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Um estudo para avaliar a eficácia e segurança de GSK3915393 em participantes com fibrose pulmonar idiopática (FPI)

20 de agosto de 2026 atualizado por: GlaxoSmithKline

Um estudo de fase 2, randomizado, duplo-cego, controlado por placebo, de grupo paralelo (TRANSFORM) para avaliar a eficácia e segurança de GSK3915393 em participantes com fibrose pulmonar idiopática (FPI)

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.

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

158

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: GSK3915393

Participants received GSK3915393 80 milligrams (mg), orally, twice daily for 26 weeks.
Medicamento: GSK3915393

GSK3915393 was administered.
Comparador de Placebo: Placebo

Participants received matching placebo, orally, twice daily for 26 weeks.
Medicamento: Placebo

Placebo was administered.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Absolute Change From Baseline in Forced Vital Capacity at Weeks 4, 8, 12 and 18
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

GlaxoSmithKline

Investigadores

  • Diretor de estudo: GSK Clinical Trials, GlaxoSmithKline

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de abril de 2024

Conclusão Primária (Real)

1 de outubro de 2025

Conclusão do estudo (Real)

1 de outubro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

12 de março de 2024

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de março de 2024

Primeira postagem (Real)

19 de março de 2024

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 220929
  • 2023-509371-16-00 (Outro identificador: EU CT Number)
  • 2023 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

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.

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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