A Phase 1/2 interventional study of KZR-616 in Lupus Nephritis and Systemic Lupus Erythematosus, sponsored by Kezar Life Sciences, Inc.. Completed at 36 sites in 8 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by Kezar Life Sciences, Inc. · Phase 1/2, Interventional, and Treatment
This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).
This was a Phase 1b/2, open-label, multi-center study in which patients received zetomipzomib administered as a SC injection weekly for either 13 weeks (Phase 1b) or for 24 weeks (Phase 2). In both phases, safety assessments continued for up to 12 weeks following the last dose of zetomipzomib.
Phase 1b was an open-label, multiple dose escalation study designed to evaluate the safety and tolerability of escalating doses of zetomipzomib when administered in addition to standard-of-care therapy in patients with SLE with or without nephritis. For each cohort, at least 6 patients were to be enrolled to assure the availability of at least 4 evaluable patients. Decisions to escalate, expand, or decrease the dose level or dosing frequency following the first 4 weeks of dosing for at least 4 evaluable patients in a cohort were made following review by a data monitoring committee (DMC).
The zetomipzomib formulations and doses administered by cohort in Phase 1b were:
The Phase 2 portion of the open-label study was designed to evaluate the renal response, safety, and tolerability of a single dose level (60 mg) of zetomipzomib administered weekly in addition to standard therapy in patients with active proliferative lupus nephritis (LN) (Class III or IV, with or without Class V disease) with a UPCR ≥1.0. Patients must have been on standard therapy for LN including at least 1 immunosuppressive agent. Zetomipzomib was administered as a SC injection weekly for 24 weeks (including a step up from an initial Week 1 dose of 30 mg).
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
This study's enrollment of 69 is above the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Browse Lupus Nephritis 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:
Phase 1b:
Phase 2:
Key Exclusion Criteria:
Phase 1b:
Current or medical history of:
Phase 2:
Current or medical history of:
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.
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 weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose escalation cohort of patients with SLE with and without nephritis to receive 45 mg dose level of KZR-616 in combination with standard of care therapy. Two Phase 1b cohorts received 45 mg at some point during the study. Cohort 1 received 45 mg zetomipzomib frozen maleate weekly for 13 weeks. Cohort 2a followed a step-up dosing procedure. Patients received zetomipzomib frozen maleate, 30 mg weekly for 2 weeks, followed by 45 mg weekly for 2 weeks then followed by 60 mg weekly for 9 weeks. KZR-616 was administered as a SC injection.
Drug: KZR-616
Dose escalation cohort of patients with SLE with and without nephritis to receive 60 mg dose level of KZR-616 in combination with standard of care therapy. Four Phase 1b cohorts received 60 mg at some point during the study. Cohort 2 received 60 mg zetomipzomib frozen maleate weekly for 13 weeks. Cohorts 2a, 2b, and 2c all followed a step-up dosing procedure. Patients in Cohort 2a received zetomipzomib frozen maleate, 30 mg weekly for 2 weeks, followed by 45 mg weekly for 2 weeks then followed by 60 mg weekly for 9 weeks. Patients in Cohort 2b received zetomipzomib lyophile, 30 mg weekly for 1 week, followed by 60 mg weekly for 12 weeks. Patients in Cohort 2c (tolerability strategies cohort) received zetomipzomib lyophile, 30 mg weekly for 1 week, followed by 60 mg weekly for 12 weeks. KZR-616 was administered as a SC injection.
Drug: KZR-616
Dose escalation cohort of patients with SLE with and without nephritis to receive 75 mg dose level of KZR-616 in combination with standard of care therapy. One Phase 1b cohort received 75 mg at some point during the study. Cohort 3 followed a step-up dosing procedure. Patients in Cohort 3 received zetomipzomib lyophile, 30 mg weekly for 1 week, followed by 75 mg weekly for 12 weeks. KZR-616 was administered as a SC injection.
Drug: KZR-616
60 mg dose level of KZR-616 selected based on data from the phase 1b dose escalation and administered to patients with active lupus nephritis in combination with standard therapy including at least one immunosuppressive agent. KZR-616 was administered as a SC injection weekly at a dose of 60 mg for 24 weeks (including a step-up from an initial Week 1 dose of 30 mg). \*\* See Limitations/Caveats for additional information
Drug: KZR-616
Subcutaneous Injection of KZR-616
Also known as: zetomipzomib
Phase 1b: Number of Patients Who Experienced at Least One Treatment-Related Treatment-Emergent Adverse Event
The safety and tolerability of zetomipzomib (KZR-616) when administered as a subcutaneous injection weekly for 13 weeks in adult patients with systemic lupus erythematous (SLE) with and without nephritis, as assessed by number of patients who experienced at least one treatment-related treatment-emergent adverse event. For additional information about the safety and tolerability of KZR-616, please reference the adverse events section of this posting.
Time frame: 25 weeks
Phase 2: Number of Patients With Lupus Nephritis With a 50% Reduction in UPCR
To assess the number of patients with lupus nephritis with a 50% reduction in UPCR after 24 weeks of weekly SC injections with KZR-616 when compared to baseline.
Time frame: 24 weeks
Phase 1b: PK of KZR-616 (Cmax)
This is the maximum observed plasma concentration (Cmax) observed after administration of KZR-616 at Week 5. The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 5, 15, 30 minutes, 1, 2, 4, and 8 hours postdose.
Time frame: 8 hours
Phase 1b: PK of KZR-616 (Tmax)
This is the time to maximum observed plasma concentration (tmax) observed after administration of KZR-616 at Week 5. The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 5, 15, 30 minutes, 1, 2, 4, and 8 hours postdose.
Time frame: 8 hours
Phase 1b: PK of KZR-616 (AUC)
This is the area under the curve (AUC) from predose through 8 hour postdose observed after administration of KZR-616 at Week 5. The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 5, 15, 30 minutes, 1, 2, 4, and 8 hours postdose.
Time frame: 8 hours
Phase 2: Number of Patients With a Partial Renal Response
Number of patients with a partial renal response (PRR) after 24 weeks of treatment, as defined by: 1. For this outcome measure, Primary UPCR criterion was used (a 50% reduction of UPCR and reduction of UPCR to \<1.0 if baseline UPCR was \<3.0 (or reduction of UPCR to \<3.0 if baseline was ≥3.0)) 2. eGFR of greater than or equal to 60 mL/min/1.73 m\^2 or no worsening of eGFR from baseline of greater than or equal to 25% 3. No use of prohibited medication Count of patients below includes those who satisfy all three of the above criteria.
Time frame: 24 weeks
Phase 2: Safety and Tolerability of KZR-616 When Administered as a SC Injection Weekly for 24 Weeks
Exposure adjusted adverse event incidence rate for Injection Site Reactions and Systemic Injection Reactions. For additional information about the safety and tolerability of KZR-616, please reference the adverse events section of this posting.
Time frame: 37 weeks
Phase 1b: Recommended Phase 2 Doses of Zetomipzomib When Administered as a Subcutaneous Injection
The safety data from Phase 1b were used to determine a recommended dose of zetomipzomib to administer to patients with active proliferative lupus nephritis in Phase 2 of this study. As pre-specified in the study protocol, this outcome measure was to be determined qualitatively through discussion of relevant information from the Phase 1b portion of the trial at a data monitoring committee meeting.
Time frame: 25 weeks
Patients who were enrolled in Phase 1b were ineligible to enroll in the Phase 2 portion of the study.
| Milestone | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | KZR-616 QW, 60 mg + SOC (Phase 2) |
|---|---|---|---|---|---|---|---|
| Started | 8 | 5 | 14 | 6 | 8 | 6 | 0 |
| Completed | 5 | 2 | 10 | 6 | 8 | 4 | 0 |
| Not completed | 3 | 3 | 4 | 0 | 0 | 2 | 0 |
| Milestone | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | KZR-616 QW, 60 mg + SOC (Phase 2) |
|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 22 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 18 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 4 |
The safety and tolerability of zetomipzomib (KZR-616) when administered as a subcutaneous injection weekly for 13 weeks in adult patients with systemic lupus erythematous (SLE) with and without nephritis, as assessed by number of patients who experienced at least one treatment-related treatment-emergent adverse event. For additional information about the safety and tolerability of KZR-616, please reference the adverse events section of this posting.
| Participants | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) |
|---|---|---|---|---|---|---|
| Phase 1b: Number of Patients Who Experienced at Least One Treatment-Related Treatment-Emergent Adverse Event | 7 | 5 | 11 | 3 | 6 | 3 |
To assess the number of patients with lupus nephritis with a 50% reduction in UPCR after 24 weeks of weekly SC injections with KZR-616 when compared to baseline.
| Participants | KZR-616 QW, 60 mg + SOC (Phase 2) |
|---|---|
| Phase 2: Number of Patients With Lupus Nephritis With a 50% Reduction in UPCR | 11 |
This is the maximum observed plasma concentration (Cmax) observed after administration of KZR-616 at Week 5. The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 5, 15, 30 minutes, 1, 2, 4, and 8 hours postdose.
| ng/mL | KZR-616 30 mg + Standard of Care Therapy | KZR-616 45 mg + Standard of Care Therapy (Phase 1b) | KZR-616 60 mg + Standard of Care Therapy (Phase 1b) | KZR-616 75 mg + Standard of Care Therapy (Phase 1b) |
|---|---|---|---|---|
| Phase 1b: PK of KZR-616 (Cmax) | 74.2 | 134 ± 45.6 | 151 ± 50.3 | 265 ± 60.4 |
This is the time to maximum observed plasma concentration (tmax) observed after administration of KZR-616 at Week 5. The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 5, 15, 30 minutes, 1, 2, 4, and 8 hours postdose.
| hours | KZR-616 30 mg + Standard of Care Therapy | KZR-616 45 mg + Standard of Care Therapy (Phase 1b) | KZR-616 60 mg + Standard of Care Therapy (Phase 1b) | KZR-616 75 mg + Standard of Care Therapy (Phase 1b) |
|---|---|---|---|---|
| Phase 1b: PK of KZR-616 (Tmax) | 1.00 | 0.25 (0.13 to 1.00) | 0.25 (0.08 to 2.00) | 0.50 (0.25 to 0.52) |
This is the area under the curve (AUC) from predose through 8 hour postdose observed after administration of KZR-616 at Week 5. The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 5, 15, 30 minutes, 1, 2, 4, and 8 hours postdose.
| ng*h/ml | KZR-616 30 mg + Standard of Care Therapy | KZR-616 45 mg + Standard of Care Therapy (Phase 1b) | KZR-616 60 mg + Standard of Care Therapy (Phase 1b) | KZR-616 75 mg + Standard of Care Therapy (Phase 1b) |
|---|---|---|---|---|
| Phase 1b: PK of KZR-616 (AUC) | 258 | 387 ± 38.1 | 430 ± 36.8 | 636 ± 31.7 |
Number of patients with a partial renal response (PRR) after 24 weeks of treatment, as defined by: 1. For this outcome measure, Primary UPCR criterion was used (a 50% reduction of UPCR and reduction of UPCR to \<1.0 if baseline UPCR was \<3.0 (or reduction of UPCR to \<3.0 if baseline was ≥3.0)) 2. eGFR of greater than or equal to 60 mL/min/1.73 m\^2 or no worsening of eGFR from baseline of greater than or equal to 25% 3. No use of prohibited medication Count of patients below includes those who satisfy all three of the above criteria.
| Participants | KZR-616 QW, 60 mg + SOC (Phase 2) |
|---|---|
| Phase 2: Number of Patients With a Partial Renal Response | 10 |
Exposure adjusted adverse event incidence rate for Injection Site Reactions and Systemic Injection Reactions. For additional information about the safety and tolerability of KZR-616, please reference the adverse events section of this posting.
| events per person-weeks | KZR-616 QW, 60 mg + SOC (Phase 2) |
|---|---|
| Injection Site Reactions | 0.036 |
| Systemic Injection Reactions | 0.045 |
The safety data from Phase 1b were used to determine a recommended dose of zetomipzomib to administer to patients with active proliferative lupus nephritis in Phase 2 of this study. As pre-specified in the study protocol, this outcome measure was to be determined qualitatively through discussion of relevant information from the Phase 1b portion of the trial at a data monitoring committee meeting.
| mg | All Phase 1b Patients (Cohort 1, Cohort 2a-c, Cohort 3) |
|---|---|
| Phase 1b: Recommended Phase 2 Doses of Zetomipzomib When Administered as a Subcutaneous Injection | 60 |
Changes in lupus disease assessments and changes from baseline in laboratory measures \- Renal parameters (UPCR) in Patients with SLE who had active lupus nephritis at baseline, 13 weeks (end of treatment), and 25 weeks (end of study)
| g/g | Patient 1 | Patient 2 |
|---|---|---|
| Baseline | 3.85 | 2.39 |
| Week 13 (End of Treatment) | 2.89 | 0.69 |
| Week 25 (End of Study) | 1.12 | 1.47 |
Collected over The adverse event data was collected starting at the time of signed informed consent and were collected until 12 weeks after last dose. This time period was approximately 25 and 37 weeks for each participant in Phase 1b and Phase 2, respectively.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | 0/8 (0%) | 0/8 (0%) | 8/8 (100%) |
| Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | 0/5 (0%) | 1/5 (20%) | 5/5 (100%) |
| Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | 0/14 (0%) | 2/14 (14.3%) | 12/14 (85.7%) |
| Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | 0/6 (0%) | 1/6 (16.7%) | 4/6 (66.7%) |
| Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | 0/8 (0%) | 0/8 (0%) | 7/8 (87.5%) |
| Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| KZR-616 QW, 60 mg + SOC (Phase 2) | 0/22 (0%) | 2/22 (9.1%) | 22/22 (100%) |
| Event | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | KZR-616 QW, 60 mg + SOC (Phase 2) |
|---|---|---|---|---|---|---|---|
| Thrombotic microangiopathyBlood and lymphatic system disorders | 0/8 | 1/5 | 0/14 | 0/6 | 0/8 | 0/6 | 0/22 |
| Viral infectionInfections and infestations | 0/8 | 0/5 | 0/14 | 1/6 | 0/8 | 0/6 | 0/22 |
| Systemic inflammatory response syndromeGeneral disorders | 0/8 | 0/5 | 1/14 | 0/6 | 0/8 | 0/6 | 0/22 |
| Herpes zosterInfections and infestations | 0/8 | 0/5 | 1/14 | 0/6 | 0/8 | 0/6 | 0/22 |
| Urinary tract infectionInfections and infestations | 0/8 | 0/5 | 0/14 | 0/6 | 0/8 | 0/6 | 1/22 |
| MigraineNervous system disorders | 0/8 | 0/5 | 0/14 | 0/6 | 0/8 | 0/6 | 1/22 |
| Acute kidney injuryRenal and urinary disorders | 0/8 | 0/5 | 0/14 | 0/6 | 0/8 | 0/6 | 1/22 |
| Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders | 0/8 | 0/5 | 0/14 | 0/6 | 0/8 | 0/6 | 1/22 |
| Event | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | KZR-616 QW, 60 mg + SOC (Phase 2) |
|---|---|---|---|---|---|---|---|
| VomitingGastrointestinal disorders | 1/8 | 5/5 | 3/14 | 1/6 | 2/8 | 1/6 | 9/22 |
| NauseaGastrointestinal disorders | 2/8 | 4/5 | 5/14 | 1/6 | 4/8 | 3/6 | 9/22 |
| Injection site erythemaGeneral disorders | 5/8 | 2/5 | 5/14 | 2/6 | 6/8 | 0/6 | 12/22 |
| PyrexiaGeneral disorders | 0/8 | 2/5 | 3/14 | 1/6 | 2/8 | 3/6 | 13/22 |
| HeadacheNervous system disorders | 1/8 | 2/5 | 3/14 | 3/6 | 2/8 | 1/6 | 11/22 |
| Injection site indurationGeneral disorders | 1/8 | 2/5 | 0/14 | 0/6 | 0/8 | 1/6 | 5/22 |
| DizzinessNervous system disorders | 1/8 | 2/5 | 0/14 | 0/6 | 0/8 | 0/6 | 2/22 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/8 | 0/5 | 0/14 | 0/6 | 3/8 | 0/6 | 2/22 |
| Abdominal distensionGastrointestinal disorders | 0/8 | 0/5 | 0/14 | 0/6 | 0/8 | 2/6 | 2/22 |
| PainGeneral disorders | 0/8 | 0/5 | 0/14 | 0/6 | 2/8 | 2/6 | 3/22 |
| Age, Continuous(years) | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | KZR-616 QW, 60 mg + SOC (Phase 2) | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 51.9 ± 11.5 | 46.2 ± 11.3 | 53.6 ± 15.3 | 54.3 ± 14.8 | 48.1 ± 10.3 | 45.0 ± 17.5 | 34.6 ± 11.7 | 45.5 ± 14.9 |
| Sex: Female, Male(Participants) | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | KZR-616 QW, 60 mg + SOC (Phase 2) | Total |
|---|---|---|---|---|---|---|---|---|
| Female | 8 | 5 | 12 | 6 | 8 | 6 | 20 | 65 |
| Male | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | KZR-616 QW, 60 mg + SOC (Phase 2) | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 4 | 3 | 10 | 2 | 5 | 3 | 12 | 39 |
| Not Hispanic or Latino | 4 | 2 | 4 | 4 | 3 | 3 | 10 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | KZR-616 QW, 60 mg + SOC (Phase 2) | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 4 |
| Asian | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 1 | 2 | 1 | 3 | 1 | 11 |
| White | 7 | 3 | 12 | 4 | 7 | 3 | 7 | 43 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 9 | 9 |
| UPCR at Baseline(mg/mg) | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | KZR-616 QW, 60 mg + SOC (Phase 2) | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | — | — | 3.85 | — | 2.39 | — | 2.50 ± 2.56 | 2.55 ± 2.46 |
| eGFR Level at Baseline(mL/min/1.73 m^2) | Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b) | Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b) | Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b) | Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b) | Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b) | KZR-616 QW, 60 mg + SOC (Phase 2) | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | — | — | — | — | — | — | 104.71 ± 32.579 | 104.71 ± 32.579 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Aug 2022, 53 months.
Results were first posted in Mar 2024, 1 year 7 months after primary completion.
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Studies of the drug tested here: KZR-616
Kezar Life Sciences, Inc.