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A double blind, randomized, placebo-controlled trial evaluating the efficacy and safety of BI 1015550 over at least 52 weeks in patients with Idiopathic Pulmonary Fibrosis (IPF)
Recruiting
The purpose of this trial is to evaluate the efficacy, safety, and tolerability of BI 1015550 9 mg bid and 18 mg bid compared to placebo in patients with IPF in addition to patient’s standard of care over the course of at least 52 weeks. New treatments with better tolerability are needed for patients with IPF to further reduce the decline in lung function and improve quality of life. Based on its anti-inflammatory and antifibrotic properties and the preliminary clinical evidence described, BI 1015550 may provide an additional treatment option to patients with pulmonary fibrosis irrespective of concomitant treatment with standard of care.
All
40 Years to old
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).
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.
Idiopathic Pulmonary Fibrosis
Clinics and Surgery Center (CSC)
Mandi DeGrote - carl1032@umn.edu
Hyun Kim
Phase III
STUDY00016653
STUDY00016653
See this study on ClinicalTrials.gov