PSCNot yet recruiting
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Phase 2 · Testing Nemolizumab-ilto · 1 site · Mayo Clinic
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Nemolizumab-ilto (a drug) as a possible treatment. Condition(s) listed: Chronic Hepatic Pruritus, Cholestatic Liver Disease and Primary Biliary Cholangitis.
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 15 participants are expected to take part.
- The study has 1 group.
- Start date: 2026-11 (planned).
- Main results expected around 2028-11 (estimate from the record).
- 1 study site listed in United States.
Groups in this study
- Nemolizumab-ilto (listed as: experimental group)
Main thing being measured
- Mean percent change in the Peak Pruritus Numerical Rating Score (PNRS) (Baseline to Week 16)
In the researchers’ words
The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.
Words you might see
- ULN: upper limit of normal: the top of the usual range for a lab test.
- Bilirubin: a yellow substance measured in blood; high levels can be a sign of liver or bile-duct problems.
- MELD score: a score based on lab tests used to estimate how severe liver disease is.
- Decompensated liver disease: advanced liver disease with complications such as fluid build-up or bleeding.
- Pruritus: itching; a common and often hard-to-treat symptom in cholestatic liver disease.
- Cholestasis: reduced or blocked flow of bile.
- INR: a blood test of how quickly blood clots; it can reflect liver function.
- Biopsy / histology: a small tissue sample examined under a microscope.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Chronic Hepatic Pruritus; Cholestatic Liver Disease; Primary Biliary Cholangitis; Cholestasis; Primary Sclerosing Cholangitis |
| Lead sponsor | Mayo Clinic |
| Enrollment | 15 (estimated) |
| Start date | 2026-11 |
| Primary completion (est.) | 2028-11 |
| First posted | 2026-09-28 |
| Last updated | 2026-09-28 |
| Official title | Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: An Open-Label, Single-Arm, Exploratory Study |
| ClinicalTrials.gov ID | NCT07843420 |
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).
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic | Jacksonville, Florida | United States |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.