲呼吸学会 (ERS)/日本呼吸学会 (JRS)/拉丁美洲胸科学会 (ALAT) 指南，在筛查前 5 年内诊断患有 IPF 的参与者。
  • 集中读取筛查时获得的胸部高分辨率计算机断层扫描 (HRCT) 或筛查后 12 个月内获得的历史 HRCT，与普通间质性肺炎 (UIP) 或可能的 UIP 一致（如果 HRCT 结果不确定，IPF 可以通过历史活检在当地确诊） 。
  • FVC 大于或等于 (>=) 预测正常值的 45% (%)。
  • 一氧化碳 (DLCO) 的（肺）扩散能力 >= 校正血红蛋白 (Hb) 的预测正常值的 25%。
  • 支气管扩张剂前 1 秒用力呼气量 (FEV1)/FVC ≥ 0.7。
  • 如果接受抗纤维药物治疗，则必须在筛查前至少 12 周服用稳定剂量的尼达尼布或吡非尼酮。
  • 如果当前未接受吡非尼酮或尼达尼布治疗，则参与者必须在筛选前停止服用吡非尼酮或尼达尼布至少 4 周。
  • 体重≥40公斤（kg）且体重指数在18.5-35公斤每平方米（kg/m2）（含）范围内。
  • 如果女性参与者是无生育能力的女性 (WONCBP)，则该女性参与者有资格参加
  • 能够签署知情同意书

排除标准：

  • 患有与其他已知原因相关的间质性肺病 (ILD) 的参与者。
  • 诊断结节病或任何系统性自身免疫性疾病（包括但不限于硬皮病、多发性肌炎/皮肌炎、系统性红斑狼疮和类风湿性关节炎）。
  • 筛选前 6 个月内和/或筛选期间（研究者确定）IPF 急性加重。
  • 筛查时患有临床显着的非实质性肺部疾病（例如哮喘、慢性阻塞性肺病、空洞或胸膜疾病）。
  • 严重肺动脉高压的诊断（研究者确定）
  • 根据最近 HRCT 报告的结果，肺气肿的程度大于纤维化的程度。
  • 筛选前 12 周内或试验期间计划进行的既往肺移植或近期重大手术（研究者确定）的病史。 允许在移植等待名单上登记。
  • 筛选前 4 周内和/或筛选期间需要治疗的临床显着呼吸道感染（例如活动性肺结核、传染性肺炎、2019 年冠状病毒病 [COVID-19]）。
  • 当前或筛选前 3 个月内吸烟（包括电子烟​​）。
  • 当前或慢性肝病或已知的肝脏或胆道异常（吉尔伯特综合征或无症状胆结石除外）。
  • 丙氨酸转氨酶 (ALT)、天冬氨酸转氨酶 (AST)、碱性磷酸酶 (ALP) >2x 正常上限 (ULN) 且胆红素 >1.5xULN（如果胆红素分级且直接胆红素低于 ( <）筛选时为 35%）。
  • 在心电图上检测到节律或传导的临床显着异常，对于在筛查心电图期间进行主动心室起搏的束支传导阻滞和/或起搏器的参与者，校正 QT 间期 (QTc) > 450 毫秒 (msec) 或 QTc > 480 毫秒。
  • 在筛查心电图时未起搏的佩戴起搏器的参与者应具有 <450 毫秒的无起搏 QTc。

先前/伴随治疗-

  • 筛选时同时使用吡非尼酮和尼达尼布。
  • 在筛选期 2 周内接受相当于泼尼松 >10 mg/天或同等剂量的全身皮质类固醇治疗。
  • 在筛选前 4 周内以及筛选期间或研究期间计划使用以下任何疗法：
  • 免疫调节疗法，包括但不限于硫唑嘌呤、吗替麦考酚酯、甲氨蝶呤、他克莫司、环磷酰胺、伊马替尼、肿瘤坏死因子-α(TNF-α)抑制剂。
  • 正在研究治疗 IPF 的药物包括吸入曲前列环素和磷酸二酯酶 4 (PDE-4) 抑制剂。 允许对症咳嗽治疗。
  • 目前正在使用细胞色素 P450 3A4 (CYP3A4) 的全身性强和中度诱导剂或抑制剂（更多信息请参阅禁用药物部分），且在随机分组前至少 14 天无法安全停用或改用替代药物。
  • 目前使用的全身性 CYP3A4 底物的治疗指数较窄，无法在随机分组前至少 14 天安全停用或改用替代药物。

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
实验性的：GSK3915393
Participants received GSK3915393 80 milligrams (mg), orally, twice daily for 26 weeks.
药品：GSK3915393
GSK3915393 was administered.
安慰剂比较：Placebo
Participants received matching placebo, orally, twice daily for 26 weeks.
药品：Placebo
Placebo was administered.

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
Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 26
大体时间：Baseline (Day 1) and Week 26
Forced vital capacity (FVC) is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant was used for calculations. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline (CFB) in FVC at Week 26 was calculated for each participant using the FVC Week 26 result minus the Baseline FVC result. Posterior median CFB and the 95% highest posterior density (HPD) interval were derived using a Bayesian repeated measures model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
Baseline (Day 1) and Week 26

次要结果测量

结果测量
措施说明
大体时间
Absolute Change From Baseline in Forced Vital Capacity at Weeks 4, 8, 12 and 18
大体时间：Baseline (Day 1) and Weeks 4, 8, 12 and 18
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant, at each timepoint was used for calculations. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Posterior median CFB and the 95% HPD interval were derived using a Bayesian repeated measures model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
Baseline (Day 1) and Weeks 4, 8, 12 and 18
Absolute Change From Baseline in FVC (Percentage [%] Predicted) at Weeks 4, 8, 12, 18 and 26
大体时间：Baseline (Day 1) and Weeks 4, 8, 12, 18 and 26
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. The maximum of triplicate FVC for each participant, at each timepoint was used for calculations. The FVC (percentage [%] predicted) result at each timepoint for each participant is calculated using the formula: FVC (% predicted) equals to FVC (mL) divided by Predicted FVC (mL) multiply by 100. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Change from Baseline in FVC (% predicted) at each time point for each participant was calculated by subtracting the Baseline FVC (% predicted) from the FVC (% predicted) at that timepoint.
Baseline (Day 1) and Weeks 4, 8, 12, 18 and 26
Proportion of Participants Who Achieved Relative Decline of Less Than or Equal to (<=) 5% in FVC From Baseline at Week 26
大体时间：Baseline (Day 1) and Week 26
FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It was measured by spirometry test. Baseline was defined as the last non-missing value/assessment prior to the first dose of study treatment on Day 1. Relative decline from Baseline in FVC (mL) at the Week 26 visit was calculated using the following formula: relative decline at Week 26 equals to (1 minus Week 26 FVC [mL] divided by Baseline FVC [mL]) multiplied by 100. Participants with relative decline of <=5% at Week 26 were classified as responders; those with greater than (>) 5% decline were non-responders. Participants who died due to disease progression prior to Week 26 were imputed as non-responders. Posterior median and the 95% HPD interval were derived using a Bayesian logistic regression model. The data presented as "Median" refers to the 'posterior median' and "95% confidence interval" to '95% HPD interval'.
Baseline (Day 1) and Week 26
Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Up to Week 29
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose: 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 in the offspring of a study participant or any other situation according to medical or scientific judgment.
Up to Week 29
Number of Participants With Vital Signs Results by Potential Clinical Importance (PCI) Criteria
大体时间：Up to Week 29
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse rate were measured for at least 5 minutes of rest for the participant in a quiet setting. PCI ranges were SBP (low: less than [<]85 millimeter of mercury [mmHg], high: >180 mmHg), DBP (low: <45 mmHg, high: >110 mmHg) and pulse rate (low: <40 beat per minute [bpm], high: >110 bpm). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose vital signs value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Up to Week 29
Number of Participants With Electrocardiogram (ECG) Results by PCI Criteria
大体时间：Up to Week 29
Triplicate 12-lead ECGs were obtained after participant has rested in supine position for 5 minutes, using an ECG machine that automatically calculates heart rate and measures PR, QRS, QT, and QTc intervals. ECG parameters with PCI ranges were: PR Interval (low: <110 milliseconds[msec], high: >220 msec), QRS Duration (low: <75 msec, high: >120 msec) and QTcF Interval (<=450 msec, >450 msec to <=480 msec, >480 msec to <=500 msec and >500 msec). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Up to Week 29
Number of Participants With Hematology Laboratory Results by PCI Criteria
大体时间：Up to week 29
Hematology parameters with PCI ranges were: hematocrit (low: <0.1 percentage of red blood cells in blood, high: >0.54 percentage of red blood cells in blood), lymphocytes (low: <0.8*giga cells per liter [10^9/L]), neutrophil count (low: <1.5*10^9/L), platelet count (low: <100*10^9/L and high: >800*10^9/L), and white blood cell (WBC) (low: <2*10^9/L and high: >25*10^9/L). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Up to week 29
Number of Participants With Hepatobiliary Laboratory Results by PCI Criteria
大体时间：Up to week 29
Hepatobiliary parameters with PCI ranges were: Alanine transaminase (ALT) (high: greater than or equal to [>=] 3*upper limit of normal [ULN]), Aspartate aminotransferase (AST) (high: >=3*ULN), Alkaline phosphatase (ALP) (high: >=2*ULN) and total bilirubin (high: >=2*ULN). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Up to week 29
Number of Participants With Clinical Chemistry Laboratory Results by PCI Criteria
大体时间：Up to Week 29
Clinical chemistry parameters with PCI ranges were: glucose (low: <2 millimoles per liter[mmol/L], high: >25 mmol/L), albumin (low: <30 grams per liter[g/L]), creatine phosphokinase (CPK) (high: >1500 international units per liter [IU/L]), potassium (low: <3 mmol/L, high: >6.0 mmol/L), sodium (low: <130 mmol/L, high: >155 mmol/L), blood urea nitrogen (BUN) (high: >14 mmol/L) and calcium corrected for albumin (low: <1.9 mmol/L, high: >3 mmol/L). Participants were counted in the worst-case category if their value changed 'To Low' or 'To High', unless there was no change in their category. Participants whose value category was unchanged (e.g., High to High), or whose value became within range, were recorded in 'To Within Range or No Change' category. Participants were counted twice if the participants had values that changed 'To Low' and 'To High', so the percentages may not add to 100%.
Up to Week 29
Maximum Observed Plasma Concentration (Cmax) of GSK3915393
大体时间：Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Blood samples were collected at the indicated nominal time points for pharmacokinetic (PK) analysis of GSK3915393.
Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to 4 Hours (AUC [0-4]) of GSK3915393
大体时间：Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Blood samples were collected at the indicated nominal time points for pharmacokinetic analysis of GSK3915393.
Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Area Under the Plasma-concentration Time Curve From Time Zero (Pre-dose) to Infinity (AUC [0-inf]) of GSK3915393
大体时间：Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2
Blood samples were collected at the indicated nominal time points for pharmacokinetic analysis of GSK3915393.
Pre-dose, 0.5, 1, 1.5, 2, 3, and 4 hours post-dose at Week 2

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

GlaxoSmithKline

调查人员

  • 研究主任：GSK Clinical Trials、GlaxoSmithKline

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)

2024年4月4日

初级完成 (实际的)

2025年10月1日

研究完成 (实际的)

2025年10月1日

研究注册日期

首次提交

2024年3月12日

首先提交符合 QC 标准的

2024年3月12日

首次发布 (实际的)

2024年3月19日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年8月20日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 220929
  • 2023 (美国 NIH 拨款/合同：GRAMMY Museum Foundation)
  • 2023-509371-16-00 (其他标识符：EU CT Number)

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

合格的研究人员可以通过数据共享门户请求访问匿名的个体患者级数据（IPD）和合格研究的相关研究文件。 有关 GSK 数据共享标准的详细信息，请访问：https://www.gsk.com/en-gb/innovation/Trials/data-transparency/

IPD 共享时间框架

对于所有适应症已获批准适应症或终止资产的产品研究，将在主要、关键次要和安全性结果发布后 6 个月内提供匿名 IPD。

IPD 共享访问标准

匿名 IPD 会与研究人员共享，这些研究人员的提案已获得独立审查小组的批准，并且在数据共享协议到位后。 最初提供 12 个月的访问期限，但如有合理理由，可延长最多 6 个月。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 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

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