The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.
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
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
Single group
Nemolizumab-ilto
DrugParticipants will receive nemolizumab-ilto 60 mg subcutaneously at Week 0, followed by 30 mg subcutaneously every 4 weeks during the treatment period (total of 16 weeks).
Mean percent change in the Peak Pruritus Numerical Rating Score (PNRS)
Pruritus severity is measured using the peak PNRS, a single self-administered item that captures the intensity of the worst itch experienced during the previous 24 hours. Patients respond to the question: "On a scale of 0 to 10, with 0 being 'no itch' and 10 being 'worst itch imaginable,' how would you rate your itch at the worst moment during the previous 24 hours?" Patients will record daily itch scores in a diary, which will be collected at follow-up visits. The baseline and Week 16 mean peak PNRS values will be calculated as the average of the daily scores recorded over the 7 days immediately preceding treatment initiation and 7 days preceding Week 16 follow up, respectively.
Percentage of patients with an improvement in weekly average PNRS ≥4 from baseline
The proportion of participants with an improvement of at least 4 points from baseline in weekly average Peak Pruritus Numerical Rating Score will be assessed at each specified post-baseline time point.
Change in Verbal Rating Scale of Pruritus
The Verbal Rating Scale of pruritus is assessed using a 4-point scale where 0 indicates none, 1 indicates mild, 2 indicates moderate, and 3 indicates severe or intense pruritus. Change from baseline will be summarized at each specified post-baseline time point.
Mean change of 5D pruritus score
This is a multidimensional questionnaire designed to assess the degree, duration, direction, disability and distribution of pruritus longitudinally with scoring ranging from 5=no pruritus/well-controlled to 25=severe pruritus/poorly controlled.
Change in Chronic Liver Disease Questionnaire (CLDQ) score
This is a validated quality life instrument for patients with chronic liver disease evaluating systemic symptoms, fatigue, physical activity, emotional function, and worry using a 7 point scale with 1=all of the time; 2=most of the time; 3=a good bit of the time; 4=some of the time; 5=a little of the time; 6=hardly any of the time; and 7=none of the time.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
