A Study of Zetomipzomib (KZR-616) in Patients With Active... | NCT05781750

Label	Type	Description	Intervention Names
zetomipzomib 30 mg + standard-of-care	Experimental	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Drug: zetomipzomib
zetomipzomib 60 mg + standard-of-care	Experimental	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	Drug: zetomipzomib
placebo + standard-of-care	Placebo Comparator	Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
zetomipzomib	Drug	Subcutaneous injection of zetomipzomib	zetomipzomib 30 mg + standard-of-care zetomipzomib 60 mg + standard-of-care

Measure	Description	Time Frame
Proportion of Patients Achieving Complete Renal Response	Proportion of patients achieving complete renal response (CRR), defined as: A UPCR ≤0.5 in one 24-hour urine sample (for primary endpoint and Week 53) or 2 consecutive first morning void urine samples (for all other time points) An eGFR ≥60 mL/min/1.73 m^2 or no confirmed decrease of >20% from Baseline eGFR.	Week 37

Measure	Description	Time Frame
Proportion of Patients Achieving Partial Renal Response (PRR)	Proportion of patients achieving PRR, defined as a: ≥50% reduction of UPCR from Baseline, and to <1.0 if the Baseline UPCR was <3.0 or to <3.0 if the Baseline value was ≥3.0.	Week 25 and Week 37
Proportion of Patients Achieving Complete Renal Response

Name	Affiliation	Role
Kezar	Kezar Life Sciences, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Accurate Clinical Research - Lake Charles		Lake Charles	Louisiana	70605	United States
Nephrology Associates, Inc

Label	URL
Corporate website	View source

ID	Title	Description
FG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
FG001	Zetomipzomib 60 mg + Standard-of-care

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 27, 2023	Nov 7, 2025

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

Proportion of Patients Achieving Complete Renal Response

Proportion of patients achieving complete renal response (CRR), defined as:

A UPCR ≤0.5 in one 24-hour urine sample (for primary endpoint and Week 53) or 2 consecutive first morning void urine samples (for all other time points)
An eGFR ≥60 mL/min/1.73 m^2 or no confirmed decrease of >20% from Baseline eGFR.

Participants in the intent to treat analysis set who reached Week 37 of treatment. Intent-to-treat set was defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the 37 week timepoint for efficacy analysis.

Posted

Count of Participants

Participants

Week 37

ID	Title	Description
OG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG002	Placebo + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.

Units	Counts
Participants	OG0004 OG0016 OG0026

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011 OG0020

Secondary

Proportion of Patients Achieving Partial Renal Response (PRR)

Proportion of patients achieving PRR, defined as a:

≥50% reduction of UPCR from Baseline, and to <1.0 if the Baseline UPCR was <3.0 or to <3.0 if the Baseline value was ≥3.0.

Participants in the intent to treat set, defined as the set of all participants who are randomized to the study. This analysis focuses on the participants with Class III/IV ± Class V lupus nephritis. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.

Posted

Count of Participants

Participants

Week 25 and Week 37

ID	Title	Description
OG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG002	Placebo + Standard-of-care

Secondary

Proportion of Patients Achieving Complete Renal Response

Proportion of patients achieving complete renal response (CRR)

Posted

Count of Participants

Participants

Week 25

ID	Title	Description
OG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG002	Placebo + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.

Secondary

Change in UPCR

Percentage change from Baseline in Urine Protein to Creatinine Ratio (UPCR) by visit

Posted

Mean

Standard Deviation

percent change in 24-hr UPCR value

Week 13, Week 25, and Week 37

ID	Title	Description
OG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG002	Placebo + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.

Secondary

Time to Complete Renal Response and Partial Renal Response

The comparison of the time to Complete Renal Response and Partial Renal Response for the zetomipzomib treatment groups (zetomipzomib 30mg and zetomipzomib 60mg) versus placebo. Hazard ratio (HR) and associated two-sided CIs are estimated using the Cox proportional hazards model. The model includes terms for treatment, the randomization stratification factors, and baseline UPCR (continuous).

Posted

Mean

95% Confidence Interval

weeks

Baseline through Week 37

ID	Title	Description
OG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.

Secondary

Proportion of Patients With UPCR ≤0.5

Proportion of patients with UPCR ≤0.5

Posted

Count of Participants

Participants

Week 13, Week 25, and Week 37

ID	Title	Description
OG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG002	Placebo + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.

Secondary

Percent Change in the Systemic Lupus Erythematosus (SLE) Disease Activity Index 2000 (SLEDAI-2K)

Percent change from Baseline in clinical SLEDAI-2K score. The SLEDAI-2K score falls between 0 and 105. A higher score represents greater disease activity.

Posted

Mean

Standard Deviation

percent change of SLEDAI-2K score

Week 13, Week 25, and Week 37

ID	Title	Description
OG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG002	Placebo + Standard-of-care

Post-Hoc

Change in UPCR

Percentage change from Baseline in Urine Protein to Creatinine Ratio (UPCR) by visit

Participants in the intent to treat set defined as the participants with Class III/IV ± Class V lupus nephritis including the participant who was actually diagnosed as Class IV and was mistakenly stratified to Pure Class V. Due to the early termination of the study, not all participants reached the timepoints for efficacy analysis and no participants completed the full 52-week treatment period.

Posted

Mean

Standard Deviation

percent change in 24-hr UPCR value

Week 13, Week 25, and Week 37

ID	Title	Description
OG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG002	Placebo + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.

Post-Hoc

Proportion of Participants With UPCR ≤0.5

Posted

Count of Participants

Participants

Week 13, Week 25, and Week 37

ID	Title	Description
OG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
OG002	Placebo + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure	Cardiac disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Gastritis	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Nausea	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Chills	General disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Generalised oedema	General disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Pyrexia	General disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Dengue fever	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Gastroenteritis viral	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Herpes zoster	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Pneumonia	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Pneumonia bacterial	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Pseudomonas infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Urinary tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Injection related reaction	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Blood pressure increased	Investigations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0012 events2 affected29 at risk EG0020 events0 affected28 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Bipolar disorder	Psychiatric disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0021 events1 affected28 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Hypovolaemic shock	Vascular disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Lupus vasculitis	Vascular disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0012 events2 affected29 at risk EG0020 events0 affected28 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Tachycardia	Cardiac disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Ear pain	Ear and labyrinth disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Vertigo	Ear and labyrinth disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0017 events2 affected29 at risk EG0022 events1 affected28 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG00010 events5 affected27 at risk EG0019 events5 affected29 at risk EG0023 events3 affected28 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Flatulence	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Nausea	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG0006 events4 affected27 at risk EG00128 events8 affected29 at risk EG0021 events1 affected28 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 27.0	Systematic Assessment	EG00010 events2 affected27 at risk EG00128 events9 affected29 at risk EG0022 events2 affected28 at risk
Asthenia	General disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0012 events1 affected29 at risk EG0020 events0 affected28 at risk
Chest pain	General disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Chills	General disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG00119 events6 affected29 at risk EG0020 events0 affected28 at risk
Face oedema	General disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0016 events1 affected29 at risk EG0020 events0 affected28 at risk
Fatigue	General disorders	MedDRA version 27.0	Systematic Assessment	EG0003 events2 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Generalised oedema	General disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Injection site erythema	General disorders	MedDRA version 27.0	Systematic Assessment	EG0004 events1 affected27 at risk EG0011 events1 affected29 at risk EG0021 events1 affected28 at risk
Injection site pain	General disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0013 events2 affected29 at risk EG0020 events0 affected28 at risk
Injection site reaction	General disorders	MedDRA version 27.0	Systematic Assessment	EG00017 events4 affected27 at risk EG00125 events11 affected29 at risk EG0020 events0 affected28 at risk
Injection site urticaria	General disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Localised oedema	General disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0016 events1 affected29 at risk EG0020 events0 affected28 at risk
Oedema peripheral	General disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0011 events1 affected29 at risk EG0021 events1 affected28 at risk
Pain	General disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0016 events2 affected29 at risk EG0020 events0 affected28 at risk
Peripheral swelling	General disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Pyrexia	General disorders	MedDRA version 27.0	Systematic Assessment	EG00018 events6 affected27 at risk EG00135 events12 affected29 at risk EG0023 events2 affected28 at risk
Bronchitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Gastroenteritis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0013 events3 affected29 at risk EG0020 events0 affected28 at risk
Genital herpes zoster	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Herpes zoster	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0011 events1 affected29 at risk EG0022 events2 affected28 at risk
Influenza	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0022 events2 affected28 at risk
Laryngitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Nasal herpes	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Nasopharyngitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0017 events4 affected29 at risk EG0020 events0 affected28 at risk
Oral candidiasis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Otitis media	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Pneumonia	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Septic shock	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Sinusitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Skin infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0002 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Tinea infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Tonsillitis	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0006 events6 affected27 at risk EG0012 events2 affected29 at risk EG0021 events1 affected28 at risk
Urinary tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Viral infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Fall	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Blood bicarbonate decreased	Investigations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Blood cholesterol increased	Investigations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Blood pressure increased	Investigations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Blood uric acid increased	Investigations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Glomerular filtration rate decreased	Investigations	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Low density lipoprotein increased	Investigations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Mean cell haemoglobin concentration decreased	Investigations	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0012 events1 affected29 at risk EG0020 events0 affected28 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0012 events1 affected29 at risk EG0022 events1 affected28 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Dizziness	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0003 events2 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Headache	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG00012 events3 affected27 at risk EG00110 events4 affected29 at risk EG0023 events2 affected28 at risk
Lethargy	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0011 events1 affected29 at risk EG0021 events1 affected28 at risk
Paraparesis	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Syncope	Nervous system disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Antisocial personality disorder	Psychiatric disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Anxiety	Psychiatric disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Autism spectrum disorder	Psychiatric disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Bipolar disorder	Psychiatric disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Psychotic disorder	Psychiatric disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Dysuria	Renal and urinary disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0013 events3 affected29 at risk EG0020 events0 affected28 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Heavy menstrual bleeding	Reproductive system and breast disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0023 events1 affected28 at risk
Menstruation irregular	Reproductive system and breast disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0015 events4 affected29 at risk EG0021 events1 affected28 at risk
Hypersensitivity pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0010 events0 affected29 at risk EG0021 events1 affected28 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0012 events2 affected29 at risk EG0020 events0 affected28 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Post inflammatory pigmentation change	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0015 events1 affected29 at risk EG0022 events2 affected28 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0001 events1 affected27 at risk EG0010 events0 affected29 at risk EG0020 events0 affected28 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA version 27.0	Systematic Assessment	EG0002 events1 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Hypertension	Vascular disorders	MedDRA version 27.0	Systematic Assessment	EG0004 events2 affected27 at risk EG0011 events1 affected29 at risk EG0020 events0 affected28 at risk
Hypotension	Vascular disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0011 events1 affected29 at risk EG0022 events2 affected28 at risk
Peripheral coldness	Vascular disorders	MedDRA version 27.0	Systematic Assessment	EG0000 events0 affected27 at risk EG0012 events1 affected29 at risk EG0020 events0 affected28 at risk

ID	Term
D008181	Lupus Nephritis
D008180	Lupus Erythematosus, Systemic

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	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

ID	Title	Description
BG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
BG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.
BG002	Placebo + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Zetomipzomib 30 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 30 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	2	27	5	27	23	27
EG001	Zetomipzomib 60 mg + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of zetomipzomib, followed by weekly doses of 60 mg zetomipzomib through the treatment period in addition to background standard of care therapy.	1	29	8	29	25	29
EG002	Placebo + Standard-of-care	Participants randomized to be treated with initial 30 mg dose of placebo, followed by weekly doses (30 mg or 60 mg) of placebo through the treatment period in addition to background standard of care therapy.	1	28	3	28	17	28