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Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04256759
Collaborator
Regeneron Pharmaceuticals (Industry)
12
Enrollment
1
Location
1
Arm
39
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Dupilumab 300Mg Solution for Injection
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: an Open-Label, Single-Arm, Exploratory Study
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Peak Pruritus Numerical Rating Score (PRNS) [20 weeks]

      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

    1. Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥3 from baseline. [This will be assessed at week 6,12,18]

      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.

    2. Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥4 from baseline. [This will be assessed at week 6,12,18]

      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.

    3. Verbal rating scale (VRS) [This will be assessed at week 6,12,18]

      Mean change of pruritus as measured 0=none; 1= mild; 2=moderate; and 3=severe/intense.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Florida Jacksonville Florida United States 32224

    Sponsors and Collaborators

    • Mayo Clinic
    • Regeneron Pharmaceuticals

    Investigators

    • Principal Investigator: Jason Sluzevich, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Jason Sluzevich MD, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT04256759
    Other Study ID Numbers:
    • 19-002757
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Nov 18, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Jason Sluzevich MD, Principal Investigator, Mayo Clinic
    Dupilumab
    Additional relevant MeSH terms:
    Pruritus

    Study Results

    No Results Posted as of Nov 18, 2021