Resumen

Este estudio está abierto a adultos con enfermedades pulmonares intersticiales fibrosantes progresivas (PF-ILD). Las personas que tengan una forma de PF-ILD distinta de la fibrosis pulmonar idiopática (IPF) pueden participar en el estudio. Si ya reciben tratamiento con nintedanib, pueden continuar el tratamiento durante todo el estudio. El propósito de este estudio es determinar si un medicamento llamado BI 1015550 beneficia a las personas con PF-ILD. Los participantes se asignan a 3 grupos de forma aleatoria, lo que significa al azar. Los participantes de 2 grupos toman diferentes dosis de BI 1015550 en forma de comprimidos dos veces al día. Los participantes del 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 centro del estudio 10 veces. Posteriormente, visitan el centro del estudio cada 3 meses. Los médicos evalúan periódicamente la función pulmonar de los participantes. Los resultados de las pruebas de función pulmonar se comparan entre los grupos. Los médicos también controlan periódicamente la salud de los participantes y registran cualquier efecto no deseado.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients ≥18 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 progressive fibrosing ILD other than IPF (physician confirmed).
Patients may be either:
on a stable therapy\* with nintedanib for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. (\*stable therapy is defined as a tolerated regimen of nintedanib (with no dose changes) for at least 12 weeks)
not on treatment with nintedanib 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.
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
Patients treated with permitted immunosuppressive agents (other than corticosteroids) for an underlying systemic disease (e.g. Methotrexate (MTX), Azathioprine (AZA)) need to be on a stable treatment for at least 12 weeks prior to Visit 1 and during the screening period.

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 Interstitial Lung Disease (ILD) 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.
Patients having developed ILD due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection/coronavirus disease 2019 (COVID-19) within 12 months of screening (based on investigators judgement).
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, in the morning and in the evening.

drug

Placebo

Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally, twice daily, in the morning and in the evening.

Ubicaciones

Hospital Italiano de Buenos Aires

CABA, Argentina

Consultorios Médicos del Buen Ayre

Capital Federal, Argentina

APRILLUS-Asistencia e Investigacion

Ciudad Autonoma Buenos Aires, Argentina

CEMER-Centro Medico De Enfermedades Respiratorias

Florida, Argentina

Instituto Ave Pulmo

Mar del Plata, Argentina

INSARES

Mendoza, Argentina

Centro Respiratorio de Quilmes

Quilmes, Argentina

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

C.a.b.a, Argentina

CEDIC - Centro de Investigacion Clinica