A Phase 2 interventional study of KZR-616 and Placebo in Polymyositis and Dermatomyositis, sponsored by Kezar Life Sciences, Inc.. Completed at 14 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Kezar Life Sciences, Inc. · Phase 2, Interventional, and Treatment
This was a Phase 2 randomized, double-blind, placebo-controlled, crossover, multicenter study to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of treatment with KZR-616 in patients with active polymyositis (PM) or dermatomyositis (DM). Patients were evaluated for eligibility during the Screening Period. Eligible patients were stratified by diagnosis of DM or PM and randomized 1:1 to Arm A or Arm B of the study.
During the 32-week treatment period, patients received study drug subcutaneously (SC) once weekly with 2 treatment periods of 16 weeks each.
This study was conducted on an outpatient basis.
184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.
This study's enrollment of 25 is below the median of 35 across 130 interventional studies indexed under Dermatomyositis.
Browse Dermatomyositis 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.
Compared within Dermatomyositis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Polymyositis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must have their data reviewed by an adjudication committee to confirm eligibility unless at least 1 of the following is present:
Must have demonstrable muscle weakness as measured by the Manual Muscle Testing-8 muscle Groups (MMT-8) with a score ≥80/150 but ≤136/150 units and any 2 of the following:
Exclusion Criteria:
Any of the following laboratory values at Screening:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Treatment Period 1: KZR-616 30 mg SC weekly for 2 weeks, then 45 mg SC weekly for 14 weeks * Treatment Period 2: Placebo SC weekly for 16 weeks
Drug: KZR-616 · Drug: Placebo
* Treatment Period 1: Placebo SC weekly for 16 weeks * Treatment Period 2: KZR-616 30 mg SC weekly for 2 weeks, then 45 mg SC weekly for 14 weeks
Drug: KZR-616 · Drug: Placebo
Subcutaneous 30 mg weekly for 2 weeks, then 45 mg weekly for 14 weeks
Also known as: zetomipzomib
Subcutaneous injection for 16 weeks
Mean Change in the Total Improvement Score (TIS) From Start to End of Zetomipzomib (KZR-616) Treatment Period
The primary efficacy endpoint was mean change from start to end of zetomipzomib (KZR-616) Treatment Periods in the Total Improvement Score (TIS), which ranges from 0 to 100 \[low of 0 to high of 100, where higher scores are better\]. Mean change in TIS was calculated by comparing the Baseline and post Baseline observations for patients in both KZR-616 treatment periods combined. Note: TIS scores for placebo treatment periods are presented in this outcome measure but were not included in the primary outcome measure analysis.
Time frame: 16 weeks in each Treatment Period (32 weeks total)
Proportion of Patients With TIS Response
The proportion of patients with an increase of ≥ 20 points on the TIS from start to end of zetomipzomib (KZR-616) treatment. TIS response is categorized by the following improvement thresholds: * Minimal response = TIS ≥ 20 * Moderate response = TIS ≥ 40 * Major response = TIS ≥ 60 This endpoint was assessed by comparing Week 16 versus Week 0 for patients allocated to Arm A and Week 32 versus Week 16 for patients allocated to Arm B. This re-baselining approach was utilized to maximize the precision for assessment of zetomipzomib effect in Arm B.
Time frame: 16 weeks in each Treatment Period (32 weeks total)
Number of Patients Meeting the International Myositis Assessment and Clinical Studies Group (IMACS) Definition of Improvement (DOI)
The IMACS DOI is ≥ 20% improvement in at least 3 of 6 core set activity measures, with no more than 2 core set activity measures (CSAMs) worsening by ≥ 25% (Manual Muscle Testing-8 Muscle Groups \[MMT-8\] could not be a worsening measure).
Time frame: 16 weeks in each Treatment Period (32 weeks total)
Mean Percent Change From Baseline From Start to End of Treatment in the IMACS Individual CSAMs
Mean percent change from baseline of the IMACS CSAMs consisting of: * Physician Global Assessment: physician assessment of patient's overall disease activity at present, high numbers indicate more severe disease activity \[0-10\] * Patient Global Assessments of Disease Activity: patient assessment of their overall disease activity at present, high numbers indicate more severe disease activity \[0-100\] * Manual Muscle Testing-8 Muscle Groups: scores range from 0 - 150, high scores are better * Health Assessment Questionnaire-Disability Index: scores range from 0 - 3, high scores are worse * Extramuscular Global Assessment of the Myositis Disease Activity Assessment Tool (2005 version): scores range from 0 - 10, high scores are worse * Muscle enzymes (clinical laboratory assessments \[CLA\]): Summarize the most abnormal CLA (creatine kinase \[CK\], aldolase, lactate dehydrogenase \[LDH\], alanine aminotransferase \[ALT\], or aspartate aminotransferase \[AST\]) at baseline, lower scores are better
Time frame: 16 weeks in each Treatment Period (32 weeks total)
Mean Change in CDASI From Start to End of Zetomipzomib (KZR-616) Treatment
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) is a clinician scored single-page instrument that separately measures activity and damage, which consists of three (3) activity measures and two (2) damage measures which are assessed over 15 body areas. Scores range from 0-100 for activity and from 0-32 for damage, with higher scores indicating more severe disease.
Time frame: 16 weeks in each Treatment Period (32 weeks total)
Mean Change in PP-NRS From Start to End of Zetomipzomib (KZR-616) Treatment
The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to evaluate severity of itch in DM patients. Scores range from 0-10, with zero (0) representing no itch and ten (10) representing the worst itch imaginable within a 24-hour recall period.
Time frame: 16 weeks in each Treatment Period (32 weeks total)
PK of Zetomipzomib [KZR-616] (Cmax)
This is the maximum observed plasma concentration (Cmax) observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The pharmacokinetic (PK) parameters were calculated using all timepoints at which the concentration was measured, ie. pre-dose and 30 minutes, and 4 hours post-dose, with an additional sample obtained at 0.25, 1, or 2 hours post-dose.
Time frame: Up to 5 hours
PK of Zetomipzomib [KZR-616] (Tmax)
This is the time to maximum observed plasma concentration (tmax) observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 30 minutes, and 4 hours postdose, with an additional sample obtained at 0.25, 1, or 2 hours postdose.
Time frame: Up to 5 hours
PK of Zetomipzomib [KZR-616] (AUC)
This is the area under the curve (AUC) from predose through 4 hour postdose observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 30 minutes, and 4 hours postdose, with an additional sample obtained at 0.25, 1, or 2 hours postdose.
Time frame: Up to 5 hours
PK of KZR-59587 (Cmax)
This is the maximum observed plasma concentration of KZR-59587 (Cmax) observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The pharmacokinetic (PK) parameters were calculated using all timepoints at which the concentration was measured, ie. pre-dose and 30 minutes, and 4 hours post-dose, with an additional sample obtained at 0.25, 1, or 2 hours post-dose.
Time frame: Up to 5 hours
PK of KZR-59587 (Tmax)
This is the time to maximum observed plasma concentration of KZR-59587 (tmax) observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 30 minutes, and 4 hours postdose, with an additional sample obtained at 0.25, 1, or 2 hours postdose.
Time frame: Up to 5 hours
PK of KZR-59587 (AUC)
This is the area under the curve of KZR-59587 (AUC) from predose through 4 hour postdose observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 30 minutes, and 4 hours postdose, with an additional sample obtained at 0.25, 1, or 2 hours postdose.
Time frame: Up to 5 hours
| Milestone | Zetomipzomib First, Then Placebo (Arm A) | Placebo First, Then Zetomipzomib (Arm B) |
|---|---|---|
| Started | 13 | 12 |
| Completed | 10 | 12 |
| Not completed | 3 | 0 |
| Milestone | Zetomipzomib First, Then Placebo (Arm A) | Placebo First, Then Zetomipzomib (Arm B) |
|---|---|---|
| Started | 10 | 12 |
| Completed | 8 | 12 |
| Not completed | 2 | 0 |
The primary efficacy endpoint was mean change from start to end of zetomipzomib (KZR-616) Treatment Periods in the Total Improvement Score (TIS), which ranges from 0 to 100 \[low of 0 to high of 100, where higher scores are better\]. Mean change in TIS was calculated by comparing the Baseline and post Baseline observations for patients in both KZR-616 treatment periods combined. Note: TIS scores for placebo treatment periods are presented in this outcome measure but were not included in the primary outcome measure analysis.
| score on a scale | Arm A: Period 1 (Zetomipzomib) | Arm B: Period 1 (Placebo) | Arm A: Period 2 (Placebo) | Arm B: Period 2 (Zetomipzomib) |
|---|---|---|---|---|
| Mean Change in the Total Improvement Score (TIS) From Start to End of Zetomipzomib (KZR-616) Treatment Period | 25.5 ± 18.6 | 25.0 ± 19.9 | 33.1 ± 17.6 | 33.5 ± 22.9 |
The proportion of patients with an increase of ≥ 20 points on the TIS from start to end of zetomipzomib (KZR-616) treatment. TIS response is categorized by the following improvement thresholds: * Minimal response = TIS ≥ 20 * Moderate response = TIS ≥ 40 * Major response = TIS ≥ 60 This endpoint was assessed by comparing Week 16 versus Week 0 for patients allocated to Arm A and Week 32 versus Week 16 for patients allocated to Arm B. This re-baselining approach was utilized to maximize the precision for assessment of zetomipzomib effect in Arm B.
| participants | Arm A: Period 1 (Zetomipzomib) | Arm B: Period 1 (Placebo) | Arm A: Period 2 (Placebo) | Arm B: Period 2 (Zetomipzomib) |
|---|---|---|---|---|
| Minimal (TIS ≥ 20) | 6 | 7 | 1 | 6 |
| Moderate (TIS ≥ 40) | 2 | 2 | 1 | 2 |
| Major (TIS ≥ 60) | 0 | 1 | 0 | 1 |
The IMACS DOI is ≥ 20% improvement in at least 3 of 6 core set activity measures, with no more than 2 core set activity measures (CSAMs) worsening by ≥ 25% (Manual Muscle Testing-8 Muscle Groups \[MMT-8\] could not be a worsening measure).
| participants | Arm A: Period 1 (Zetomipzomib) | Arm B: Period 1 (Placebo) | Arm A: Period 2 (Placebo) | Arm B: Period 2 (Zetomipzomib) |
|---|---|---|---|---|
| Number of Patients Meeting the International Myositis Assessment and Clinical Studies Group (IMACS) Definition of Improvement (DOI) | 1 | 1 | 1 | 3 |
Mean percent change from baseline of the IMACS CSAMs consisting of: * Physician Global Assessment: physician assessment of patient's overall disease activity at present, high numbers indicate more severe disease activity \[0-10\] * Patient Global Assessments of Disease Activity: patient assessment of their overall disease activity at present, high numbers indicate more severe disease activity \[0-100\] * Manual Muscle Testing-8 Muscle Groups: scores range from 0 - 150, high scores are better * Health Assessment Questionnaire-Disability Index: scores range from 0 - 3, high scores are worse * Extramuscular Global Assessment of the Myositis Disease Activity Assessment Tool (2005 version): scores range from 0 - 10, high scores are worse * Muscle enzymes (clinical laboratory assessments \[CLA\]): Summarize the most abnormal CLA (creatine kinase \[CK\], aldolase, lactate dehydrogenase \[LDH\], alanine aminotransferase \[ALT\], or aspartate aminotransferase \[AST\]) at baseline, lower scores are better
| percent change | Arm A: Period 1 (Zetomipzomib) | Arm B: Period 1 (Placebo) | Arm A: Period 2 (Placebo) | Arm B: Period 2 (Zetomipzomib) |
|---|---|---|---|---|
| Physician Global Assessment (MDGA) | -32.5 ± 35.1 | -22.1 ± 36.8 | 81.7 ± 204.3 | -4.5 ± 58.6 |
| Patient Global Assessments of Disease Activity (PtGADA) | -23.1 ± 35.1 | -21.7 ± 49.8 | 48.6 ± 121.4 | 64.4 ± 163.8 |
| Manual Muscle Testing-8 Muscle Groups (MMT-8) | 6.7 ± 8.6 | 5.6 ± 6.1 | 0.2 ± 4.6 | 1.5 ± 7.1 |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) | -28.2 ± 34.4 | 1.2 ± 80.5 | 19.2 ± 51.2 | -8.8 ± 60.4 |
| The Extramuscular Global Assessment of the Myositis Disease Activity Assessment Tool (MDAAT) | -14.6 ± 75.2 | -14.7 ± 68.7 | 0.8 ± 69.4 | -34.8 ± 47.5 |
| Muscle enzymes (clinical laboratory assessments) | -19.8 ± 24.1 | 8.7 ± 44.2 | -3.9 ± 42.6 | -8.3 ± 50.6 |
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) is a clinician scored single-page instrument that separately measures activity and damage, which consists of three (3) activity measures and two (2) damage measures which are assessed over 15 body areas. Scores range from 0-100 for activity and from 0-32 for damage, with higher scores indicating more severe disease.
| score on a scale | Arm A: Period 1 (Zetomipzomib) | Arm B: Period 1 (Placebo) | Arm A: Period 2 (Placebo) | Arm B: Period 2 (Zetomipzomib) |
|---|---|---|---|---|
| Activity Score | -2.2 ± 5.3 | -1.2 ± 13.5 | -4.4 ± 5.2 | -0.2 ± 16.1 |
| Damage Score | 0.0 ± 0.7 | -0.8 ± 2.1 | -0.2 ± 0.8 | -1.7 ± 3.1 |
The Peak Pruritus Numeric Rating Scale (PP-NRS) is used to evaluate severity of itch in DM patients. Scores range from 0-10, with zero (0) representing no itch and ten (10) representing the worst itch imaginable within a 24-hour recall period.
| score on a scale | Arm A: Period 1 (Zetomipzomib) | Arm B: Period 1 (Placebo) | Arm A: Period 2 (Placebo) | Arm B: Period 2 (Zetomipzomib) |
|---|---|---|---|---|
| Mean Change in PP-NRS From Start to End of Zetomipzomib (KZR-616) Treatment | -1.8 ± 1.3 | -2.0 ± 4.2 | -2.0 ± 1.9 | -3.5 ± 3.5 |
This is the maximum observed plasma concentration (Cmax) observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The pharmacokinetic (PK) parameters were calculated using all timepoints at which the concentration was measured, ie. pre-dose and 30 minutes, and 4 hours post-dose, with an additional sample obtained at 0.25, 1, or 2 hours post-dose.
| ng/mL | Zetomipzomib (Arm A: Period 1) | Zetomipzomib (Arm B: Period 2) |
|---|---|---|
| PK of Zetomipzomib [KZR-616] (Cmax) | 57.5 ± 78.9 | 82.3 ± 42.5 |
This is the time to maximum observed plasma concentration (tmax) observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 30 minutes, and 4 hours postdose, with an additional sample obtained at 0.25, 1, or 2 hours postdose.
| hours | Zetomipzomib (Arm A: Period 1) | Zetomipzomib (Arm B: Period 2) |
|---|---|---|
| PK of Zetomipzomib [KZR-616] (Tmax) | 0.50 (0.25 to 0.53) | 0.50 (0.25 to 0.55) |
This is the area under the curve (AUC) from predose through 4 hour postdose observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 30 minutes, and 4 hours postdose, with an additional sample obtained at 0.25, 1, or 2 hours postdose.
| ng*h/mL | Zetomipzomib (Arm A: Period 1) | Zetomipzomib (Arm B: Period 2) |
|---|---|---|
| PK of Zetomipzomib [KZR-616] (AUC) | 120 ± 59.0 | 156 ± 40.4 |
This is the maximum observed plasma concentration of KZR-59587 (Cmax) observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The pharmacokinetic (PK) parameters were calculated using all timepoints at which the concentration was measured, ie. pre-dose and 30 minutes, and 4 hours post-dose, with an additional sample obtained at 0.25, 1, or 2 hours post-dose.
| ng/mL | Zetomipzomib (Arm A: Period 1) | Zetomipzomib (Arm B: Period 2) |
|---|---|---|
| PK of KZR-59587 (Cmax) | 48.2 ± 58.5 | 58.5 ± 46.4 |
This is the time to maximum observed plasma concentration of KZR-59587 (tmax) observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 30 minutes, and 4 hours postdose, with an additional sample obtained at 0.25, 1, or 2 hours postdose.
| hours | Zetomipzomib (Arm A: Period 1) | Zetomipzomib (Arm B: Period 2) |
|---|---|---|
| PK of KZR-59587 (Tmax) | 2.50 (0.52 to 4.02) | 3.92 (0.98 to 4.55) |
This is the area under the curve of KZR-59587 (AUC) from predose through 4 hour postdose observed after administration of the first dose of KZR-616 (either Week 0 or Week 16). The PK parameters were calculated using all timepoints at which the concentration was measured, ie. predose and 30 minutes, and 4 hours postdose, with an additional sample obtained at 0.25, 1, or 2 hours postdose.
| ng*h/mL | Zetomipzomib (Arm A: Period 1) | Zetomipzomib (Arm B: Period 2) |
|---|---|---|
| PK of KZR-59587 (AUC) | 150 ± 59.2 | 176 ± 53.3 |
Collected over Up to 40 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm A: Period 1 (Zetomipzomib) | 0/13 (0%) | 1/13 (7.7%) | 12/13 (92.3%) |
| Arm A: Period 2 (Placebo) | 0/10 (0%) | 0/10 (0%) | 8/10 (80%) |
| Arm B: Period 1 (Placebo) | 0/12 (0%) | 1/12 (8.3%) | 7/12 (58.3%) |
| Arm B: Period 2 (Zetomipzomib) | 0/12 (0%) | 1/12 (8.3%) | 10/12 (83.3%) |
| Event | Arm A: Period 1 (Zetomipzomib) | Arm A: Period 2 (Placebo) | Arm B: Period 1 (Placebo) | Arm B: Period 2 (Zetomipzomib) |
|---|---|---|---|---|
| Retinal detachmentEye disorders | 0/13 | 0/10 | 0/12 | 1/12 |
| COVID-19 pneumoniaInfections and infestations | 0/13 | 0/10 | 1/12 | 0/12 |
| FallInjury, poisoning and procedural complications | 1/13 | 0/10 | 0/12 | 0/12 |
| SyncopeNervous system disorders | 1/13 | 0/10 | 0/12 | 0/12 |
| Event | Arm A: Period 1 (Zetomipzomib) | Arm A: Period 2 (Placebo) | Arm B: Period 1 (Placebo) | Arm B: Period 2 (Zetomipzomib) |
|---|---|---|---|---|
| Injection site reactionGeneral disorders | 3/13 | 0/10 | 2/12 | 6/12 |
| Injection site painGeneral disorders | 6/13 | 0/10 | 1/12 | 2/12 |
| FatigueGeneral disorders | 5/13 | 0/10 | 0/12 | 1/12 |
| Injection site erythemaGeneral disorders | 5/13 | 0/10 | 0/12 | 2/12 |
| PainGeneral disorders | 4/13 | 0/10 | 0/12 | 0/12 |
| HeadacheNervous system disorders | 4/13 | 0/10 | 1/12 | 0/12 |
| Urinary tract infectionInfections and infestations | 2/13 | 0/10 | 3/12 | 1/12 |
| PruritusSkin and subcutaneous tissue disorders | 3/13 | 0/10 | 1/12 | 3/12 |
| NauseaGastrointestinal disorders | 3/13 | 1/10 | 1/12 | 0/12 |
| RashSkin and subcutaneous tissue disorders | 3/13 | 0/10 | 0/12 | 0/12 |
| Age, Continuous(years) | Zetomipzomib First, Then Placebo (Arm A) | Placebo First, Then Zetomipzomib (Arm B) | Total |
|---|---|---|---|
| Mean | 49.2 ± 10.7 | 54.3 ± 16.4 | 51.6 ± 13.7 |
| Sex: Female, Male(Participants) | Zetomipzomib First, Then Placebo (Arm A) | Placebo First, Then Zetomipzomib (Arm B) | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 3 | 4 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Zetomipzomib First, Then Placebo (Arm A) | Placebo First, Then Zetomipzomib (Arm B) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 10 | 9 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Zetomipzomib First, Then Placebo (Arm A) | Placebo First, Then Zetomipzomib (Arm B) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 5 | 10 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Physician Global Assessment (MDGA)(score on a scale) | Zetomipzomib First, Then Placebo (Arm A) | Placebo First, Then Zetomipzomib (Arm B) | Total |
|---|---|---|---|
| Mean | 5.1 ± 1.3 | 4.9 ± 1.6 | 5.0 ± 1.4 |
| Patient Global Assessment of Disease Activity (PtGADA)(score on a scale) | Zetomipzomib First, Then Placebo (Arm A) | Placebo First, Then Zetomipzomib (Arm B) | Total |
|---|---|---|---|
| Mean | 68.8 ± 20.5 | 58.6 ± 18.9 | 63.9 ± 20.0 |
| Manual Muscle Testing-8 Muscle Groups (MMT-8)(score on a scale) | Zetomipzomib First, Then Placebo (Arm A) | Placebo First, Then Zetomipzomib (Arm B) | Total |
|---|---|---|---|
| Mean | 124.2 ± 9.5 | 127.7 ± 6.5 | 125.9 ± 8.2 |
| Health Assessment Questionnaire - Disability (HAQ-DI)(score on a scale) | Zetomipzomib First, Then Placebo (Arm A) | Placebo First, Then Zetomipzomib (Arm B) | Total |
|---|---|---|---|
| Mean | 1.7 ± 0.9 | 1.2 ± 0.7 | 1.5 ± 0.8 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: KZR-616
Kezar Life Sciences, Inc.