Overview
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.
Eligibility
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