Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

NCT04256759 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 19-002757
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pruritus

Keywords

Dupilumab

Outcome Measures

Primary Outcomes (1)

• Change in Peak Pruritus Numerical Rating Score (PRNS)

  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 Outcomes (4)

• Change in Weekly Average Peak Pruritus Numerical Rating Score (PRNS) ≥3 From Baseline

  Baseline; week 6,12,18

• Verbal Rating Scale (VRS) Score

  Baseline; week 12,18

• Change in Chronic Liver Disease Questionnaire (CLDQ) Score

  Baseline; 18 Weeks

• Change in 5D Pruritus Score

  Baseline; 18 Weeks

Study Arms (1)

Dupilumab

EXPERIMENTAL

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

Drug: Dupilumab 300Mg Solution for Injection

Interventions

Dupilumab 300Mg Solution for Injection DRUG

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

Also known as: Dupixent

Dupilumab

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pruritus

Interventions

dupilumab; Solutions; Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Jason Sluzevich, M.D.
• Organization: Mayo Clinic

sluzevich.jason@mayo.edu

904-953-6192

Study Officials

• Jason Sluzevich, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: February 3, 2020
• First Posted: February 5, 2020
• Study Start: September 1, 2020
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: November 21, 2025
• Results First Posted: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)