Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

NCT07843420 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 26-003510
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.

Conditions

Chronic Hepatic Pruritus; Cholestatic Liver Disease; Primary Biliary Cholangitis; Cholestasis; Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 16

Secondary Outcomes (5)

• Percentage of patients with an improvement in weekly average PNRS ≥4 from baseline

  Weeks 1,2,4,8, and 12

• Change in Verbal Rating Scale of Pruritus

  Weeks 1,2,4,8, and 12

• Mean change of 5D pruritus score

  Baseline, Week 12

• Change in Chronic Liver Disease Questionnaire (CLDQ) score

  Baseline, Week 12

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Item Bank mean score

  Baseline, Week 12

Study Arms (1)

Nemolizumab-ilto

EXPERIMENTAL

Participants will receive open-label nemolizumab-ilto by subcutaneous injection.

Drug: Nemolizumab-ilto

Interventions

Nemolizumab-ilto DRUG

Participants 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).

Also known as: NEMLUVIO

Nemolizumab-ilto

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Cholestasis; Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cholangitis

Study Officials

• Jason Sluzevich, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reagan E. Dukes, MHA

CONTACT

904-953-3302; dukes.reagan@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)