Clinical Research Directory

Inclusion Criteria: * Cholestatic pruritus secondary primary biliary sclerosis (PBS) or primary sclerosing cholangitis (PSC) * Pruritus that is chronic in duration (greater equal to 6 months) * Pruritus severity with a peak pruritus numerical rating score of ≥ 5 (moderate severity) * Model for End-Stage Liver Disease (MELD) score \< 15. This will capture patients with chronic stable liver disease without significant comorbid conditions and/or signs of rapidly progressive or decompensated liver failure * Willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, effective contraception use, and other trial procedures Exclusion Criteria: * Pruritus due to a primary inflammatory skin dermatosis or other forms of psychogenic pruritus utilizing skin biopsies to exclude as needed * Pregnant females. Urine pregnancy test required at screening * History of intrahepatic cholestasis of pregnancy * Any form of chronic hepatic pruritus associated with underlying malignancy * Liver transplant recipients * Drug-induced liver pruritus * ALT or AST greater than 3 times the upper limit of normal or total bilirubin greater than 2 times upper normal limit * Advanced liver disease indicators including, ascites requiring therapeutic paracentesis, history of spontaneous bacterial peritonitis, any grade of hepatic encephalopathy, or a documented history of variceal bleeding within the preceding six months * Severe coagulopathy with INR \> 15 * Any form of acute cholestatic liver disease * Allergy to nemolizumab or its ingredients * Inability to provide informed consent