Skip to main content
OpenTrials
Completed

NCT Number: NCT04256759

Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pruritus Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dupilumab 300Mg Solution for Injection

Drug

Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.

Other names: Dupixent

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2020
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.