Clinical Research Studies

This is an open label, uncontrolled, international multicenter long-term observational study. The study will include subjects who participated in a previous PBC study with seladelpar (CB8025-21629, CB8025-31735, or CB8025-21838) or future PBC studies with seladelpar that allow rollover into CB8025-31731, allowing their treatment to continue. Subjects who were previously on placebo in CB8025-31735 can choose to participate in this study as long as they meet eligibility criteria. Qualified subjects will receive 10 mg seladelpar. Subjects with noted tolerability issues may receive seladelpar 5 mg if in the opinion of the Investigator, that would be the appropriate starting dose. Subjects on 5 mg may be up-titrated to 10 mg after a period of clinical stability if the Investigator deems it medically appropriate and after consultation with the Medical Monitor. Subjects can be down-titrated from 10 mg to 5 mg throughout the study for reasons of safety or tolerability. They can also be re-challenged with 10 mg if the reason for prior down-titration has resolved. Treatment can also be re-initiated after dose interruption if it is agreed to be medically appropriate by consultation between the Investigator and Medical Monitor. Potential adjustment of doses for safety or tolerability will be managed as outlined in the study protocol. Subjects will continue ursodeoxycholic acid (UDCA) intake in accordance with their prescribed dose. Subjects will be evaluated for pruritus and QoL throughout the duration of study participation. Subjects will be regularly evaluated for PBC clinical outcomes. Subjects who meet any PBC clinical outcome per the study protocol will discontinue seladelpar. Subjects who discontinue seladelpar anytime during the treatment period will be asked to stay in the study to collect PBC clinical outcomes. The primary objective of the study is to evaluate the long-term safety and tolerability of seladelpar.