FIBRONEER-IPF: Evaluating an Investigational Drug for Adults with Idiopathic Pulmonary Fibrosis

The FIBRONEER-IPF study will assess an investigational drug to find out if it can help adults with idiopathic pulmonary fibrosis. When a person has idiopathic pulmonary fibrosis, their lungs become scarred and breathing becomes increasingly difficult. This can result in a number of uncomfortable symptoms including shortness of breath, persistent dry cough, tiredness, loss of appetite, and weight loss. The goal of this study is to find out if the investigational drug can help to affect lung function in participants with idiopathic pulmonary fibrosis.

Candidates must be 40 years of age or older and diagnosed with IPF to be considered for this clinical study. Additional criteria will apply.

Those already taking nintedanib or pirfenidone for IPF, may be able to continue treatment throughout the study.

Although this investigational drug has been studied in other clinical research studies, it has not been approved to be prescribed by doctors and other medical professionals. People with IPF can only receive the investigational drug in clinical research studies like these.

This study will test the safety and effectiveness of an oral investigational drug when compared with a placebo for the treatment of idiopathic pulmonary fibrosis (IPF). The placebo looks exactly like the investigational drug but contains no active medication. A computer program will decide which investigational drug each participant will receive at random, so it is possible that you could receive the investigational treatment or placebo.

Participation in the study may last up to approximately two and a half years. Participants will visit a local study center at least 10 times during the first year and every 3 months afterwards. During the study, participants’ health and well-being will be monitored. Participants will also complete tests and assessments like lung function, blood and urine tests, physical exams, and health questionnaires. The study staff will review any side effects that may have occurred in response to taking the study drug.

All study-related visits, tests, and study drugs will be provided at no cost. Reimbursement for study-related travel may be provided.

Approximately 960 participants will take part in this study.