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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
Must be aged ≥18 years
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

Study 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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

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.

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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

Frequently Asked Questions

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

Are enrollment opportunities still available for this clinical experiment?

"Based on the clinicaltrials.gov entry, this trial is presently trying to locate participants. The record was initially made available on January 1st 2023 and was last updated five days later."

Answered by AI

How many individuals are involved in this experiment?

"Affirmative. The clinicaltrials.gov website confirms that this trial is actively seeking volunteers, first announced on January 1st 2023 and most recently updated on May 5th of the same year. A total of 24 patients must be recruited from a single location for this study to proceed."

Answered by AI

What primary outcomes is this trial hoping to accomplish?

"This trial is designed to assess the efficacy of zetomipzomib over a timeline extending through 28-weeks. As secondary objectives, researchers hope to quantify time taken until partial remission (PR), percentage of participants that reach PR status, and timeframe for complete remission (CR)."

Answered by AI

Did the FDA sanction zetomibzomib combined with glucocorticoids as a therapy?

"The safety of zetomibzomib + standard-of-care (glucocorticoids) was assessed with a score of 2, since there is early evidence supporting its security but none suggesting it's effectiveness."

Answered by AI
~6 spots leftby Sep 2024