A Phase 2, 24-Week Randomized, Double-blind, Placebo-Controlled Multicenter Study, Followed by a 28-Week Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Idiopathic Pulmonary Fibrosis
Dr Gauri Saini is leading this study for us in Nottingham along with Lucy Howard.
What is the purpose of this trial?
The purpose of this study is to test an investigational (being tested) drug called CC-90001; CC-90001 has not been approved for the treatment of idiopathic pulmonary fibrosis (IPF).
This study will test CC-90001 (at doses of either 200 mg or 400 mg, given by mouth, once daily) compared to placebo, an inactive substance that contains no medicine. This study is being conducted to test the effect of CC-90001 on improving your breathing and whether it can slow down further worsening of your disease (IPF), and to see how well your body tolerates CC-90001.
This study also includes testing of blood samples for biomarkers. Biomarkers are substances such as proteins in the blood that tell us how the drug is working in your body. The biomarker testing is mandatory. That means that you cannot participate in the study if you do not agree to participate in the biomarker testing.
This study is now fully completed