Phase 2
N=9
Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Pruritus
Bottom Line
View on ClinicalTrials.gov: NCT04256759 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Change in Peak Pruritus Numerical Rating Score (PRNS) — -3.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dupilumab 300Mg Solution for Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak Pruritus Numerical Rating Score (PRNS) |
-3.1 | — |
| SECONDARY Change in Weekly Average Peak Pruritus Numerical Rating Score (PRNS) ≥3 From Baseline |
-3.2; -3.5; -4.1 | — |
| SECONDARY Verbal Rating Scale (VRS) Score |
0; 0; 4; 5; 1; 4 | 0.018 sig |
| SECONDARY Change in Chronic Liver Disease Questionnaire (CLDQ) Score |
25.7 | 0.13 |
| SECONDARY Change in 5D Pruritus Score |
-7.3 | 0.006 sig |
Summary
To investigate the potential efficacy of dupilumab in the treatment of moderate to severe chronic hepatic pruritus.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT04256759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.