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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up this will be assessed at week 6,12,18
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 or older with long-term severe itching due to liver disease.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak Pruritus Numerical Rating Score (PRNS)
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,772 Total Patients Enrolled
Regeneron PharmaceuticalsIndustry Sponsor
615 Previous Clinical Trials
379,835 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Dupilumab 300Mg Solution for Injection?

"As it is a Phase 2 trial, our team at Power assigned Dupilumab 300Mg Solution for Injection a safety score of 2; evidence has been found to support its security but none affirmatively demonstrating that the treatment is effective."

Answered by AI

What medical condition does Dupilumab 300Mg Solution for Injection typically ameliorate?

"Dupilumab 300Mg Solution for Injection is typically used to address dermatitis, atopic. However, it has also been known to prove efficacious in treating conditions such as corticosteroid failure, eosinophilia and asthma."

Answered by AI

Has there been any prior research undertaken for this medical investigation?

"Since 2015, Dupilumab 300Mg Solution for Injection has been the focus of numerous clinical studies. Sanofi was the primary sponsor of its first trial in 2015 which involved 880 patients and subsequently led to Phase 3 drug approval being granted. Currently, there are 49 ongoing trials taking place across 436 cities and 43 nations worldwide."

Answered by AI

Are there any historical records of the efficacy of Dupilumab 300Mg Solution for Injection in clinical trials?

"Presently, there are 49 separate clinical trials examining the efficacy of Dupilumab 300Mg Solution for Injection with 13 in Phase 3. California's Palo Alto is home to a majority of these experiments; however, Dupilumab 300Mg Solution for Injection is being tested across 2,602 medical centres worldwide."

Answered by AI

Are there still opportunities to participate in this research initiative?

"That is correct. According to clinicaltrials.gov, this trial was published on September 1st 2020 and has since been updated for the last time November 17th 2021. The study needs a dozen patients from one medical site in order to be successful."

Answered by AI

How many individuals are partaking in this experiment?

"Indeed, clinicaltrials.gov shows that this experiment is actively scouting for patients. It was initially made available on September 1st 2020 and updated as recently as November 17th 2021. A total of 12 people need to be recruited from a single research site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus
Jason Sluzevich MD 2020. "Dupilumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04256759.
~3 spots leftby Apr 2025
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