Nemolizumab for Moderate to Severe Itching Caused by Chronic Liver Disease
Tests nemolizumab in adults with moderate to severe chronic itching from liver disease.
Plain-language title generated from the registry record
Registry title: Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Key facts
- Where
- Jacksonville, United StatesSee the site
- Phase
- Phase 2
Where in United States
- Mayo ClinicJacksonville, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mayo Clinic
- Trial code
- NCT07843420
- Record updated
- 28 September 2026
- Original description
The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.Read full original descriptionShow less
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: An Open-Label, Single-Arm, Exploratory Study
The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.
Inclusion: 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: 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.