Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04256759
• Other study ID #: 19-002757
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2020
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Rachel A Pung Page
• Phone: 904-953-8513
• Email: White.Rachel2[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pruritus

Intervention

Drug:
• Dupilumab 300Mg Solution for Injection
Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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