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Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

Primary Purpose

Pruritus

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dupilumab 300Mg Solution for Injection
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pruritus focused on measuring Dupilumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 has been informed of all pertinent aspects of the trial.
  • Willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, 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

Sites / Locations

  • Mayo Clinic FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dupilumab

Arm Description

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

Outcomes

Primary Outcome Measures

Peak Pruritus Numerical Rating Score (PRNS)
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.

Secondary Outcome Measures

Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥3 from baseline.
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.
Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥4 from baseline.
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.
Verbal rating scale (VRS)
Mean change of pruritus as measured 0=none; 1= mild; 2=moderate; and 3=severe/intense.

Full Information

First Posted
February 3, 2020
Last Updated
October 16, 2023
Sponsor
Mayo Clinic
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04256759
Brief Title
Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Official Title
Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: an Open-Label, Single-Arm, Exploratory Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Regeneron Pharmaceuticals

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pruritus
Keywords
Dupilumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dupilumab
Arm Type
Experimental
Arm Description
Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.
Intervention Type
Drug
Intervention Name(s)
Dupilumab 300Mg Solution for Injection
Other Intervention Name(s)
Dupixent
Intervention Description
Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.
Primary Outcome Measure Information:
Title
Peak Pruritus Numerical Rating Score (PRNS)
Description
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.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥3 from baseline.
Description
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.
Time Frame
This will be assessed at week 6,12,18
Title
Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥4 from baseline.
Description
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.
Time Frame
This will be assessed at week 6,12,18
Title
Verbal rating scale (VRS)
Description
Mean change of pruritus as measured 0=none; 1= mild; 2=moderate; and 3=severe/intense.
Time Frame
This will be assessed at week 6,12,18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 has been informed of all pertinent aspects of the trial. Willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel A Pung Page
Phone
904-953-8513
Email
White.Rachel2@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Sluzevich, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

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