A Phase 2 interventional study of zetomipzomib and placebo in Autoimmune Hepatitis, sponsored by Kezar Life Sciences, Inc.. Completed at 24 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Kezar Life Sciences, Inc. · Phase 2, Interventional, and Treatment
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.
This was a Phase 2a, multi-center, randomized, double-blind, placebo-controlled study with an open-label extension to evaluate safety, tolerability, and efficacy of zetomipzomib in patients with autoimmune hepatitis (AIH) who have not benefited from standard-of-care treatment, had an incomplete response to ≥3 months of standard-of-care treatment, or had a disease flare after standard of care.
Zetomipzomib or placebo were administered weekly for a 24-week treatment period in addition to standard-of-care (glucocorticoids), followed by a 4-week off-treatment safety follow-up period. Zetomipzomib and placebo was administered subcutaneously (SC) once weekly.
At the end of the 24-week treatment period, eligible participants from both the zetomipzomib- and placebo-treated arms who completed the double-blind treatment period could enroll in the open-label extension period to receive up to an additional 24 weeks of treatment with zetomipzomib.
82 studies on the registry are indexed under Hepatitis, Autoimmune; 24 are open to participants now.
This study's enrollment of 24 is below the median of 48 across 42 interventional studies indexed under Hepatitis, Autoimmune.
Browse Hepatitis, Autoimmune studies →Kezar Life Sciences, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria for the Double-blind Treatment Period:
Must be aged ≥18 years.
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:
Key Exclusion Criteria for the Double-blind Treatment Period:
Key Inclusion Criteria for the Open-label Extension Period:
Same as Double-blind Treatment Period inclusion criteria, except the following modifications:
Key Exclusion Criteria for the Open-label Extension Period:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period.
Drug: zetomipzomib
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.
Drug: placebo
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 up to a total of 24 additional weeks of treatment.
Drug: zetomipzomib in open-label extension
Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
Also known as: KZR-616
Subcutaneous injection of placebo
Also known as: sterile water for injection
Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
Also known as: KZR-616
Patients Who Achieved Complete Biochemical Response
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.
Time frame: Week 12, Week 16, Week 20, and Week 24
The Safety and Tolerability of Zetomipzomib
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).
Time frame: Baseline through end of study visit (DBTP, Week 28 and OLE, Up to Week 24)
Proportion of Participants Experiencing a Disease Flare Among the Participants Who Achieved a CR During the Double-blind Treatment Period
Proportion of participants experiencing a disease flare among the participants who achieved a complete biochemical response (CR) during the double-blind treatment period.
Time frame: Start of open-label extension (OLE) period through End of Study (EOS) up to OLE Week 25
Alanine Aminotransferase (ALT)
Changes from baseline in alanine aminotransferase (ALT) during the double-blind treatment period.
Time frame: Weeks 12, 16, 20, and 24
Partial Response
Proportion of participants who achieved a partial response (PR) during the double-blind treatment period of the study.
Time frame: Weeks 12, 16, 20, and 24
Time to Complete Response
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.
Time frame: Baseline through Week 24
Disease Flare After CR
Proportion of participants who experienced a disease flare after complete response (CR) during the double-blind treatment period.
Time frame: Week 24
Treatment Failures
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.
Time frame: Week 24
Complete Response With Glucocorticoid Taper to ≤10 mg
Percentage of participants who achieved complete response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period.
Time frame: Weeks 12, 16, 20, and 24
Complete Response With Glucocorticoid Taper to ≤5 mg
Percentage of participants who achieved complete response and glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period.
Time frame: Weeks 12, 16, 20, and 24
Complete Response With Glucocorticoid Taper to 0 mg
Percentage of participants who achieved complete response with glucocorticoid taper to 0 mg by Week 24 of the double-blind treatment period.
Time frame: Weeks 12, 16, 20, and 24
Partial Response With Glucocorticoid Taper to ≤10 mg
Percentage of participants who achieved partial response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period.
Time frame: Week 24
Partial Response With Glucocorticoid Taper to ≤5 mg
Percentage of participants who achieved partial response and glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period.
Time frame: Week 24
Partial Response With Glucocorticoid Taper to 0 mg
Percentage of participants who achieved partial response with glucocorticoid taper to 0 mg by Week 24 of the double-blind treatment period.
Time frame: Week 24
Change From Baseline in Glucocorticoid Dose
Mean change from Baseline in glucocorticoid dose for participants during the double-blind treatment period at Weeks 12, 16, 20 and 24
Time frame: Weeks 12, 16, 20, and 24
| Milestone | Zetomipzomib + Standard-of-care (Glucocorticoids) | Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Started | 16 | 8 |
| Completed | 13 | 7 |
| Not completed | 3 | 1 |
| Milestone | Zetomipzomib + Standard-of-care (Glucocorticoids) | Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Started | 9 | 5 |
| Completed | 4 | 3 |
| Not completed | 5 | 2 |
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.
| Participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Week 12 | 6 | 3 |
| Week 16 | 7 | 3 |
| Week 20 | 8 | 3 |
| Week 24 | 8 | 3 |
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).
| participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP) | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP) |
|---|---|---|---|---|
| Serious adverse events | 2 | 1 | 0 | 0 |
| Adverse events | 16 | 7 | 9 | 5 |
Proportion of participants experiencing a disease flare among the participants who achieved a complete biochemical response (CR) during the double-blind treatment period.
| participants | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP) | 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 | 0 (0.0 to 52.2) | 0 (0.0 to 84.2) |
Changes from baseline in alanine aminotransferase (ALT) during the double-blind treatment period.
| U/L | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Week 12 | -49.8 ± 67.1 | -47.3 ± 116.5 |
| Week 16 | -46.4 ± 70.4 | -65.8 ± 81.7 |
| Week 20 | -29.4 ± 100.8 | -33.3 ± 113.4 |
| Week 24 | -22.8 ± 103.5 | -80.6 ± 58.0 |
Proportion of participants who achieved a partial response (PR) during the double-blind treatment period of the study.
| Participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Week 12 | 4 | 2 |
| Week 16 | 1 | 0 |
| Week 20 | 1 | 0 |
| Week 24 | 2 | 1 |
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.
| weeks | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Time to Complete Response | NA (8.14 to NA) | NA (4.14 to NA) |
Proportion of participants who experienced a disease flare after complete response (CR) during the double-blind treatment period.
| Participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Disease Flare After CR | 0 | 0 |
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.
| Participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Treatment Failures | 2 | 1 |
Percentage of participants who achieved complete response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period.
| percent of participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| By Week 12 | 18.8 (4.0 to 45.6) | 25.0 (3.2 to 65.1) |
| By Week 16 | 37.5 (15.2 to 64.6) | 25.0 (3.2 to 65.1) |
| By Week 20 | 43.8 (19.8 to 70.1) | 25.0 (3.2 to 65.1) |
| By Week 24 | 43.8 (19.8 to 70.1) | 25.0 (3.2 to 65.1) |
Percentage of participants who achieved complete response and glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period.
| percent of participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| By Week 12 | 12.5 (1.6 to 38.3) | 0 (0 to 36.9) |
| Be Week 16 | 25.0 (7.3 to 52.4) | 12.5 (0.3 to 52.7) |
| By Week 20 | 37.5 (15.2 to 64.6) | 12.5 (0.3 to 52.7) |
| By Week 24 | 37.5 (15.2 to 64.6) | 12.5 (0.3 to 52.7) |
Percentage of participants who achieved complete response with glucocorticoid taper to 0 mg by Week 24 of the double-blind treatment period.
| percent of participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| By Week 12 | 6.3 (0.2 to 30.2) | 0 (0.0 to 36.9) |
| By Week 16 | 6.3 (0.2 to 30.2) | 0 (0.0 to 36.9) |
| By Week 20 | 12.5 (1.6 to 38.3) | 0 (0.0 to 36.9) |
| By Week 24 | 25.0 (7.3 to 52.4) | 0 (0.0 to 36.9) |
Percentage of participants who achieved partial response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period.
| percent of participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Partial Response With Glucocorticoid Taper to ≤10 mg | 31.3 (11.0 to 58.7) | 25.0 (3.2 to 65.1) |
Percentage of participants who achieved partial response and glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period.
| percent of participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Partial Response With Glucocorticoid Taper to ≤5 mg | 12.5 (1.6 to 38.3) | 12.5 (0.3 to 52.7) |
Percentage of participants who achieved partial response with glucocorticoid taper to 0 mg by Week 24 of the double-blind treatment period.
| percent of participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Partial Response With Glucocorticoid Taper to 0 mg | 12.5 (1.6 to 38.3) | 0 (0.0 to 36.9) |
Mean change from Baseline in glucocorticoid dose for participants during the double-blind treatment period at Weeks 12, 16, 20 and 24
| mg/day | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Week 12 | -6.2 ± 9.44 | -3.2 ± 11.70 |
| Week 16 | -8.3 ± 10.59 | -3.0 ± 13.83 |
| Week 20 | -10.0 ± 11.35 | -7.2 ± 10.30 |
| Week 24 | -12.5 ± 9.79 | -4.7 ± 11.43 |
For the subset of the intent to treat population who were on glucocorticoid steroids at Screening, the percentage of participants who achieved complete response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period is presented.
| percent of participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| By Week 12 | 21.4 (4.7 to 50.8) | 14.3 (0.4 to 57.9) |
| By Week 16 | 42.9 (17.7 to 71.1) | 14.3 (0.4 to 57.9) |
| By Week 20 | 50.0 (23.0 to 77.0) | 14.3 (0.4 to 57.9) |
| By Week 24 | 50.0 (23.0 to 77.0) | 14.3 (0.4 to 57.9) |
For the subset of the intent to treat population who were on glucocorticoid steroids at Screening, the percentage of participants who achieved complete response with successful glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period is presented.
| percent of participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| By Week 12 | 14.3 (1.8 to 42.8) | 0 (0.0 to 41.0) |
| By Week 16 | 28.6 (8.4 to 58.1) | 0 (0.0 to 41.0) |
| By Week 20 | 42.9 (17.7 to 71.1) | 0 (0.0 to 41.0) |
| By Week 24 | 42.9 (17.7 to 71.1) | 0 (0.0 to 41.0) |
For the subset of the intent to treat population who were on glucocorticoid steroids at Screening, the percentage of participants who achieved complete response with successful glucocorticoid taper to 0 mg by Week 24 of the double-blind treatment period is presented.
| percent of participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| By Week 12 | 7.1 (0.2 to 33.9) | 0 (0.0 to 41.0) |
| By Week 16 | 7.1 (0.2 to 33.9) | 0 (0.0 to 41.0) |
| By Week 20 | 14.3 (1.8 to 42.8) | 0 (0.0 to 41.0) |
| By Week 24 | 28.6 (8.4 to 58.1) | 0 (0.0 to 41.0) |
For the subset of the intent to treat population who were on glucocorticoid steroids at Screening, the percentage of participants who achieved complete response by Week 24 of the double-blind treatment period is presented.
| percent of participants | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) |
|---|---|---|
| Week 12 | 42.9 (17.7 to 71.1) | 28.6 (3.7 to 71.0) |
| Week 16 | 50.0 (23.0 to 77.0) | 28.6 (3.7 to 71.0) |
| Week 20 | 57.1 (28.9 to 82.3) | 28.6 (3.7 to 71.0) |
| Week 24 | 57.1 (28.9 to 82.3) | 28.6 (3.7 to 71.0) |
Collected over 28 weeks during the double-blind treatment period and up to an additional 28 weeks for participants enrolled in the optional open label extension period. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | 0/16 (0%) | 2/16 (12.5%) | 16/16 (100%) |
| Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | 0/7 (0%) | 1/7 (14.3%) | 7/7 (100%) |
| Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP) | 0/9 (0%) | 0/9 (0%) | 9/9 (100%) |
| Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP) | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP) | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP) |
|---|---|---|---|---|
| Atrial fibrillationCardiac disorders | 0/16 | 1/7 | 0/9 | 0/5 |
| HaematemesisGastrointestinal disorders | 0/16 | 1/7 | 0/9 | 0/5 |
| Oesophageal varices haemorrhageGastrointestinal disorders | 0/16 | 1/7 | 0/9 | 0/5 |
| InfluenzaInfections and infestations | 1/16 | 0/7 | 0/9 | 0/5 |
| Post procedural feverInjury, poisoning and procedural complications | 1/16 | 0/7 | 0/9 | 0/5 |
| Event | Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids) | Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids) | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP) | Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP) |
|---|---|---|---|---|
| ChillsGeneral disorders and administration site conditions | 9/16 | 2/7 | 6/9 | 4/5 |
| Injection site indurationGeneral disorders and administration site conditions | 5/16 | 0/7 | 1/9 | 4/5 |
| Injection site erythemaGeneral disorders and administration site conditions | 12/16 | 2/7 | 3/9 | 3/5 |
| Injection site painGeneral disorders and administration site conditions | 10/16 | 1/7 | 3/9 | 3/5 |
| NauseaGastrointestinal disorders | 6/16 | 2/7 | 4/9 | 3/5 |
| HeadacheNervous system disorders | 9/16 | 4/7 | 4/9 | 3/5 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/16 | 1/7 | 0/9 | 3/5 |
| Nasal congestionRespiratory, thoracic and mediastinal disorders | 0/16 | 0/7 | 0/9 | 3/5 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/16 | 0/7 | 0/9 | 3/5 |
| Injection site bruisingGeneral disorders and administration site conditions | 7/16 | 4/7 | 2/9 | 1/5 |
The baseline characteristics are presented for the Full Analysis Set (N=23), all randomized patients who received at least 1 dose of IMP in this study and have Baseline and at least one post-treatment value for all the following measures: ALT, AST, and IgG. One participant was randomized to the placebo group but never dosed and is therefore not included in the Full Analysis Set or the Safety Analysis Set but is included in the Intent to Treat Analysis Set.
| Age, Continuous(years) | Zetomipzomib + Standard-of-care (Glucocorticoids) | Placebo + Standard-of-care (Glucocorticoids) | Total |
|---|---|---|---|
| Mean | 54.4 ± 15.6 | 48.9 ± 19.7 | 52.7 ± 16.7 |
| Sex: Female, Male(Participants) | Zetomipzomib + Standard-of-care (Glucocorticoids) | Placebo + Standard-of-care (Glucocorticoids) | Total |
|---|---|---|---|
| Female | 8 | 5 | 13 |
| Male | 8 | 2 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Zetomipzomib + Standard-of-care (Glucocorticoids) | Placebo + Standard-of-care (Glucocorticoids) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 14 | 6 | 20 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Zetomipzomib + Standard-of-care (Glucocorticoids) | Placebo + Standard-of-care (Glucocorticoids) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| Native Hawaiian | 0 | 0 | 0 |
| White | 13 | 6 | 19 |
| Asian Indian | 0 | 0 | 0 |
| Chinese | 0 | 0 | 0 |
| Filipino | 0 | 0 | 0 |
| Japanese | 0 | 0 | 0 |
| Korean | 0 | 0 | 0 |
| Vietnamese | 0 | 0 | 0 |
| Other Asian | 0 | 0 | 0 |
| Guamanian or Chamorro | 0 | 0 | 0 |
| Samoan | 0 | 0 | 0 |
| Other Pacific Islander | 0 | 0 | 0 |
| Other | 2 | 0 | 2 |
| Multi-Racial | 0 | 0 | 0 |
| Baseline ALT(U/L) | Zetomipzomib + Standard-of-care (Glucocorticoids) | Placebo + Standard-of-care (Glucocorticoids) | Total |
|---|---|---|---|
| Mean | 106.7 ± 49.0 | 143.4 ± 75.2 | 117.9 ± 59.0 |
| Baseline AST(U/L) | Zetomipzomib + Standard-of-care (Glucocorticoids) | Placebo + Standard-of-care (Glucocorticoids) | Total |
|---|---|---|---|
| Mean | 79.5 ± 50.4 | 107.0 ± 40.6 | 87.8 ± 48.4 |
| Baseline IgG(mg/dL) | Zetomipzomib + Standard-of-care (Glucocorticoids) | Placebo + Standard-of-care (Glucocorticoids) | Total |
|---|---|---|---|
| Mean | 1865.3 ± 842.5 | 1985.1 ± 579.2 | 1901.7 ± 760.7 |
| Baseline IgG (Abnormal at Baseline)(mg/dL) | Zetomipzomib + Standard-of-care (Glucocorticoids) | Placebo + Standard-of-care (Glucocorticoids) | Total |
|---|---|---|---|
| Mean | 2396.7 ± 751.8 | 2213.0 ± 514.5 | 2331.1 ± 661.5 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2023 to primary completion in Apr 2025, 23 months.
Results were first posted in Jan 2026, 8 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: KZR-616
Kezar Life Sciences, Inc.