The purpose of this study is to test an experimental drug called CC-90001. 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 IPF, and to see how well your body tolerates CC-90001.
This study is being conducted in order to to create and maintain a database (a searchable collection of information) of subjects with interstitial lung disease (ILD) that collects and stores their medical information, and other related information to use in medical research.
The study is a registry in which the study team will collect information from subjects, but there will be no treatment or intervention involved. Males and females from the ages of 18 years or older diagnosed with ILD are eligible.
This research study includes adults (18 years of age or older) with Idiopathic Pulmonary Fibrosis (IPF). The study is being conducted to find out if KD025 is a safe and effective treatment. Participants will be put on the study drug, KD025, for about 24 weeks (followed by another 24 weeks on KD025 if tolerated well). They will be on a daily dose of 400mg (by mouth) and in previous tests have shown to reduce IPF and inflammation.
The purpose of this research registry is to better understand the natural history of Idiopathic Pulmonary Fibrosis and current practice patterns. The IPF-PRO registry will be used to collect data and biological samples that will support future research studies by identifying disease biomarkers for IPF. Through these studies, researchers hope to find new ways to detect, treat, and maybe prevent or cure health problems. Some of these studies may be about how genes affect health and disease, or how a person's genes affect their response to a treatment. Some of these studies may lead to new products, such as drugs or tests for diseases. We are asking you to let us collect and store some of your blood and health information so they might be used in these kinds of future studies.
If you are newly diagnosed with IPF and are eligible for participation in IPF-PRO, you will be asked to sign a consent form to become enrolled if you agree to be in this registry. At enrollment a member of MUSC research staff will collect information from you and about your medical history and medical care, as well as information about the types of health insurance (public or private) that you have. As part of your participation in this registry, you will be required to sign a medical release form giving permission for your medical records to be reviewed for the purposes of data collection for the registry. This is an observational registry which means you will not receive any investigational treatments or investigational drugs, and only minimally invasive procedures will be performed (blood draws) at scheduled clinic visits. In addition to the face to face visits for self-administered participant reported questionnaires and blood collection, at roughly 6-month intervals, sites will review the participant's medical records. Your disease management and treatment decisions will be determined by you and your health care professional. Subjects will be followed until the last enrolled subject has been followed for 3 years up to a maximum of 5 years.