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Monoclonal Antibodies

Dupilumab for Severe Chronic Itching

Phase 2

Recruiting

Led By Jason Sluzevich, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

Be older than 18 years old

Must not have

Pruritus due to a primary inflammatory skin dermatosis or other forms of psychogenic pruritus utilizing skin biopsies as needed.

Any form of chronic hepatic pruritus associated with underlying malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this will be assessed at week 6,12,18

Awards & highlights

Summary

This trial is testing if a medication called dupilumab can help treat moderate to severe chronic itching of the skin.

Who is the study for?

This trial is for adults over 18 with moderate to severe itching due to liver disease lasting more than 6 weeks. Participants must be able to follow the trial procedures and not have a history of certain conditions like liver malignancy, past liver transplants, or specific types of pruritus. Pregnant individuals and those with severe asthma or allergies to dupilumab are excluded.

What is being tested?

The trial is testing Dupilumab, an injectable medication, for its effectiveness in treating chronic itching associated with liver disease. The goal is to see if this drug can provide relief from persistent and intense itching.

What are the potential side effects?

Dupilumab may cause side effects such as allergic reactions at the injection site, eye inflammation or irritation, cold sores in your mouth or on your lips, and potentially other immune system-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with long-term severe itching due to liver disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have itching due to skin inflammation or a psychological condition.

Select...

I experience chronic itching due to liver-related cancer.

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I have received a liver transplant.

Select...

I am under 18 years old.

Select...

I have a known worm infection.

Select...

I do not have severe asthma that needs high-dose steroids.

Select...

I am currently taking selective opioid antagonists.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this will be assessed at week 6,12,18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this will be assessed at week 6,12,18

This trial's timeline: 3 weeks for screening, Varies for treatment, and this will be assessed at week 6,12,18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Peak Pruritus Numerical Rating Score (PRNS)

Secondary study objectives

Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥3 from baseline.

Improvement in weekly average Peak Pruritus Numerical Rating Score (PRNS) ≥4 from baseline.

Verbal rating scale (VRS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: DupilumabExperimental Treatment1 Intervention

Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,308 Previous Clinical Trials

2,962,417 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

655 Previous Clinical Trials

385,255 Total Patients Enrolled

Jason Sluzevich, MDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital Jacksonville

Yale University School Of Medicine (Medical School)

University Hosp, Inc (Residency)

1 Previous Clinical Trials

12 Total Patients Enrolled

Media Library

Dupilumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04256759 — Phase 2

Itching Research Study Groups: Dupilumab

Itching Clinical Trial 2023: Dupilumab Highlights & Side Effects. Trial Name: NCT04256759 — Phase 2

Dupilumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04256759 — Phase 2

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