NCT04256759

Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: an Open-Label, Single-Arm, Exploratory Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Pruritus

Interventions

Type	Name	Description
DRUG	Dupilumab 300Mg Solution for Injection	Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.

Timeline

• Start date: 2020-09-01
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2020-02-05
• Last updated: 2025-11-21
• Results posted: 2025-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study