Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus (NCT04256759) | Clinical Trial Compass
CompletedPhase 2
Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
United States9 participantsStarted 2020-09-01
Plain-language summary
To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in Peak Pruritus Numerical Rating Score (PRNS)