Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

  • STATUS
    Recruiting
  • End date
    Dec 26, 2023
  • participants needed
    12
  • sponsor
    Mayo Clinic
Updated on 26 November 2021
chronic pruritus

Summary

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

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.

Details
Condition Dermatosis, Congenital Skin Diseases, Skin Conditions, Pruritus
Treatment Dupilumab 300Mg Solution for Injection
Clinical Study IdentifierNCT04256759
SponsorMayo Clinic
Last Modified on26 November 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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