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Trial eligibility change
| eligibility_criteria | Key Inclusion Criteria: * Have a diagnosis of PBC as defined by a history of any 2 of the following criteria: 1. ALP above 1.0 × the ULN for at least 6 months 2. Positive antimitochondrial antibody titer (\> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies 3. Documented liver biopsy results consistent with PBC * Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for \> 6 months prior to screening), or intolerant to UDCA (last dose of UDCA \> 90 days prior to screening) * Have an ALP ≥ 1.67 × ULN at screening * Have a negative serum pregnancy test at screening Key Exclusion Criteria: * Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH). * Cirrhosis with Child-Pugh Score ≥ 7, corresponding to Class B or C. Individuals with compensated cirrhosis (ie, Child-Pugh Class A) are allowed if they meet all other criteria. * Have evidence of portal hypertension or clinically important hepatic decompensation (historic or current), including but not limited to: hepatic encephalopathy, known esophageal or gastric varices, history of liver transplantation, current placement on liver transplant list, Model for End Stage Liver Disease score ≥ 12, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome. * Have previous exposure to seladelpar or cilofexor * Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date * Require or expect to require treatment with ≥ 5 mg prednisone (or systemic equivalents) for \> 2 weeks during the Blinded Treatment or ATE Periods * Are on any systemic drug for antipruritic treatment that has required a dose adjustment in the 30 days before screening, or initiated a systemic antipruritic drug in the 30 days before screening Note: Other protocol defined Inclusion/Exclusion criteria may apply. | → | Key Inclusion Criteria: * Have a diagnosis of primary biliary cholangitis (PBC) as defined by a history of any 2 of the following criteria: 1. ALP above 1.0 × the ULN for at least 6 months 2. Positive antimitochondrial antibody titer (\> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies 3. Documented liver biopsy results consistent with PBC * Used ursodeoxycholic acid (UDCA) for the past 12 months (stable dose for \> 6 months prior to screening), or intolerant to UDCA (last dose of UDCA \> 90 days prior to screening) * Have an ALP ≥ 1.67 × ULN at screening * Have a negative serum pregnancy test at screening Key Exclusion Criteria: * Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH). * Cirrhosis with Child-Pugh Score ≥ 7, corresponding to Class B or C. Individuals with compensated cirrhosis (ie, Child-Pugh Class A) are allowed if they meet all other criteria. * Have evidence of portal hypertension or clinically important hepatic decompensation (historic or current), including but not limited to: hepatic encephalopathy, known esophageal or gastric varices, history of liver transplantation, current placement on liver transplant list, Model for End Stage Liver Disease score ≥ 12, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome. * Have previous exposure to seladelpar or cilofexor * Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date * Require or expect to require treatment with ≥ 5 mg prednisone (or systemic equivalents) for \> 2 weeks during the study * Are on any systemic drug for antipruritic treatment that has required a dose adjustment in the 30 days before screening, or initiated a systemic antipruritic drug in the 30 days before screening Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
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