Resumen

This study is open to adults with Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs). People who have a form of PF-ILD other than Idiopathic Pulmonary Fibrosis (IPF) can join the study. If they already take nintedanib, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with PF-ILD. Participants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine. Participants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects.

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

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

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

Instituto Médico de la Fundación Estudios Clínicos

Rosario, Argentina

A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs)