A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)

Korábbi kezelés

• Acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).
• 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.

Más betegség

• Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.
• 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.

Laborértékek

• 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.
  • Further exclusion criteria apply.

Egyéb

• 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.

• 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.