PERSEUS: Preliminary Efficacy and Safety of Cenicriviroc in Adult Participants With Primary Sclerosing Cholangitis

Exclusion Criteria

• •Presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis, recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis, surgical or blunt abdominal trauma, recurrent pyogenic cholangitis, choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other cause of secondary sclerosing cholangitis) on prior clinical investigations
• •Small duct PSC
• •Presence of percutaneous drain or bile duct stent
• •History of cholangiocarcinoma or high clinical suspicion over dominant stricture within 1 year by MRCP/ERCP or clinical judgment
• •Ascending cholangitis within 60 days prior to Screening
• •Alcohol consumption greater than 21 units/week for males or 14 units/week for females (one unit of alcohol is ½ pint of beer \[285 mL\], 1 glass of spirits \[25 mL\] or 1 glass of wine \[125 mL\])
• •Prior or planned liver transplantation
• •Presence of alternative causes of chronic liver disease, including alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, autoimmune hepatitis
• •History of cirrhosis and/or hepatic impairment (Child-Pugh classes A, B and C) and/or hepatic decompensation including ascites, encephalopathy or variceal bleeding. Participants who show evidence of significant worsening of hepatic function will be excluded
• •Participants with fibrosis evidence of cirrhosis, as determined by local transient elastography (TE, e.g., Fibroscan) values of ≥ 13.0 kPa, taken within the last 6 months. If TE has not been conducted within the 6 months prior to screening, then one will be conducted during the screening period and can be used as the Baseline value.
• •Moderate to Severe active IBD or flare in colitis activity within the last 90 days requiring intensification of therapy beyond Baseline treatment. Participants with stable mild to moderate IBD, who are on treatment, are allowed provided they are stable for 3 months with 5-amino salicylic acid drugs or Azathioprine (allowed dose of azathioprine is 50-200 mg/day)
• •Use of oral prednisolone \> 10 mg/day, biologics and/or hospitalization for colitis within 90 days are disallowed
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT); above the allowed cut-offs, as determined by Screening values:
• •* AST \> 200 IU/L males and females
• •* ALT: males \> 250 IU/L and females \> 200 IU/L
• •Total Bilirubin and Direct Bilirubin; above the allowed cut-offs, as determined by Screening values:
• •* Total Bilirubin \> 2.0 mg/dL
• •* Direct Bilirubin \> 0.8 mg/dL
• •International normalized ratio \> 1.3 in the absence of anticoagulants
• •Immunoglobulin G4 (IgG4) \> 4 × ULN at Screening or evidence of IgG4-related sclerosing cholangitis
• •Females who are pregnant or breastfeeding
• •Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing and protocol requirements