This is a study to evaluate the effect of CC-90001 compared with placebo on percent of predicted forced vital capacity (FVC) after 24 weeks of treatment in subjects with IPF. Secondary objectives include effects on 6 minute walk test, quality of life questionnaires, disease progression, and safety and tolerability.
There is an 8 week screening phase, a 24 week double blind phase, a 28 week treatment phase, and then a follow up 4 weeks after treatment. In total, there will be 18 total visits to occur over course of about 56 weeks.
The investigational product is 2 pills administered daily with or without food. Common side effects are mild in nature and include GI conditions such as diarrhea, nausea, indigestion, and cramping.
During the initial 24 week double blind period, you will receive either placebo, 200mg or 400mg of active study medication. During the 28 week period, you will receive either 200mg or 400mg of the active study medication. You and your doctor will not know which medication you will be taking.
Criteria:1.) Be 40 years of age or older.
2.) Be diagnosed with IPF within the last 5 years.
3.) Meet screening criteria to include high resolution CT scan imaging that confirms diagnosis, ability to walk 150 meters during the 6 mintue walk test, must comply with study requirements surrounding pregnancy and prevention of pregnancy, and other additional criteria regarding ECG and Spirometry assessments.
There are 2 arms for this study:
1.) Those who are not taking the medications Esbriet and Pirfenidone
2.) Those who have been taking Esbriet for at least 8 weeks (and will continue to take during the trial).