Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

November 10, 2025 updated by: Jason Sluzevich MD, Mayo Clinic

Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: an Open-Label, Single-Arm, Exploratory Study

To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a 22-week (2 week screening, 18-week treatment period followed by a 2 week followup), phase II, open label, exploratory study to investigate the potential efficacy of FDA approved dupilumab in the treatment of adults with moderate to severe chronic hepatic pruritus. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this trial. Once consent has been obtained, baseline values will be established and subjects will begin treatment and follow-up for the next 20 weeks. A final visit will be needed for evaluation and questionnaire completion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and/or female subjects 18 years or older with chronic pruritus of moderate to severe severity in the setting of intrahepatic or extrahepatic cholestatic liver disease. Chronic is defined as greater than 6 weeks of symptom duration. Pruritus severity is based on the peak pruritus numerical rating score of ≥ 4 (moderate severity).
  • Documentation of a personally signed and dated informed consent indicating that the subject or their legally acceptable representative has been informed of all pertinent aspects of the trial.
  • Willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, effective contraception use, and other trial procedures.

Exclusion Criteria:

  • Male and/or female subjects under 18 years of age.
  • Pruritus due to a primary inflammatory skin dermatosis or other forms of psychogenic pruritus utilizing skin biopsies as needed.
  • Pregnant females
  • History of intrahepatic cholestasis of pregnancy
  • Any form of chronic hepatic pruritus associated with underlying malignancy
  • Liver transplant recipients
  • Allergy to dupilumab or its ingredients
  • Inability to provide informed consent
  • Concomitant use of selective opioid antagonists
  • Subjects with severe asthma (requiring high-dose inhaled or systemic corticosteroids) will be excluded from the study.
  • Patients with known helminth infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dupilumab
Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.
Drug: Dupilumab 300Mg Solution for Injection
Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.
Other Names:
  • Dupixent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Peak Pruritus Numerical Rating Score (PRNS)
Time Frame: Baseline; 20 weeks
Pruritus severity is measured using the peak PNRS assessed as a single, self-completed item that assesses the intensity of peak (worst) pruritus during the past 24 hours using the query: "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?". Measured before and after treatment. Scores range from 0 to 10 with higher scores indicating a worse outcome.
Baseline; 20 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Weekly Average Peak Pruritus Numerical Rating Score (PRNS) ≥3 From Baseline
Time Frame: Baseline; week 6,12,18
Pruritus severity is measured using the peak PNRS assessed as a single, self-completed item that assesses the intensity of peak (worst) pruritus during the past 24 hours using the query: "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?". Scores range from 0 to 10 with higher scores indicating a worse outcome.
Baseline; week 6,12,18
Verbal Rating Scale (VRS) Score
Time Frame: Baseline; week 12,18
The number of subjects who rated their intensity of pruritus as 0=none, 1=mild, 2-moderate, 3=severe. The verbal rating scale measures the intensity of pruritus. Subjects are asked to rate their pruritus intensity as 0=none; 1= mild; 2=moderate; and 3=severe/intense. Scores range from 0 to 3, with higher scores indicating a worse outcome.
Baseline; week 12,18
Change in Chronic Liver Disease Questionnaire (CLDQ) Score
Time Frame: Baseline; 18 Weeks
This is a validated 29 question quality life instrument for patients with chronic liver disease evaluating systemic symptoms, fatigue, physical activity, emotional function, and worry. Subjects are asked to respond to each question using the following scale: 6=all of the time; 5=most of the time; 4=a good bit of the time; 3=some of the time; 2=a little of the time; 1=hardly any of the time; and 0=none of the time. Total scores range from 0 to 174 with lower scores indicating better health-related quality of life.
Baseline; 18 Weeks
Change in 5D Pruritus Score
Time Frame: Baseline; 18 Weeks
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, with higher scores indicating a worse outcome.
Baseline; 18 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jason Sluzevich, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 6, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 5, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-002757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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