Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

Ki vehet részt

• 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

Ki nem vehet részt

• Liver transplant recipients
• Drug-induced liver pruritus
• History of intrahepatic cholestasis of pregnancy
• Any form of chronic hepatic pruritus associated with underlying malignancy
• 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
• Any form of acute cholestatic liver disease
• Allergy to nemolizumab or its ingredients
• ALT or AST greater than 3 times the upper limit of normal or total bilirubin greater than 2 times upper normal limit
• Severe coagulopathy with INR > 15
• 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
• Inability to provide informed consent