Summary:
A clinical research study for people with idiopathic pulmonary fibrosis, or IPF.
The purpose of this study is to evaluate the safety, effectiveness and tolerability of a potential medicine, called HZN-825, that may slow disease progression in participants with IPF. Participants will be chosen at random to receive either the potential medicine or a placebo, which looks just like the potential medicine but does not contain active ingredients. Both the potential medicine and the placebo are tablets taken orally twice daily.
Participants will be asked to attend 12 visits to the study site and have two phone calls with the study team throughout the study. The total length of participation is approximately 64 weeks and consists of a screening period, treatment period and safety follow-up period.
If you qualify for this clinical research study, you will receive all study-related medications and procedures at no cost. In order to reduce trips to the study site, you and your study doctor may choose to have some of the study visits at your home with a home health nurse. You may also be compensated financially for your study-related time and reimbursed for travel.
Eligibility Criteria:
- Male or female between the ages of 18 and 80 (inclusive) at screening
- Currently diagnosed with IPF (the date of initial diagnosis of IPF should be between one and seven years before screening)
- Not currently being treated with specific IPF medicines due to:
- Intolerance or not responding to approved IPF medicines
- Ineligibility to receive approved IPF medicines
- Declining approved IPF medicines
- No cancerous conditions in the past five years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer)
Other protocol-defined inclusion and exclusion criteria may apply.