Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

Mayo Clinic

Status and phase

Completed

Phase 2

Conditions

Pruritus

Treatments

Drug: Dupilumab 300Mg Solution for Injection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04256759

19-002757

Details and patient eligibility

About

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

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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