Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal

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