Study to Evaluate the Safety and Efficacy of Oral CR845 (Difelikefalin) in Patients With Primary Biliary Cholangitis (PBC) and Moderate-to-Severe Pruritus

This is an interventional treatment trial for Cholestatic Pruritus focused on measuring Primary Biliary Cholangitis, Pruritus, CR845, Chronic Itch, difelikefalin, Itch, Itching, Generalized pruritus Read More

Key Inclusion Criteria:

To be eligible for inclusion into the study, a patient must meet the following criteria:

• Confirmed diagnosis of PBC;
• If currently taking ursodeoxycholic acid (UDCA), should be on stable dose for >12 weeks prior to screening and plan on continuing to take UDCA throughout the study;
• If previously taking UDCA, should have discontinued its use >12 weeks prior to screening;
• Self-reports experiencing daily or near-daily pruritus during the month prior to screening;
• Prior to randomization has a mean baseline WI-NRS score indicative of moderate to severe pruritus.

Key Exclusion Criteria:

A patient will be excluded from the study if any of the following criteria are met:

• Presence of Child-Pugh Class C decompensated cirrhosis at screening;
• Itching secondary to biliary obstruction;
• History or presence of hepatocellular carcinoma, hepatic abscess, or acute portal vein thrombosis;
• Current placement on liver transplantation list with anticipated liver transplant during the course of the study or current Model for End-stage Liver Disease (MELD) score ≥15;
• Alanine aminotransferase or aspartate aminotransferase >5 × upper limit of normal at screening, or within 2 months prior to screening;
• Anticipates receiving an opioid antagonist (eg, naloxone, naltrexone) or opioid-mixed agonist-antagonist (eg, buprenorphine, nalbuphine) from the start of screening through the end of the Treatment Period;
• New or change of treatment with antihistamines and corticosteroids (oral, intravenous, or topical), opioids, gabapentin, pregabalin, cholestyramine, rifampicin or fibrates within 14 days prior to screening.