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Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

24 Participants Needed

Zetomipzomib for Autoimmune Hepatitis

Recruiting at 23 trial locations

Overseen ByLi Long, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kezar Life Sciences, Inc.

Must be taking: Glucocorticoids

Must not be taking: Immunomodulators

Disqualifiers: Primary biliary sclerosis, Uncontrolled diseases, Active infection, others

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial tests zetomipzomib, a new medication, in patients with autoimmune hepatitis who haven't responded well to standard treatments. The drug is given as an injection to help calm the immune system and reduce liver damage.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you must be willing to taper glucocorticoid therapy. If you are on immunomodulating treatments for other autoimmune diseases, you must follow a washout period (time without taking those medications) before joining the study.

How does the drug Zetomipzomib differ from other treatments for autoimmune hepatitis?

Zetomipzomib is unique because it is being studied specifically for autoimmune hepatitis, whereas current standard treatments typically involve steroids like prednisone or prednisolone combined with azathioprine. This drug may offer a novel approach by potentially targeting different pathways involved in the disease.¹ ² ³ ⁴ ⁵

Research Team

Ethan Weinberg, MD

Principal Investigator

University of Pennsylvania

Craig Lammert, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults over 18 with autoimmune hepatitis (AIH) showing active disease or flare-ups despite ongoing treatment. Participants must have certain liver enzyme levels and a recent biopsy confirming AIH. They should be in early-stage liver impairment and willing to adjust their steroid therapy.

Inclusion Criteria

I am 18 years old or older.

Must have a clinical diagnosis of AIH and signs of active disease despite standard-of-care therapy for ≥3 months or disease flare after experiencing complete remission induced by standard-of-care treatment, including: Screening ALT values that are 1.25 to 10 times the upper limit of the normal range (ULN), Liver biopsy results with Ishak score (modified HAI) ≥5/18 indicating active AIH, from a biopsy performed at Screening, or within 6 months prior to Screening, Mild or no hepatic impairment (Child Pugh category A), Must be willing to use and taper glucocorticoid therapy, Must be willing to use effective contraception

Exclusion Criteria

Have a concomitant diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, IgG 4 related cholangitis, drug related AIH (at Screening) or a history of drug-related AIH, Have clinical evidence of significant unstable or uncontrolled diseases other than the disease under study, Are receiving oral or injectable immunomodulating treatment for any other autoimmune disease prior to enrollment in the study. Patients who have been using such treatments must follow the specified washout periods, Have an active infection (eg, acute hepatitis E, cytomegalovirus, or Epstein-Barr virus) requiring systemic therapy with antibiotic, antiviral, or antifungal treatment, or has had any febrile illness within 7 days prior to Day -1, Have a history of thyroiditis, celiac disease, or other autoimmune disorder known to be associated with transaminitis, Have liver cirrhosis with significant impairment of liver function (Child Pugh category B or C) or have decompensated cirrhosis, Patients with histology confirmed coincident non-alcoholic steatohepatitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zetomipzomib or placebo weekly for 24 weeks in addition to standard-of-care treatment

24 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Open-label extension

Eligible participants receive zetomipzomib for an additional 24 weeks

24 weeks

Weekly visits (in-person)

Treatment Details

Interventions

Placebo
Zetomipzomib

Trial OverviewThe study tests Zetomipzomib, an investigational drug, against a placebo alongside standard care for AIH patients for 24 weeks. There's also an optional extension where everyone can get Zetomipzomib for another 24 weeks.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: zetomipzomib + standard-of-care (glucocorticoids)Experimental Treatment1 Intervention

Initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period.

Group II: zetomipzomib + standard-of care (glucocorticoids) open-label extension periodExperimental Treatment1 Intervention

Initial 30 mg dose of zetomipzomib at the open-label extension (OLE) Week 1 visit, followed by weekly doses of 60 mg of zetomipzomib, for a total of 24 additional weeks of treatment.

Group III: placebo + standard-of-care (glucocorticoids)Placebo Group1 Intervention

Initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period.