The RESPONSE study is being conducted at more than 100 locations throughout the world. Find a location near you and see if you might be eligible to participate.
To qualify for the RESPONSE study you must:
- Be 18 to 75 years old (inclusive)
- Be diagnosed with PBC
- Have been on a stable and recommended dose of UDCA or you were required to stop taking the medication
- Have blood laboratory test results in the following range:
- Alkaline phosphatase (ALP) at least 1.67 times the upper limit of normal (ULN)
- Bilirubin test levels less than two times the ULN
Doctors will check other requirements to confirm that you qualify for this study.
If you are currently taking UDCA you will continue to take your UDCA at the same and recommended dose during study participation. During the study, you will be reimbursed for your UDCA for 12 months. You will also begin to take seladelpar or placebo, orally (by mouth) once a day for 52 weeks. At the end of the study, you may be given the opportunity to participate and receive seladelpar in the open label ASSURE long-term study (CB8025-31731-RE).
There is no guarantee at this point in time that being treated with seladelpar will have any effect on your PBC. There is also a 1 in 3 chance you will receive placebo in this study. Placebo is an inactive substance that looks like seladelpar. During the study neither you nor your doctor will know if you are receiving placebo or seladelpar.