Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis

Korábbi kezelés

• Have previous exposure to seladelpar or cilofexor
• 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.

Más betegség

• Have other causes of liver disease including viral, alcoholic, autoimmune, and metabolic associated steatohepatitis (MASH).
• 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.

Egyéb

• 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.
• Used obeticholic acid, fenofibrate, bezafibrate, elafibranor, pemafibrate, or saroglitazar within 6 weeks (42 days, inclusive) of screening date

• Have a diagnosis of primary biliary cholangitis (PBC) as defined by a history of any 2 of the following criteria:
  • ALP above 1.0 × the ULN for at least 6 months
  • Positive antimitochondrial antibody titer (> 1:40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay) or positive PBC-specific antinuclear antibodies
  • 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