Trial · NCT05569759
A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)
NCT05569759, Phase 2, Completed, Kezar Life Sciences, Inc.; results first posted 2026-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA). Trials, record NCT05569759. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05569759
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA)
- NCT number
- NCT05569759
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Kezar Life Sciences, Inc.
- Conditions
- Autoimmune Hepatitis
- Interventions
- zetomipzomib, placebo, zetomipzomib in open-label extension
- First posted
- 2022-10-06
- Last updated
- 2026-01-13
- Results first posted
- 2026-01-13
- Limitations and caveats
- Limitations of this study include its small sample size, unpowered design, and a predominantly white study population, which may limit generalizability.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients Who Achieved Complete Biochemical Response | Week 12, Week 16, Week 20, and Week 24 | 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. |
| Primary | The Safety and Tolerability of Zetomipzomib | Baseline through end of study visit (DBTP, Week 28 and OLE, Up to Week 24) | Proportion of participants who experience AEs (adverse events) and SAEs (serious adverse events) during the double-blind treatment period (DBTP) and the open-label extension (OLE). |
| Primary | Proportion of Participants Experiencing a Disease Flare Among the Participants Who Achieved a CR During the Double-blind Treatment Period | Start of open-label extension (OLE) period through End of Study (EOS) up to OLE Week 25 | Proportion of participants experiencing a disease flare among the participants who achieved a complete biochemical response (CR) during the double-blind treatment period. |
| Secondary | Alanine Aminotransferase (ALT) | Weeks 12, 16, 20, and 24 | Changes from baseline in alanine aminotransferase (ALT) during the double-blind treatment period. |
| Secondary | Partial Response | Weeks 12, 16, 20, and 24 | Proportion of participants who achieved a partial response (PR) during the double-blind treatment period of the study. |
| Secondary | Time to Complete Response | Baseline through Week 24 | Time to complete response (CR), defined as the duration from first dose of study drug (zetomipzomib or placebo) to first CR, during the double-blind treatment period was measured using the Kaplan-Meier method. Due to the small sample size, not enough events of participants achieving CR were observed to provide Kaplan-Meier estimates for the 25th percentile, median, and 75th percentile time to CR. |
| Secondary | Disease Flare After CR | Week 24 | Proportion of participants who experienced a disease flare after complete response (CR) during the double-blind treatment period. |
| Secondary | Treatment Failures | Week 24 | Proportion of participants who were considered treatment failures, defined as ALT or AST level worsened ≥2 times that of the Baseline value that is sustained for ≥1 week as verified via repeat laboratory assessments, despite compliance with standard of care (ie, with regard to inclusion criteria) or protocol-defined therapy or a glucocorticoid dose is increased above the Baseline dose, it may be considered a treatment failure unless attributed to an adverse event not relating to AIH, during the double-blind treatment period. |
| Secondary | Complete Response With Glucocorticoid Taper to ≤10 mg | Weeks 12, 16, 20, and 24 | Percentage of participants who achieved complete response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period. |
| Secondary | Complete Response With Glucocorticoid Taper to ≤5 mg | Weeks 12, 16, 20, and 24 | Percentage of participants who achieved complete response and glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Patients Who Achieved Complete Biochemical Response | Week 12, Week 16, Week 20, and Week 24 | The Intent to Treat (ITT) Set included all randomized participants (N=24). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | The Safety and Tolerability of Zetomipzomib | Baseline through end of study visit (DBTP, Week 28 and OLE, Up to Week 24) | The Safety Set (N=23) includes all participants who received at least one dose of IMP and were analyzed as randomized to treatment. | participants | NUMBER |
| PRIMARY | Proportion of Participants Experiencing a Disease Flare Among the Participants Who Achieved a CR During the Double-blind Treatment Period | Start of open-label extension (OLE) period through End of Study (EOS) up to OLE Week 25 | Participants who enrolled in the optional open-label extension following their completion of the double-blind treatment period of the study and achieved a complete response during the double-blind treatment period. | participants | NUMBER |
| SECONDARY | Alanine Aminotransferase (ALT) | Weeks 12, 16, 20, and 24 | The Intent to Treat (ITT) Set included all randomized participants (N=24). | U/L | MEAN |
| SECONDARY | Partial Response | Weeks 12, 16, 20, and 24 | The Intent to Treat (ITT) Set included all randomized participants (N=24). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Complete Response | Baseline through Week 24 | The Intent to Treat (ITT) Set included all randomized participants (N=24). | weeks | MEDIAN |
| SECONDARY | Disease Flare After CR | Week 24 | The Intent to Treat (ITT) Set included all randomized participants (N=24). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Failures | Week 24 | The Intent to Treat (ITT) Set included all randomized participants (N=24). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Complete Response With Glucocorticoid Taper to ≤10 mg | Weeks 12, 16, 20, and 24 | The Intent to Treat (ITT) Set included all randomized participants (N=24). | percent of participants | NUMBER |
| SECONDARY | Complete Response With Glucocorticoid Taper to ≤5 mg | Weeks 12, 16, 20, and 24 | The Intent to Treat (ITT) Set included all randomized participants (N=24). | percent of participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group110
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Patients Who Achieved Complete Biochemical Response | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Week 12 | 6 | Participants | |
| Patients Who Achieved Complete Biochemical Response | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | Week 12 | 3 | Participants | |
| Patients Who Achieved Complete Biochemical Response | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Week 16 | 7 | Participants | |
| Patients Who Achieved Complete Biochemical Response | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | Week 16 | 3 | Participants | |
| Patients Who Achieved Complete Biochemical Response | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Week 20 | 8 | Participants | |
| Patients Who Achieved Complete Biochemical Response | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | Week 20 | 3 | Participants | |
| Patients Who Achieved Complete Biochemical Response | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Week 24 | 8 | Participants | |
| Patients Who Achieved Complete Biochemical Response | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | Week 24 | 3 | Participants | |
| The Safety and Tolerability of Zetomipzomib | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Serious adverse events | 2 | participants | |
| The Safety and Tolerability of Zetomipzomib | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | Serious adverse events | 1 | participants |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Treatment Period | STARTED | Zetomipzomib + Standard-of-care (Glucocorticoids) | 16 | |
| Double Blind Treatment Period | STARTED | Placebo + Standard-of-care (Glucocorticoids) | 8 | |
| Double Blind Treatment Period | COMPLETED | Zetomipzomib + Standard-of-care (Glucocorticoids) | 13 | |
| Double Blind Treatment Period | COMPLETED | Placebo + Standard-of-care (Glucocorticoids) | 7 | |
| Double Blind Treatment Period | NOT COMPLETED | Zetomipzomib + Standard-of-care (Glucocorticoids) | 3 | |
| Double Blind Treatment Period | NOT COMPLETED | Placebo + Standard-of-care (Glucocorticoids) | 1 | |
| Optional Open-Label Extension | STARTED | Zetomipzomib + Standard-of-care (Glucocorticoids) | 9 | |
| Optional Open-Label Extension | STARTED | Placebo + Standard-of-care (Glucocorticoids) | 5 | |
| Optional Open-Label Extension | COMPLETED | Zetomipzomib + Standard-of-care (Glucocorticoids) | 4 | |
| Optional Open-Label Extension | COMPLETED | Placebo + Standard-of-care (Glucocorticoids) | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events724
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | 0 | 16 | 0 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | 0 | 7 | 0 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP) | 1 | 9 | 1 |
| other | Increased tendency to bruise | Blood and lymphatic system disorders | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP) | 0 | 5 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | 0 | 16 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | 1 | 7 | 1 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP) | 0 | 9 | 0 |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP) | 0 | 5 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | 1 | 16 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | 0 | 7 | 0 |
1 to 10 of 724Source ClinicalTrials.gov
See all 724 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | 0 | 16 |
| Total, all-cause mortality | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | 0 | 7 |
| Total, all-cause mortality | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP) | 0 | 9 |
| Total, all-cause mortality | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP) | 0 | 5 |
| Total, other adverse events | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | 16 | 16 |
| Total, other adverse events | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | 7 | 7 |
| Total, other adverse events | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP) | 9 | 9 |
| Total, other adverse events | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP) | 5 | 5 |
| Total, serious adverse events | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | 2 | 16 |
| Total, serious adverse events | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | 1 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) vs Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids): Disease Flare After CR | Trial comparisons |
Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP) vs Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP): Proportion of Participants Experiencing a Disease Flare Among the Participants Who Achieved a CR During the Double-blind Treatment Period | Trial comparisons |
| Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) vs Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids): Treatment Failures | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05569759
GET https://conductscience.org/api/trials/v1/NCT05569759/results?page=2