Study of Seladelpar in Participants With Primary Biliary Cholangitis (PBC)

Exclusion Criteria

• •1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar
• •2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results (eg, cancer, any active infection)
• •3. AST or ALT above 3 × the upper limit of normal (ULN)
• •4. Total bilirubin above 2 × ULN
• •5. MELD score ≥ 12. For individuals on anticoagulation medication, evaluation of the baseline INR, in concert with any current dose adjustments in anti-coagulant medications, will be taken into account when calculating this score. This will be done in consultation with the medical monitor.
• •6. Evidence of advanced PBC as defined by the Rotterdam criteria: albumin below 1× the lower limit of normal (LLN) AND total bilirubin above 1 × ULN)
• •7. eGFR ≤45 mL/min/1.73 m2 (calculated by MDRD formula)
• •8. Auto-immune hepatitis
• •9. Primary sclerosing cholangitis
• •10. Known history of alpha-1-antitrypsin deficiency
• •11. Known history of chronic viral hepatitis
• •12. For females, pregnancy or breast-feeding
• •13. Use of colchicine, methotrexate, azathioprine, or long-term use of systemic steroids (eg prednisone, prednisolone, budesonide) (\>2 weeks) within 2 months prior to Screening
• •14. Current use of fibrates or use of fibrates within 3 months prior to Screening
• •15. Current use of obeticholic acid or use of obeticholic acid within 3 months prior to Screening
• •16. Use of an experimental or unapproved treatment for PBC within 3 months prior to Screening
• •17. History of malignancy diagnosed or treated, actively or within 2 years, or active evaluation for malignancy; localized treatment of squamous or non-invasive basal cell skin cancers and cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
• •18. Treatment with any other investigational therapy or medical device within 30 days or within 5 half-lives, whatever is longer, prior to Screening
• •19. Any other condition(s) that would compromise the safety of the individual or compromise the quality of the clinical study, as judged by the Investigator
• •20. Immunosuppressant therapies (eg, cyclosporine, tacrolimus, anti-TNF or other immunosuppressive biologics)
• •21. Other medications that effect liver or GI functions such as absorption of medications or the roux-en-y gastric bypass procedure may be prohibited and should be discussed with the medical monitor on a case-by-case basis
• •22. Positive for:
• •1. Hepatitis B, defined as the presence of hepatitis B surface antigen
• •2. Hepatitis C, defined as the presence of hepatitis C virus ribonucleic acid (RNA)
• •3. Human immunodeficiency virus (HIV) antibody
• •23. Active COVID-19 infection during screening