What side effects are associated with this type of intervention?

Common treatments for autoimmune hepatitis include corticosteroids like prednisone and immunosuppressants such as azathioprine. Corticosteroids can cause side effects like weight gain, diabetes, osteoporosis, and increased susceptibility to infections. Azathioprine may lead to myelosuppression, hepatotoxicity, gastrointestinal disturbances, and an increased risk of infections and certain cancers. Similar to these treatments, Zetomipzomib (KZR-616) aims to reduce inflammation and autoimmunity but through selective inhibition of the immunoproteasome. While specific side effects of Zetomipzomib are not detailed, it is likely to share some common immunosuppressive-related risks such as increased infection susceptibility and potential liver toxicity.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for autoimmune hepatitis that work through selective inhibition of the immunoproteasome like Zetomipzomib (KZR-616). Current standard treatments for autoimmune hepatitis typically include corticosteroids such as prednisone and immunosuppressive drugs like azathioprine, which work by broadly suppressing the immune system to reduce inflammation. These treatments aim to control the autoimmune response and prevent liver damage.

What other types of research exist?

Promising novel alternatives to Zetomipzomib (KZR-616) for Autoimmune Hepatitis patients include: 1) Eltrombopag, a thrombopoietin receptor agonist, which has shown efficacy in immune thrombocytopenia and may help in managing AIH by modulating immune responses. 2) Filgotinib, a selective Janus kinase 1 (JAK1) inhibitor, which has demonstrated efficacy in psoriatic arthritis and could potentially reduce inflammation in AIH. 3) Obinutuzumab, a monoclonal antibody targeting CD20, used in follicular lymphoma, which may offer benefits by depleting B cells involved in autoimmunity.

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Zetomipzomib for Autoimmune Hepatitis

Phase 2

Recruiting

Led By Craig Lammert, MD

Research Sponsored by Kezar Life Sciences, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of open-label extension (ole) period through end of study (eos) at ole week 29

Awards & highlights

Summary

This trial tests a new drug to treat autoimmune hepatitis. Patients receive either drug or placebo in addition to standard care for 24 weeks.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects of Zetomipzomib may include reactions at the injection site, gastrointestinal issues like nausea or diarrhea, blood cell count changes, increased risk of infections, and possible liver-related complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of open-label extension (ole) period through end of study (eos) at ole week 29

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of open-label extension (ole) period through end of study (eos) at ole week 29

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of open-label extension (ole) period through end of study (eos) at ole week 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the efficacy of zetomipzomib

To evaluate the efficacy of zetomipzomib during the open-label extension period

To evaluate the safety and tolerability of zetomipzomib

Secondary outcome measures

Alanine aminotransferase (ALT)

Partial Remission

Time to complete remission

+1 more

Other outcome measures

Plasma

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: 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 II: zetomibzomib + 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 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.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autoimmune Hepatitis (AIH) include corticosteroids like prednisone and immunosuppressants such as azathioprine. Corticosteroids work by broadly suppressing the immune system, reducing inflammation and preventing the immune system from attacking liver cells. Azathioprine inhibits the synthesis of DNA, RNA, and proteins, thereby reducing the proliferation of immune cells that contribute to liver inflammation. These treatments are crucial for AIH patients as they help control the autoimmune response and prevent liver damage. Zetomipzomib (KZR-616), currently under study, selectively inhibits the immunoproteasome, which plays a key role in immune cell function and inflammation. By targeting the immunoproteasome, Zetomipzomib aims to reduce inflammation and autoimmunity more precisely, potentially offering a more targeted and effective treatment option for AIH patients.

Bortezomib in autoimmune hemolytic anemia and beyond.B Cell Therapy in Systemic Lupus Erythematosus: From Rationale to Clinical Practice.On the role of the immunoproteasome in transplant rejection.

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Who is running the clinical trial?

Kezar Life Sciences, Inc.Lead Sponsor

6 Previous Clinical Trials

616 Total Patients Enrolled

Craig Lammert, MDPrincipal InvestigatorIndiana University

Paul MartinPrincipal InvestigatorUniversity of Miami

3 Previous Clinical Trials

166 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05569759 — Phase 2

Autoimmune Hepatitis Research Study Groups: zetomipzomib + standard-of care (glucocorticoids) open-label extension period, zetomibzomib + standard-of-care (glucocorticoids), placebo + standard-of-care (glucocorticoids)

Autoimmune Hepatitis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05569759 — Phase 2

Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05569759 — Phase 2

~2 spots leftby Sep 2024

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