A Study of KZR-616 in Patients With SLE With and Without... | NCT03393013 | Trialant
NCT03393013
Sponsor
Kezar Life Sciences, Inc.
Status
Completed
Last Update Posted
Nov 18, 2025Actual
Enrollment
69Actual
Phase
Phase 1Phase 2
Conditions
Lupus Nephritis
Systemic Lupus Erythematosus
Interventions
KZR-616
Countries
United States
Australia
Colombia
Mexico
Peru
Poland
Russia
Ukraine
Protocol Section
Identification Module
NCT ID
NCT03393013
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
KZR-616-002
Secondary IDs
Not provided
Brief Title
A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis
Official Title
A Phase 1b/2 Study of KZR-616 in Patients With Systemic Lupus Erythematosus With and Without Nephritis (MISSION)
Acronym
MISSION
Organization
Kezar Life Sciences, Inc.INDUSTRY
Status Module
Record Verification Date
Nov 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 20, 2018Actual
Primary Completion Date
Aug 4, 2022Actual
Completion Date
Aug 4, 2022Actual
First Submitted Date
Dec 21, 2017
First Submission Date that Met QC Criteria
Jan 4, 2018
First Posted Date
Jan 8, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Nov 21, 2023
Results First Submitted that Met QC Criteria
Mar 7, 2024
Results First Posted Date
Mar 8, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 12, 2025
Last Update Posted Date
Nov 18, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Kezar Life Sciences, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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).
Detailed Description
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:
Cohort 3: zetomipzomib lyophile, 30 mg weekly × 1 week, followed by 75 mg weekly × 12 weeks
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).
Conditions Module
Conditions
Lupus Nephritis
Systemic Lupus Erythematosus
Keywords
immunoproteasome inhibition
selective proteasome inhibition
proteasome
lupus nephritis
lupus
nephritis
active proliferative lupus nephritis
open-label
systemic lupus erythematosus
lupus erythematosus
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
69Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
KZR-616 45 mg + standard of care therapy (Phase 1b)
Experimental
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
KZR-616 60 mg + standard of care therapy (Phase 1b)
Experimental
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
KZR-616 75 mg + standard of care therapy (Phase 1b)
Experimental
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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
KZR-616
Drug
Subcutaneous Injection of KZR-616
KZR-616 45 mg + standard of care therapy (Phase 1b)
KZR-616 60 mg + standard of care therapy (Phase 1b)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
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.
24 weeks
Secondary Outcomes
Measure
Description
Time Frame
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.
8 hours
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Phase 1b:
Fulfilled the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification for SLE
Had a positive antinuclear antibody (ANA) titer, anti-double stranded DNA (dsDNA) antibody titer, or a positive anti-Smith antibody titer
Had active SLE (as indicated by Systemic Lupus Erythematosus Disease Activity Index 2000 [SLEDAI-2K] score ≥4), and
Had received at least 1 prior therapy for SLE
Phase 2:
Had active proliferative LN (Class III or IV, with or without Class V disease)
Had a UPCR ≥1.0 measured in 24-hour urine collection
Had a histologic diagnosis of LN on renal biopsy within the prior 2 years; for biopsies > 1 year before the Screening visit, one of the following must also be present at screening: low C3, low C4, or anti-ds-DNA elevated to above normal range
Fulfilled the 2012 SLICC classification for SLE
Had a positive ANA titer, anti-dsDNA antibody titer, or anti-Smith antibody titer, and
Were currently receiving ≥1 immunosuppressive agent at a stable dose and route of administration for ≥8 weeks. If the patient is also on corticosteroids then must be on a stable dose for ≥ 2 weeks prior to Baseline
Key Exclusion Criteria:
Phase 1b:
Current or medical history of:
Central nervous system manifestations by autoimmune disease
Overlapping autoimmune condition that may affect study assessments/outcomes
Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening
Malignancy of any type, with exceptions for in situ cancer that has been completely excised and certain cancers >5 years ago
Positive test at Screening for HIV, hepatitis B/C
Major surgery within 4 weeks before signing informed consent form or planned major surgery during the study period
Phase 2:
Current or medical history of:
Central nervous system manifestations of SLE
Overlapping autoimmune condition that may affect study assessments/outcomes
Antiphospholipid syndrome with history of thromboembolic event of within the 52 weeks prior to Screening
Malignancy of any type within the last 5 years, with exceptions for appropriately excised and cured cervical carcinoma in situ or excised basal or squamous cell carcinomas of the skin
Has received dialysis within the 52 weeks prior to Screening
Positive test at Screening for HIV, hepatitis B/C
Major surgery within 12 weeks before signing informed consent form or planned major surgery during the study period
Use of investigational therapy or device, and/or participation in an investigational trial <8 weeks or 5 half-lives, whichever is longer, prior to Baseline; Patients who participated in Phase 1b of KZR-616-002 are excluded from Phase 2
Avasare R, Drexler Y, Caster DJ, Mitrofanova A, Jefferson JA. Management of Lupus Nephritis: New Treatments and Updated Guidelines. Kidney360. 2023 Oct 1;4(10):1503-1511. doi: 10.34067/KID.0000000000000230.
Patients who were enrolled in Phase 1b were ineligible to enroll in the Phase 2 portion of the study.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy.
KZR-616: Subcutaneous Injection of KZR-616
FG001
Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b)
Periods
Title
Milestones
Reasons Not Completed
Phase 1b
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Jul 7, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Drug: KZR-616
KZR-616 60 mg + standard therapy (Phase 2)
Experimental
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
KZR-616 60 mg + standard therapy (Phase 2)
KZR-616 75 mg + standard of care therapy (Phase 1b)
zetomipzomib
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.
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.
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:
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))
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%
No use of prohibited medication
Count of patients below includes those who satisfy all three of the above criteria.
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.
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.
25 weeks
Upland
California
91786
United States
SouthCoast Research Center, Inc.
Miami
Florida
33136
United States
Hope Clinical Trials, Inc.
Miami
Florida
33165
United States
Omega Research Maitland
Orlando
Florida
32808
United States
Arthritis Center, Inc
Palm Harbor
Florida
34684
United States
Advent Health Medical Group
Tampa
Florida
33614
United States
University of Iowa
Iowa City
Iowa
52242
United States
Northwell Health
Great Neck
New York
11021
United States
NYU Langone Orthopedic Center - Seligman Center for Advanced Therapeutics
New York
New York
10016
United States
University of Rochester Medical Center
Rochester
New York
14620
United States
The Ohio State University Wexner Medical Center
Columbus
Ohio
43210
United States
SC Nephrology & Hypertension Center, Inc.
Orangeburg
South Carolina
29118
United States
Ramesh C. Gupta, MD
Memphis
Tennessee
38119
United States
MedResearch, Inc.
El Paso
Texas
79902
United States
Accurate Clinical Research, Inc.
Houston
Texas
77034
United States
Accurate Clinical Management, LLC
Houston
Texas
77084
United States
Monash Health
Clayton
Victoria
3168
Australia
The Royal Melbourne Hospital
Parkville
Victoria
3050
Australia
Centro Integral de Reumatologia de Caribe CIRCARIBE S.A.S
Centro de Investigación ClÃnica Trujillo E.I.R.L/ ClÃnica Peruano Americana S.A.
Trujillo
La Libertad
13011
Peru
Investigaciones Clinicas SAC
Lima
15023
Peru
Unidad de Investigacion en Reumatologia e Inmunologia Clinica San Juan Bautista
Lima
15431
Peru
Bioclinica
Lodz
90-368
Poland
Kuzbass Clinical Hospital
Kemerovo
650066
Russia
Medical Center Revma-Med
Kemerovo
650070
Russia
Tolyatti City Clinical Hospital #1
Tolyatti
445009
Russia
Harmoniya Krasy
Kyiv
Kyiv Governorate
01135
Ukraine
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
FG002
Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
FG003
Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
FG004
Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses.
KZR-616: Subcutaneous Injection of KZR-616
FG005
Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
FG006
KZR-616 QW, 60 mg + SOC (Phase 2)
KZR-616 was administered as a subcutaneous injection QW for 24 weeks (including an initial Week 1 dose of 30 mg).
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 SOC therapy including at least one immunosuppressive agent.
KZR-616: Subcutaneous Injection of KZR-616
*See Limitations/Caveats for additional information
FG0008 subjects
FG0015 subjects
FG00214 subjects
FG0036 subjects
FG0048 subjects
FG0056 subjects
FG0060 subjects
COMPLETED
FG0005 subjects
FG0012 subjects
FG00210 subjects
FG0036 subjects
FG0048 subjects
FG0054 subjects
FG0060 subjects
NOT COMPLETED
FG0003 subjects
FG0013 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
FG0052 subjects
FG0060 subjects
Phase 2
Type
Comment
Milestone Data
STARTED
Patients who were in Cohorts 1, 2, 2a, 2b, 2c, and 3 were enrolled in Phase 1b only.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG00622 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy.
KZR-616: Subcutaneous Injection of KZR-616
BG001
Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
BG002
Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
BG003
Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
BG004
Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses.
KZR-616: Subcutaneous Injection of KZR-616
BG005
Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
BG006
KZR-616 QW, 60 mg + SOC (Phase 2)
KZR-616 was administered as a subcutaneous injection QW for 24 weeks (including an initial Week 1 dose of 30 mg).
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 SOC therapy including at least one immunosuppressive agent.
KZR-616: Subcutaneous Injection of KZR-616
*See Limitations/Caveats for additional information
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0015
BG00214
BG0036
BG0048
BG0056
BG00622
BG00769
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG0008
ParticipantsBG0015
ParticipantsBG00214
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0008
ParticipantsBG0015
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0008
ParticipantsBG0015
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0008
ParticipantsBG0015
ParticipantsBG002
UPCR at Baseline
UPCR = urine protein to creatinine ratio
For Phase 1b only, UPCR was measured in g/g.
This baseline metric was measured for all patients in Phase 2. For Phase 1b, only two patients had active lupus nephritis with significant proteinuria.
Mean
Standard Deviation
mg/mg
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
eGFR Level at Baseline
eGFR = estimated glomerular filtration rate
This baseline metric was only measured for patients in Phase 2. Additionally, this baseline metric is not available for one patient from Phase 2 who was enrolled in an earlier protocol amendment.
** See Limitations/Caveat Section
Mean
Standard Deviation
mL/min/1.73 m^2
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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.
Posted
Count of Participants
Participants
25 weeks
ID
Title
Description
OG000
Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy.
KZR-616: Subcutaneous Injection of KZR-616
OG001
Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
OG002
Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
OG003
Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
OG004
Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses.
KZR-616: Subcutaneous Injection of KZR-616
OG005
Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
Units
Counts
Participants
OG0008
OG0015
OG00214
OG003
Title
Denominators
Categories
Title
Measurements
OG0007
OG0015
OG00211
OG003
Primary
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.
Outcome only measured for Phase 2.
One patient is excluded (N=21) due to enrollment under an earlier Protocol Amendment.
Prior to the open-label design, 1 patient was enrolled in Phase 2. Efficacy data for this patient are not included in this analysis because the patient received zetomipzomib for a shorter time duration (13 weeks) than specified by the outcome measure.
*See Limitations and Caveats section for more information
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
KZR-616 QW, 60 mg + SOC (Phase 2)
KZR-616 was administered as a subcutaneous injection QW for 24 weeks (including an initial Week 1 dose of 30 mg).
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 SOC therapy including at least one immunosuppressive agent.
KZR-616: Subcutaneous Injection of KZR-616
*See Limitations/Caveats for additional information
Units
Counts
Participants
Secondary
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.
This outcome was only measured in Phase 1b. The PK population is different than the overall studied population. As is pre-specified in the study protocol, analysis was completed per dose/treatment instead of per cohort for PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
8 hours
ID
Title
Description
OG000
KZR-616 30 mg + Standard of Care Therapy
Although there was no 30 mg dose group planned for phase 1b, an arm was included for those patients that only received 30 mg as a step up dose.
Four Phase 1b cohorts (Cohorts 2a, 2b, 2c, and 3) received 30 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
OG001
KZR-616 45 mg + Standard of Care Therapy (Phase 1b)
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 (Cohorts 1 and 2a) received 45 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
KZR-616: Subcutaneous Injection of KZR-616
Secondary
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.
This outcome was only measured in Phase 1b. The PK population is different than the overall studied population. As is pre-specified in the study protocol, analysis was completed per dose/treatment instead of per cohort for PK data.
Posted
Median
Full Range
hours
8 hours
ID
Title
Description
OG000
KZR-616 30 mg + Standard of Care Therapy
Although there was no 30 mg dose group planned for phase 1b, an arm was included for those patients that only received 30 mg as a step up dose.
Four Phase 1b cohorts (Cohorts 2a, 2b, 2c, and 3) received 30 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
OG001
KZR-616 45 mg + Standard of Care Therapy (Phase 1b)
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 (Cohorts 1 and 2a) received 45 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
KZR-616: Subcutaneous Injection of KZR-616
Secondary
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.
This outcome was only measured in Phase 1b. The PK population is different than the overall studied population. As is pre-specified in the study protocol, analysis was completed per dose/treatment instead of per cohort for PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*h/ml
8 hours
ID
Title
Description
OG000
KZR-616 30 mg + Standard of Care Therapy
Although there was no 30 mg dose group planned for phase 1b, an arm was included for those patients that only received 30 mg as a step up dose.
Four Phase 1b cohorts (Cohorts 2a, 2b, 2c, and 3) received 30 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
OG001
KZR-616 45 mg + Standard of Care Therapy (Phase 1b)
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 (Cohorts 1 and 2a) received 45 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
KZR-616: Subcutaneous Injection of KZR-616
Secondary
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:
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))
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%
No use of prohibited medication
Count of patients below includes those who satisfy all three of the above criteria.
Outcome only measured for Phase 2.
One patient is excluded (N=21) due to enrollment under an earlier Protocol Amendment.
Prior to the open-label design, 1 patient was enrolled in Phase 2. Efficacy data for this patient are not included in this analysis because the patient received zetomipzomib for a shorter time duration (13 weeks) than specified by the outcome measure.
*See Limitations and Caveats section for more information
Posted
Count of Participants
Participants
24 weeks
ID
Title
Description
OG000
KZR-616 QW, 60 mg + SOC (Phase 2)
KZR-616 was administered as a subcutaneous injection QW for 24 weeks (including an initial Week 1 dose of 30 mg).
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 SOC therapy including at least one immunosuppressive agent.
KZR-616: Subcutaneous Injection of KZR-616
*See Limitations/Caveats for additional information
Secondary
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.
This outcome measure was only analyzed for Phase 2.
Posted
Number
events per person-weeks
37 weeks
Number of exposures
Number of exposures
ID
Title
Description
OG000
KZR-616 QW, 60 mg + SOC (Phase 2)
KZR-616 was administered as a subcutaneous injection QW for 24 weeks (including an initial Week 1 dose of 30 mg).
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 SOC therapy including at least one immunosuppressive agent.
KZR-616: Subcutaneous Injection of KZR-616
*See Limitations/Caveats for additional information
Units
Counts
Participants
OG000
Secondary
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.
The DMC reviewed cumulative Phase 1b study data and provided a recommendation for the Phase 2 dose.
Posted
Number
mg
25 weeks
ID
Title
Description
OG000
All Phase 1b Patients (Cohort 1, Cohort 2a-c, Cohort 3)
The DMC reviewed the data of the Phase 1b patient population. These patients received varying doses (30, 45, 60, or 75 mg) of KZR-616 depending on their study cohort and whether their cohort had a step-up dosing procedure included.
KZR-616: Subcutaneous Injection of KZR-616
Units
Counts
Participants
OG000
Post-Hoc
Phase 1b: Changes in UPCR in Patients With SLE Who Had Active Lupus Nephritis
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)
Only two patients in the Phase 1b study had active lupus nephritis.
Posted
Number
g/g
Week 25
ID
Title
Description
OG000
Patient 1
Enrolled in Cohort 2a where participants received 13 weeks of KZR-616:
- 2 weeks of 30 mg, followed by 2 weeks of 45 mg, and 9 weeks of 60 mg
OG001
Patient 2
Enrolled in Cohort 2c where participants received 13 weeks of KZR-616:
- 1 week of 30 mg and then 12 weeks of 60 mg
Units
Counts
Participants
OG000
Time Frame
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.
Description
Anticipated fluctuations of pre-existing conditions, including the disease under study, that do not represent a clinically significant exacerbation or worsening need not be considered AEs.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1, KZR-616 QW, 45 mg + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 45 mg once weekly (QW) for 13 weeks in combination with standard of care (SOC) therapy.
KZR-616: Subcutaneous Injection of KZR-616
0
8
0
8
8
8
EG001
Cohort 2, KZR-616 QW, 60 mg + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW for 13 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
0
5
1
5
5
5
EG002
Cohort 2a, KZR-616 QW, 30 mg x 2 Wks, 45 mg x 2 Wks, 60 mg x 9 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 30 mg QW for 2 weeks, 45 mg QW for 2 weeks, and then 60 mg QW for 9 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
0
14
2
14
12
14
EG003
Cohort 2b, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
0
6
1
6
4
6
EG004
Cohort 2c, KZR-616 QW, 30 mg x 1 wk, 60 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 60 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
This cohort was the tolerability strategy cohort, which introduced prophylactic measures of hydration with an oral electrolyte and non-sedating antihistamines for the first two doses.
KZR-616: Subcutaneous Injection of KZR-616
0
8
0
8
7
8
EG005
Cohort 3, KZR-616 QW, 30 mg x 1 wk, 75 mg x 12 Wks + SOC (Phase 1b)
Dose escalation cohort of patients with SLE with and without nephritis to receive KZR-616 75 mg QW (following an initial Week 1 dose of 30 mg) for 12 weeks in combination with SOC therapy.
KZR-616: Subcutaneous Injection of KZR-616
0
6
0
6
3
6
EG006
KZR-616 QW, 60 mg + SOC (Phase 2)
KZR-616 was administered as a subcutaneous injection QW for 24 weeks (including an initial Week 1 dose of 30 mg).
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 SOC therapy including at least one immunosuppressive agent.
KZR-616: Subcutaneous Injection of KZR-616
*See Limitations/Caveats for additional information
0
22
2
22
22
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thrombotic microangiopathy
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected22 at risk
Systemic inflammatory response syndrome
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Herpes zoster
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Viral infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Migraine
Nervous system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Acute kidney injury
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected6 at risk
EG0061 events1 affected22 at risk
Haemolytic anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Lymphopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Normochromic normocytic anaemia
Blood and lymphatic system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Tachycardia
Cardiac disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Developmental hip dysplasia
Congenital, familial and genetic disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Ear pain
Ear and labyrinth disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Cataract nuclear
Eye disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Conjunctival haemorrhage
Eye disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Dry eye
Eye disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Eyelid oedema
Eye disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Periorbital oedema
Eye disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Photophobia
Eye disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Scleritis
Eye disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal distension
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Acid peptic disease
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Dry mouth
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Frequent bowel movements
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Lip swelling
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Lip ulceration
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0002 events2 affected8 at risk
EG0016 events4 affected5 at risk
EG0028 events5 affected14 at risk
EG003
Odynophagia
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Oral pain
Gastrointestinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Vomiting
Gastrointestinal disorders
Systematic Assessment
EG0001 events1 affected8 at risk
EG0017 events5 affected5 at risk
EG0026 events3 affected14 at risk
EG003
Asthenia
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Chest pain
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Chills
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0022 events1 affected14 at risk
EG003
Fatigue
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Feeling cold
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Generalised oedema
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Influenza like illness
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Injection site bruising
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected14 at risk
EG003
Injection site discolouration
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG00110 events1 affected5 at risk
EG0024 events1 affected14 at risk
EG003
Injection site erythema
General disorders
Systematic Assessment
EG00030 events5 affected8 at risk
EG0017 events2 affected5 at risk
EG00216 events5 affected14 at risk
EG003
Injection site extravasation
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Injection site haemorrhage
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Injection site indentation
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Injection site induration
General disorders
Systematic Assessment
EG0002 events1 affected8 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Injection site mass
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Injection site nodule
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0023 events2 affected14 at risk
EG003
Injection site pain
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG00211 events4 affected14 at risk
EG003
Injection site pruritus
General disorders
Systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Injection site rash
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Injection site reaction
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Injection site swelling
General disorders
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0027 events2 affected14 at risk
EG003
Oedema peripheral
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Pain
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Peripheral swelling
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Puncture site pain
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0012 events2 affected5 at risk
EG00210 events3 affected14 at risk
EG003
Swelling
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Thirst
General disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Selective IgG subclass deficiency
Immune system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Bacterial vaginosis
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Body tinea
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Bronchitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Clostridium difficile infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Conjunctivitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Corona virus infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Gastroenteritis Escherichia coli
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Herpes zoster
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Hordeolum
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Laryngitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Nasopharyngitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Oral candidiasis
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Otitis externa
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Pharyngitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Pyelonephritis
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Skin candida
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Upper respiratory tract infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Urinary tract infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Contusion
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Post vaccination syndrome
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Amylase increased
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Blood creatine phosphokinase increased
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Blood triglycerides increased
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Body temperature increased
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Differential white blood cell count abnormal
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Electrocardiogram PR prolongation
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Electrocardiogram abnormal
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Lipase increased
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Protein urine present
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Reticulocyte count increased
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
White blood cell count decreased
Investigations
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Metabolic acidosis
Metabolism and nutrition disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0029 events1 affected14 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Chondritis
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Rib deformity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Dizziness
Nervous system disorders
Systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Headache
Nervous system disorders
Systematic Assessment
EG0001 events1 affected8 at risk
EG00113 events2 affected5 at risk
EG0029 events3 affected14 at risk
EG003
Hypoaesthesia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Lethargy
Nervous system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Migraine
Nervous system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Migraine with aura
Nervous system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Paraesthesia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Somnolence
Nervous system disorders
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Depression
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Mental status changes
Psychiatric disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Acute kidney injury
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Pelvic cyst
Reproductive system and breast disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Pulmonary hypertension
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Blister
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Butterfly rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Cutaneous lupus erythematosus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Hidradenitis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Lipohypertrophy
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Photosensitivity reaction
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Skin fissures
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Skin induration
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Systemic lupus erythematosus rash
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected14 at risk
EG003
Hot flush
Vascular disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Hypertension
Vascular disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
Hypotension
Vascular disorders
Systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected14 at risk
EG003
In Phase 2, of note, prior to the adoption of the open-label study design to improve enrollment after the onset of the COVID-19 pandemic, 1 patient with active proliferative LN was enrolled in Phase 2 under the earlier randomized, placebo-controlled, double-blind design. This patient was randomized to zetomipzomib at a dose of 30 mg SC weekly for 13 weeks and completed 12 of 13 dose administrations and all protocol-required procedures.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
PI shall have the right to publish or present their own data resulting from the Study ("Publication") upon the earlier of: (a) the date following a multicenter publication coordinated by Sponsor regarding the Protocol; (b) 12 months after completion of the Protocol by all sites; or (c) the date after submission of the Study Data by Sponsor to the FDA.
The PI must furnish Sponsor with a copy of any Publication at least 30 days in advance of the proposed submission or presentation date.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D052801
Male Urogenital Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000712054
KZR-616
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG00618 subjects
0 subjects
FG0050 subjects
FG0064 subjects
6
ParticipantsBG0048
ParticipantsBG0056
ParticipantsBG00622
ParticipantsBG00769
Title
Measurements
BG00051.9± 11.5
BG00146.2± 11.3
BG00253.6± 15.3
BG00354.3± 14.8
BG00448.1± 10.3
BG00545.0± 17.5
BG00634.6± 11.7
BG00745.5± 14.9
14
ParticipantsBG0036
ParticipantsBG0048
ParticipantsBG0056
ParticipantsBG00622
ParticipantsBG00769
Title
Measurements
Female
BG0008
BG0015
BG00212
BG0036
BG0048
BG0056
BG00620
BG00765
Male
BG0000
BG0010
BG0022
BG0030
BG004
14
ParticipantsBG0036
ParticipantsBG0048
ParticipantsBG0056
ParticipantsBG00622
ParticipantsBG00769
Title
Measurements
Hispanic or Latino
BG0004
BG0013
BG00210
BG0032
BG0045
BG0053
BG00612
BG00739
Not Hispanic or Latino
BG0004
BG0012
BG0024
BG0034
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
14
ParticipantsBG0036
ParticipantsBG0048
ParticipantsBG0056
ParticipantsBG00622
ParticipantsBG00769
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0064
BG0074
Asian
BG0000
BG0010
BG0021
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0001
BG0012
BG0021
BG0032
BG004
White
BG0007
BG0013
BG00212
BG0034
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
1
ParticipantsBG0030
ParticipantsBG0041
ParticipantsBG0050
ParticipantsBG00622
ParticipantsBG00724
Title
Measurements
BG0023.85
BG0042.39
BG0062.50± 2.56
BG0072.55± 2.46
0
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG00621
ParticipantsBG00721
Title
Measurements
BG006104.71± 32.579
BG007104.71± 32.579
6
OG0048
OG0056
3
OG0046
OG0053
OG00021
Title
Denominators
Categories
Title
Measurements
OG00011
OG002
KZR-616 60 mg + Standard of Care Therapy (Phase 1b)
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 (Cohorts 2, 2a, 2b, and 2c) received 60 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
KZR-616: Subcutaneous Injection of KZR-616
OG003
KZR-616 75 mg + Standard of Care Therapy (Phase 1b)
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 (Cohort 3) received 75 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
KZR-616: Subcutaneous Injection of KZR-616
Units
Counts
Participants
OG0001
OG0019
OG00220
OG0034
Title
Denominators
Categories
Title
Measurements
OG00074.2
OG001134± 45.6
OG002151± 50.3
OG003265± 60.4
OG002
KZR-616 60 mg + Standard of Care Therapy (Phase 1b)
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 (Cohorts 2, 2a, 2b, and 2c) received 60 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
KZR-616: Subcutaneous Injection of KZR-616
OG003
KZR-616 75 mg + Standard of Care Therapy (Phase 1b)
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 (Cohort 3) received 75 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
KZR-616: Subcutaneous Injection of KZR-616
Units
Counts
Participants
OG0001
OG0019
OG00220
OG0034
Title
Denominators
Categories
Title
Measurements
OG0001.00
OG0010.25(0.13 to 1.00)
OG0020.25(0.08 to 2.00)
OG0030.50(0.25 to 0.52)
OG002
KZR-616 60 mg + Standard of Care Therapy (Phase 1b)
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 (Cohorts 2, 2a, 2b, and 2c) received 60 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.
KZR-616: Subcutaneous Injection of KZR-616
OG003
KZR-616 75 mg + Standard of Care Therapy (Phase 1b)
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 (Cohort 3) received 75 mg of KZR-616 at some point during the study.
Dose level groups are determined based on last dose received.