Resumen

Este estudio está abierto a adultos con una enfermedad pulmonar denominada Fibrosis Pulmonar Idiopática (FPI). Las personas pueden unirse al estudio si tienen 40 años o más. Si ya toman nintedanib o pirfenidona para su FPI, pueden continuar con el tratamiento durante todo el estudio. El objetivo de este estudio es determinar si un medicamento llamado BI 1015550 ayuda a las personas con FPI. Los participantes son asignados aleatoriamente a 3 grupos, lo que significa que es por azar. Los participantes en 2 grupos toman diferentes dosis de BI 1015550 en comprimidos dos veces al día. Los participantes en el grupo placebo toman comprimidos de placebo dos veces al día. Los comprimidos de placebo tienen el mismo aspecto que los comprimidos de BI 1015550, pero no contienen ningún medicamento. Los participantes permanecen en el estudio hasta dos años y medio. Durante el primer año, visitan el sitio del estudio 10 veces. Posteriormente, visitan el sitio del estudio cada 3 meses. Los médicos realizan pruebas periódicas de la función pulmonar de los participantes. Los resultados de las pruebas de función pulmonar se comparan entre los grupos. Los médicos también controlan regularmente la salud de los participantes y registran cualquier efecto no deseado.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Patients ≥40 years old at the time of signed informed consent.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
Patients may be either:
on a stable therapy\* with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed. (\*stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks).
not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.
Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.
Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.
Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.

Criterios de exclusión

Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) \<0.7 at Visit 1.
In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
Acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) not fully recovered according to investigator judgement within the 4 weeks prior to randomization (Visit 2).
Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery.
Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.
Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) \>2.5 x Upper limit of normal (ULN) or total Bilirubin \>1.5 x ULN at Visit 1.

Intervenciones

drug

BI 1015550

Participants received film-coated nerandomilast tablets orally twice daily at doses of either 9 mg or 18 mg, with each dose administered at least 12 hours apart and taken with 250 mL of water.

drug

Placebo

Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.

Ubicaciones

Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553

C.a.b.a, Argentina

CEDIC - Centro de Investigacion Clinica

CABA, Argentina

Hospital Italiano de Buenos Aires

CABA, Argentina

Consultorios Médicos del Buen Ayre

Capital Federal, Argentina

Instituto Ave Pulmo

Mar del Plata, Argentina

INSARES

Mendoza, Argentina

Centro Respiratorio de Quilmes

Quilmes, Argentina

Un Ensayo Doble Ciego, Aleatorizado, Controlado con Placebo que Evalúa la Eficacia y Seguridad de BI 1015550 durante al Menos 52 Semanas en Pacientes con Fibrosis Pulmonar Idiopática (FPI)