Idiopathic Pulmonary Fibrosis is a type of chronic lung disease that primarily causes degeneration of lung function. Common symptoms include an unshakable dry cough and constant shortness of breath. About 5 million people worldwide suffer from this lung disease.
Do you have idiopathic pulmonary fibrosis (IPF)?
This clinical research study is looking at the safety and effectiveness of an investigational medication option for people suffering with IPF.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow up of your condition to monitor the safety and effectiveness of the care you’ll receive. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are age 40 years or older
- Have a current diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
- Are 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
- Have Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1
- Have diffusing capacity (of lung) for carbon monoxide (DLCO) corrected for haemoglobin (Hb) [Visit 1] ≥25% and <90% predicted of normal at Visit 1
You may not qualify to participate in this study if you:
- Have 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, have other clinically significant pulmonary abnormalities
- Have had an acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined)
- Have any relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis
- Have a 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)
- Have had 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
- Have 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
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.