BI 1015550 in People With Idiopathic Pulmonary Fibrosis

The purpose of this study is to find out whether a medicine called BI 1015550 helps people with idiopathic pulmonary fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. 

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. 

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. 

• Study Sponsor: Boehringer Ingelheim
  
  
• Start Date: September 2022
  
  
• Estimated Primary Completion Date: November 2024
  
  
• Phase 3, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with idiopathic pulmonary fibrosis (IPF)

Primary Outcome Measure:

• Absolute change from baseline in Forced Vital Capacity (FVC) (mL) at Week 52 [Time Frame: at baseline, at week 52]

Inclusion Criteria:

• 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) corrected for Haemoglobin (Hb) [Visit 1] ≥25% and <90% predicted of normal at Visit 1.
• Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control. Of note, oral hormonal contraceptives are not considered a highly effective method due to potential drug-drug interactions.

Exclusion Criteria:

• Relevant airways obstruction (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).
• 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.

Further exclusion criteria apply.