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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

Idiopathic Pulmonary Fibrosis is a chronic lung disease which causes scarring of the lungs and difficulty in breathing. GSK3915393 is a new medicine, which is being tested in participants with IPF for the first time. The study will assess the safety and effectiveness of GSK3915393 in IPF participants.

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

18年 及以上 (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:

  • Participants with IPF diagnosed within 5 years prior to screening based on the applicable American Thoracic Society (ATS)/ European Respiratory Society (ERS)/ Japanese Respiratory Society (JRS)/ Latin American Thoracic Society (ALAT) Guideline at the time of diagnosis.
  • Centrally read chest High Resolution Computed Tomography (HRCT) obtained at screening or historical HRCT obtained within 12 months of screening that is consistent with Usual interstitial pneumonia (UIP) or probable UIP (if indeterminate HRCT finding, IPF may be confirmed locally by historical biopsy).
  • FVC greater than or equal to (>=) 45 percent (%) of predicted normal.
  • Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) >=25% of predicted normal corrected for hemoglobin (Hb).
  • Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC >=0.7.
  • If receiving antifibrotics must be on stable dose of nintedanib or pirfenidone for at least 12 weeks prior to screening.
  • If not receiving approved antifibrotics (pirfenidone or nintedanib) there should be a valid reason for this, such as previous failure, contraindications, failure to meet national or regional eligibility criteria for anti-fibrotic treatment, or participant choice.
  • If not currently receiving pirfenidone or nintedanib, participant must have stopped pirfenidone or nintedanib for at least 4 weeks prior to screening.
  • Body weight >=40 kilogram (kg) and body mass index within the range 18.5-35 kilogram per meter square (kg/m^2) (inclusive).
  • A female participant is eligible to participate if a woman of nonchildbearing potential (WONCBP)
  • Capable of giving signed informed consent

Exclusion Criteria:

  • Participants with Interstitial Lung Disease (ILD) associated with other known causes.
  • Diagnosis of sarcoidosis or any systemic autoimmune disease (including but not limited to scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus and rheumatoid arthritis).
  • Acute IPF exacerbation within 6 months prior to screening and/or during the screening period (investigator-determined).
  • Clinically significant non-parenchymal lung disease (e.g., asthma, chronic obstructive pulmonary disease, cavitary or pleural diseases) at screening.
  • Diagnosis of severe pulmonary hypertension (investigator-determined)
  • Extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent HRCT.
  • History of previous lung transplant or recent major surgery (investigator-determined) within 12 weeks prior to screening or planned during the trial period. Registration on a transplant waiting list is allowed.
  • Clinically significant respiratory tract infection (e.g., active tuberculosis, infectious pneumonia, Corona virus disease 2019 [COVID-19]) requiring treatment within 4 weeks prior to and/or during the screening period.
  • Cigarette smoking (including e-cigarettes) either current or within 3 months before screening.
  • Current or chronic liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Alanine transaminase (ALT), Aspartate transaminase (AST), Alkaline phosphatase (ALP) greater than (>) 2x Upper Limit of Normal (ULN) and bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin less than (<) 35% at screening).
  • Clinically significant abnormalities detected on ECG of either rhythm or conduction, a Corrected QT interval (QTc) >450 millisecond (msec) or QTc > 480msec for participants with a bundle branch block and/or a pacemaker who are actively ventricularly pacing during the screening ECG.
  • Participants with pacemakers who are not pacing at the time of the screening ECG should have a non-paced QTc <450 msec.

Prior/Concomitant Therapy-

  • Simultaneous use of pirfenidone and nintedanib at screening.
  • Received systemic corticosteroids equivalent to prednisone >10 milligrams/day or equivalent within 2 weeks of screening period.
  • Use of any of the following therapies within 4 weeks prior to screening and during the screening period or planned during the study:
  • Immunomodulatory therapies, including but not limited to azathioprine, mycophenolate mofetil, methotrexate, tacrolimus, cyclophosphamide, imatinib, Tumour Necrosis Factor -Alpha (TNF- α) inhibitors.
  • Medications that are under investigation for the treatment of IPF including inhaled treprostinil and Phosphodiesterase-4 (PDE-4) inhibitors. Symptomatic cough therapies are allowed.
  • Current use of systemic strong and moderate inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4) that cannot be safely discontinued or switched to an alternative agent at least 14 days before randomization.
  • Current use of systemic CYP3A4 substrates that have a narrow therapeutic index that cannot be safely discontinued or switched to an alternative agent at least 14 days before randomization.

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

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

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to gsk-patient-level-data-sharing-july2025.pdf

IPD 共享时间框架

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD 共享访问标准

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

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

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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