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NCT05569759 · ClinicalTrials.gov registry record · Phase 2
A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)
A Phase 2 study, sponsored by Kezar Life Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT05569759: Completed Phase 2 study, sponsored by Kezar Life Sciences.
NCT05569759 is a Phase 2 study that has completed, run by Kezar Life Sciences. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05569759, a Phase 2 study, has completed, sponsored by Kezar Life Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
This was a Phase 2a, multi-center, placebo-controlled study in which patients with autoimmune hepatitis received zetomipzomib or placebo in addition to standard-of-care for 24 weeks; an optional open-label extension period allowed participants to receive zetomipzomib (KZR-616) for an additional 24 weeks of treatment.
Primary Outcome
The number of patients who achieve complete biochemical response (CR), defined as normal ALT, AST, and IgG values (if IgG level is elevated at Baseline) with glucocorticoid dose not higher than starting dose (at Baseline), by Week 24 of the Double-Blind Treatment Period. Analyses were also conducted at Week 12, Week 16, and Week 20.
Interventions
- DRUG placebo
- DRUG zetomipzomib
- DRUG zetomipzomib in open-label extension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-05-23 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 2 |
What the finished NCT05569759 record still lists
NCT05569759 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT05569759 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05569759 about?
NCT05569759 is a clinical study titled "A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)". This was a Phase 2a, multi-center, placebo-controlled study in which patients with autoimmune hepatitis received zetomipzomib or placebo in addition to standard-of-care for 24 weeks; an optional open-label extension period allowed participants to receive zetomipzomib (KZR-616) for an additional 24 w...
What is the current status of trial NCT05569759?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2023-05-23. Estimated completion is 2025-04-30.
What interventions are being tested in trial NCT05569759?
The interventions under investigation include: placebo (DRUG), zetomipzomib (DRUG), zetomipzomib in open-label extension (DRUG).
Who is sponsoring clinical trial NCT05569759?
This trial is sponsored by Kezar Life Sciences, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05569759's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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