Clinical trial NCT04256759: Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Official title: Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus: an Open-Label, Single-Arm, Exploratory Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pruritus
Keywords: Dupilumab
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2020-02-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Peak Pruritus Numerical Rating Score (PRNS)
timeFrame: 20 weeks
Secondary outcomes:
measure: Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥3 from baseline.
timeFrame: This will be assessed at week 6,12,18
measure: Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥4 from baseline.
timeFrame: This will be assessed at week 6,12,18
measure: Verbal rating scale (VRS)
timeFrame: This will be assessed at week 6,12,18
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Jason Sluzevich, MD
role: PRINCIPAL_INVESTIGATOR
References: