Chronic Hepatic PruritusPhase 2NCT07843420
Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
A Phase 2 study testing Nemolizumab-ilto in people with Chronic Hepatic Pruritus and Cholestatic Liver Disease, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatic Pruritus, Cholestatic Liver Disease, Primary Biliary Cholangitis
- What is being tested?
- Nemolizumab-ilto
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Chronic Hepatic Pruritus, Cholestatic Liver Disease, Primary Biliary Cholangitis, Cholestasis, Primary Sclerosing Cholangitis
- Being tested
- Nemolizumab-ilto
- Medical subject headings
- Liver Cirrhosis, Biliary, Cholestasis, Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nemolizumab-iltoDrug
Also called NEMLUVIO
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).
| Study group | Role | What they receive |
|---|---|---|
| Nemolizumab-ilto | Experimental | Participants will receive open-label nemolizumab-ilto by subcutaneous injection. Receives: Drug: Nemolizumab-ilto |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 16
Secondary outcomes (5)
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.
Measured: Weeks 1,2,4,8, and 12
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.
Measured: Weeks 1,2,4,8, and 12
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.
Measured: Baseline, Week 12
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.
Measured: Baseline, Week 12
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Item Bank mean score
The Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Item Banks assess a wide spectrum of self-reported fatigue symptoms, ranging from mild feelings of tiredness to overwhelming, debilitating, and sustained exhaustion that can significantly impair an individual's ability to perform daily activities and fulfill family or social roles. Each item is rated on a 5-point Likert scale, and the resulting raw scores are converted into T-scores, which are then compared to a standardized mean (T-score mean = 50, SD = 10).
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatic PruritusStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Sluzevich MD, Mayo Clinic
- Investigators
- Jason Sluzevich, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843420
- Sponsor's protocol ID
- 26-003510
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No