Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

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

Detailed Description
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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.

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

Conditions
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Pruritus

Intervention / Treatment
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* Drug: Dupilumab 300Mg Solution for Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dupilumab<br>Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks. | Drug: Dupilumab 300Mg Solution for Injection<br>* Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.<br>* Other names: Dupixent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Pruritus Numerical Rating Score (PRNS) | Scale of 0 to 10, with 0 being 'no itch 'and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Measured before and after treatment. | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥3 from baseline. | Scale of 0 to 10, with 0 being 'no itch 'and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Measured before and after treatment. | This will be assessed at week 6,12,18 | 
| Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥4 from baseline. | Scale of 0 to 10, with 0 being 'no itch 'and 10 being 'worst itch imaginable', how would you rate your itch at the worst moment during the previous 24 hours?. Measured before and after treatment. | This will be assessed at week 6,12,18 | 
| Verbal rating scale (VRS) | Mean change of pruritus as measured 0=none; 1= mild; 2=moderate; and 3=severe/intense. | This will be assessed at week 6,12,18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dupilumab