Nemolizumab for Cholestatic Liver Disease

RE
Overseen ByReagan E. Dukes, MHA
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to investigate the efficacy of nemolizumab in the treatment of adults with moderate to severe chronic hepatic pruritus.

Who Is on the Research Team?

JS

Jason Sluzevich, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults who have moderate to severe long-lasting itching caused by liver diseases like primary biliary cholangitis or primary sclerosing cholangitis. People with other major health issues or certain conditions may not be able to join.

Inclusion Criteria

I have moderate or severe itching, with a score of 5 or higher.
I have had ongoing itching for at least 6 months.
Willingness and ability to comply with scheduled clinic visits, physical exams, laboratory tests, questionnaires, effective contraception use, and other trial procedures
See 2 more

Exclusion Criteria

I have ongoing liver-related itching caused by my cancer.
ALT or AST greater than 3 times the upper limit of normal or total bilirubin greater than 2 times the upper normal limit
I am unable to give informed consent for my treatment.
See 9 more

What Are the Treatments Tested in This Trial?

Interventions

  • Nemolizumab-ilto

Trial Overview

The study is testing nemolizumab, a new medication, to see if it can help reduce moderate to severe chronic itching in people with specific liver diseases. Participants will receive the drug and its effects will be closely monitored.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Nemolizumab-iltoExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+