A Study of Zetomipzomib (KZR-616) in Patients With Autoim... | NCT05569759

Label	Type	Description	Intervention Names
zetomipzomib + standard-of-care (glucocorticoids)	Experimental	Initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period.	Drug: zetomipzomib
placebo + standard-of-care (glucocorticoids)	Placebo Comparator	Initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period.	Drug: placebo
zetomipzomib + standard-of care (glucocorticoids) open-label extension period	Experimental	Initial 30 mg dose of zetomipzomib at the open-label extension (OLE) Week 1 visit, followed by weekly doses of 60 mg of zetomipzomib, for up to a total of 24 additional weeks of treatment.	Drug: zetomipzomib in open-label extension

Name	Type	Description	Arm Group Labels	Other Names
zetomipzomib	Drug	Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly	zetomipzomib + standard-of-care (glucocorticoids)

Measure	Description	Time Frame
Patients Who Achieved Complete Biochemical Response	The number of patients who achieve complete biochemical response (CR), defined as normal ALT, AST, and IgG values (if IgG level is elevated at Baseline) with glucocorticoid dose not higher than starting dose (at Baseline), by Week 24 of the Double-Blind Treatment Period. Analyses were also conducted at Week 12, Week 16, and Week 20.	Week 12, Week 16, Week 20, and Week 24
The Safety and Tolerability of Zetomipzomib	Proportion of participants who experience AEs (adverse events) and SAEs (serious adverse events) during the double-blind treatment period (DBTP) and the open-label extension (OLE).	Baseline through end of study visit (DBTP, Week 28 and OLE, Up to Week 24)
Proportion of Participants Experiencing a Disease Flare Among the Participants Who Achieved a CR During the Double-blind Treatment Period	Proportion of participants experiencing a disease flare among the participants who achieved a complete biochemical response (CR) during the double-blind treatment period.	Start of open-label extension (OLE) period through End of Study (EOS) up to OLE Week 25

Measure	Description	Time Frame
Alanine Aminotransferase (ALT)	Changes from baseline in alanine aminotransferase (ALT) during the double-blind treatment period.	Weeks 12, 16, 20, and 24
Partial Response	Proportion of participants who achieved a partial response (PR) during the double-blind treatment period of the study.

Measure	Description	Time Frame
Change From Baseline in Glucocorticoid Dose	Mean change from Baseline in glucocorticoid dose for participants during the double-blind treatment period at Weeks 12, 16, 20 and 24	Weeks 12, 16, 20, and 24

Name	Affiliation	Role
Craig Lammert, MD	Indiana University	Principal Investigator
Ethan Weinberg, MD	University of Pennsylvania	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona		Phoenix	Arizona	85054	United States
Keck School of Medicine of USC

Label	URL
Corporate website	View source

ID	Title	Description
FG000	Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care. Participants who completed the double blind treatment period could elect to continue in the open-label extension (OLE) period of the study. Participants who enrolled in the OLE period received an initial 30 mg dose of zetomipzomib at the open-label extension (OLE) Week 1 visit, followed by weekly doses of 60 mg of zetomipzomib in addition to standard of care, for up to a total of 24 additional weeks of treatment. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 26, 2024	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

Patients Who Achieved Complete Biochemical Response

The number of patients who achieve complete biochemical response (CR), defined as normal ALT, AST, and IgG values (if IgG level is elevated at Baseline) with glucocorticoid dose not higher than starting dose (at Baseline), by Week 24 of the Double-Blind Treatment Period. Analyses were also conducted at Week 12, Week 16, and Week 20.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Count of Participants

Participants

Week 12, Week 16, Week 20, and Week 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units	Counts
Participants	OG00016 OG0018

Title

Denominators

Categories

Week 12

Title	Measurements
	OG0006 OG0013

Week 16

Title	Measurements
	OG000

Primary

The Safety and Tolerability of Zetomipzomib

Proportion of participants who experience AEs (adverse events) and SAEs (serious adverse events) during the double-blind treatment period (DBTP) and the open-label extension (OLE).

The Safety Set (N=23) includes all participants who received at least one dose of IMP and were analyzed as randomized to treatment.

Posted

Number

participants

Baseline through end of study visit (DBTP, Week 28 and OLE, Up to Week 24)

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the double-blind treatment period in addition to standard of care. zetomipzomib in the double-blind treatment period: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the double-blind treatment period in addition to standard of care. placebo in the double-blind treatment period: Subcutaneous injection of placebo
OG002	Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP)

Primary

Proportion of Participants Experiencing a Disease Flare Among the Participants Who Achieved a CR During the Double-blind Treatment Period

Proportion of participants experiencing a disease flare among the participants who achieved a complete biochemical response (CR) during the double-blind treatment period.

Participants who enrolled in the optional open-label extension following their completion of the double-blind treatment period of the study and achieved a complete response during the double-blind treatment period.

Posted

Number

95% Confidence Interval

participants

Start of open-label extension (OLE) period through End of Study (EOS) up to OLE Week 25

ID	Title	Description
OG000	Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP)	Participants, who received zetomipzomib in the double-blind treatment period (DBTP) and enrolled in the open-label extension period, received an initial 30 mg dose of zetomipzomib at the open-label extension (OLE) Week 1 visit, followed by weekly doses of 60 mg of zetomipzomib, for up to a total of 24 additional weeks of treatment in addition to standard of care. zetomipzomib in open-label extension who received zetomipzomib during the double-blind treatment period: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP)	Participants, who received placebo in the double-blind treatment period (DBTP) and enrolled in the open-label extension period, received an initial 30 mg dose of zetomipzomib at the open-label extension (OLE) Week 1 visit, followed by weekly doses of 60 mg of zetomipzomib, for up to a total of 24 additional weeks of treatment in addition to standard of care. zetomipzomib in open-label extension who received placebo during the double-blind treatment period: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly

Secondary

Alanine Aminotransferase (ALT)

Changes from baseline in alanine aminotransferase (ALT) during the double-blind treatment period.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Mean

Standard Deviation

U/L

Weeks 12, 16, 20, and 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units	Counts
Participants

Secondary

Partial Response

Proportion of participants who achieved a partial response (PR) during the double-blind treatment period of the study.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Count of Participants

Participants

Weeks 12, 16, 20, and 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units	Counts
Participants

Secondary

Time to Complete Response

Time to complete response (CR), defined as the duration from first dose of study drug (zetomipzomib or placebo) to first CR, during the double-blind treatment period was measured using the Kaplan-Meier method. Due to the small sample size, not enough events of participants achieving CR were observed to provide Kaplan-Meier estimates for the 25th percentile, median, and 75th percentile time to CR.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Median

95% Confidence Interval

weeks

Baseline through Week 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Secondary

Disease Flare After CR

Proportion of participants who experienced a disease flare after complete response (CR) during the double-blind treatment period.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units	Counts
Participants

Secondary

Treatment Failures

Proportion of participants who were considered treatment failures, defined as ALT or AST level worsened ≥2 times that of the Baseline value that is sustained for ≥1 week as verified via repeat laboratory assessments, despite compliance with standard of care (ie, with regard to inclusion criteria) or protocol-defined therapy or a glucocorticoid dose is increased above the Baseline dose, it may be considered a treatment failure unless attributed to an adverse event not relating to AIH, during the double-blind treatment period.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Count of Participants

Participants

Week 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Secondary

Complete Response With Glucocorticoid Taper to ≤10 mg

Percentage of participants who achieved complete response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Number

95% Confidence Interval

percent of participants

Weeks 12, 16, 20, and 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units

Secondary

Complete Response With Glucocorticoid Taper to ≤5 mg

Percentage of participants who achieved complete response and glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Number

95% Confidence Interval

percent of participants

Weeks 12, 16, 20, and 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units	Counts

Secondary

Complete Response With Glucocorticoid Taper to 0 mg

Percentage of participants who achieved complete response with glucocorticoid taper to 0 mg by Week 24 of the double-blind treatment period.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Number

95% Confidence Interval

percent of participants

Weeks 12, 16, 20, and 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units	Counts

Secondary

Partial Response With Glucocorticoid Taper to ≤10 mg

Percentage of participants who achieved partial response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Number

95% Confidence Interval

percent of participants

Week 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units	Counts

Secondary

Partial Response With Glucocorticoid Taper to ≤5 mg

Percentage of participants who achieved partial response and glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Number

95% Confidence Interval

percent of participants

Week 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units	Counts

Secondary

Partial Response With Glucocorticoid Taper to 0 mg

Percentage of participants who achieved partial response with glucocorticoid taper to 0 mg by Week 24 of the double-blind treatment period.

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Number

95% Confidence Interval

percent of participants

Week 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units	Counts

Other Pre-specified

Change From Baseline in Glucocorticoid Dose

Mean change from Baseline in glucocorticoid dose for participants during the double-blind treatment period at Weeks 12, 16, 20 and 24

The Intent to Treat (ITT) Set included all randomized participants (N=24).

Posted

Mean

Standard Deviation

mg/day

Weeks 12, 16, 20, and 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Units	Counts

Post-Hoc

Complete Response With Glucocorticoid Taper to ≤10 mg (Subset of Participants on Steroids at Screening)

For the subset of the intent to treat population who were on glucocorticoid steroids at Screening, the percentage of participants who achieved complete response with successful glucocorticoid taper to ≤10 mg by Week 24 of the double-blind treatment period is presented.

The subset of participants in the intent to treat population who were on glucocorticoids at Screening.

Posted

Number

95% Confidence Interval

percent of participants

Weeks 12, 16, 20, and 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Post-Hoc

Complete Response With Glucocorticoid Taper to ≤5 mg (Subset of Participants on Steroids at Screening)

For the subset of the intent to treat population who were on glucocorticoid steroids at Screening, the percentage of participants who achieved complete response with successful glucocorticoid taper to ≤5 mg by Week 24 of the double-blind treatment period is presented.

The subset of participants in the intent to treat population who were on glucocorticoids at Screening. Of note, one participant met the SAP definition of CR with glucocorticoid taper to 0 mg at Week 4 with normalized ALT, AST, and IgG while taking no glucocorticoid steroids and is included in this dataset. After further review of the data, notes in the database stated the reason for the participant taking no glucocorticoids for 7 days was due to the glucocorticoid medication unavailability.

Posted

Number

95% Confidence Interval

percent of participants

Weeks 12, 16, 20, and 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)

Post-Hoc

Complete Response With Glucocorticoid Taper to 0 mg (Subset of Participants on Steroids at Screening)

For the subset of the intent to treat population who were on glucocorticoid steroids at Screening, the percentage of participants who achieved complete response with successful glucocorticoid taper to 0 mg by Week 24 of the double-blind treatment period is presented.

Posted

Number

95% Confidence Interval

percent of participants

Weeks 12, 16, 20, and 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)

Post-Hoc

Complete Response (Subset of Participants on Steroids at Screening)

For the subset of the intent to treat population who were on glucocorticoid steroids at Screening, the percentage of participants who achieved complete response by Week 24 of the double-blind treatment period is presented.

The subset of participants in the intent to treat population who were on glucocorticoids at Screening.

Posted

Number

95% Confidence Interval

percent of participants

Weeks 12, 16, 20, and 24

ID	Title	Description
OG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
OG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the treatment period in addition to standard of care during the double-blind treatment period. placebo: Subcutaneous injection of placebo

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Increased tendency to bruise	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG0030 events0 affected5 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Palpitations	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 27.0	Systematic Assessment	EG00014 events1 affected16 at risk EG0010 events0 affected7 at risk EG0025 events2 affected9 at risk EG003
Ear discomfort	Ear and labyrinth disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Conjunctival haemorrhage	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Diplopia	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Vision blurred	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Visual impairment	Eye disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected7 at risk EG0022 events1 affected9 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0005 events2 affected16 at risk EG0012 events2 affected7 at risk EG0020 events0 affected9 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0005 events4 affected16 at risk EG0012 events2 affected7 at risk EG0021 events1 affected9 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected16 at risk EG0011 events1 affected7 at risk EG0021 events1 affected9 at risk EG003
Dyschezia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Frequent bowel movements	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG00023 events6 affected16 at risk EG0017 events2 affected7 at risk EG00210 events4 affected9 at risk EG003
Oesophageal pain	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Paraesthesia oral	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Varices oesophageal	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 27.0	Systematic Assessment	EG0007 events4 affected16 at risk EG0011 events1 affected7 at risk EG0023 events2 affected9 at risk EG003
Application site purpura	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Asthenia	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0005 events2 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Chest discomfort	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Chills	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG00034 events9 affected16 at risk EG00112 events2 affected7 at risk EG00222 events6 affected9 at risk EG003
Cyst	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Fatigue	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG00028 events6 affected16 at risk EG0013 events3 affected7 at risk EG0026 events4 affected9 at risk EG003
Influenza like illness	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Injection site bruising	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG00019 events7 affected16 at risk EG0018 events4 affected7 at risk EG0022 events2 affected9 at risk EG003
Injection site discolouration	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Injection site discomfort	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0004 events2 affected16 at risk EG0016 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Injection site erythema	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG00076 events12 affected16 at risk EG0013 events2 affected7 at risk EG00214 events3 affected9 at risk EG003
Injection site exfoliation	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Injection site haematoma	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Injection site hypoaesthesia	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Injection site induration	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG00040 events5 affected16 at risk EG0010 events0 affected7 at risk EG0022 events1 affected9 at risk EG003
Injection site inflammation	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Injection site mass	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Injection site nodule	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected16 at risk EG0010 events0 affected7 at risk EG0023 events2 affected9 at risk EG003
Injection site pain	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG00050 events10 affected16 at risk EG0012 events1 affected7 at risk EG0028 events3 affected9 at risk EG003
Injection site papule	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Injection site paraesthesia	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Injection site pruritus	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG00054 events7 affected16 at risk EG0010 events0 affected7 at risk EG00211 events3 affected9 at risk EG003
Injection site rash	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0009 events5 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Injection site swelling	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG00010 events5 affected16 at risk EG0010 events0 affected7 at risk EG0024 events2 affected9 at risk EG003
Injection site urticaria	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Injection site vesicles	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected7 at risk EG0022 events1 affected9 at risk EG003
Injection site warmth	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Malaise	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Non-cardiac chest pain	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Oedema peripheral	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Pain	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG00013 events6 affected16 at risk EG0013 events3 affected7 at risk EG0025 events5 affected9 at risk EG003
Peripheral swelling	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Pyrexia	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG00023 events8 affected16 at risk EG0012 events2 affected7 at risk EG0025 events4 affected9 at risk EG003
Swelling face	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Tenderness	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Thirst	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Vaccination site bruising	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Vessel puncture site bruise	General disorders and administration site conditions	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Ocular icterus	Hepatobiliary disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Bronchitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
COVID-19	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Fungal infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Herpes zoster	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Hordeolum	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0003 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Influenza	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Otitis media acute	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Sinusitis	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Tooth abscess	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected7 at risk EG0021 events1 affected9 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0014 events2 affected7 at risk EG0020 events0 affected9 at risk EG003
Craniofacial fracture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Post procedural erythema	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Post procedural pruritus	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Blood glucose increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Blood pressure increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Body temperature increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Crystal urine present	Investigations	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Heart rate decreased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Heart rate increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected16 at risk EG0012 events2 affected7 at risk EG0020 events0 affected9 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0003 events3 affected16 at risk EG0014 events4 affected7 at risk EG0021 events1 affected9 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0012 events2 affected7 at risk EG0020 events0 affected9 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0006 events4 affected16 at risk EG0016 events3 affected7 at risk EG0021 events1 affected9 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Cranial nerve neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Haemangioma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Anosmia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Balance disorder	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Brain fog	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Dizziness	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Headache	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG00042 events9 affected16 at risk EG0019 events4 affected7 at risk EG00210 events4 affected9 at risk EG003
Lethargy	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0022 events2 affected9 at risk EG003
Memory impairment	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Migraine	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0021 events1 affected9 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0022 events2 affected9 at risk EG003
Tremor	Nervous system disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Depressed mood	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Listless	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0003 events2 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Poor quality sleep	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Micturition urgency	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0004 events3 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Hair growth abnormal	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0002 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0002 events2 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Pityriasis rosea	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0007 events2 affected16 at risk EG0010 events0 affected7 at risk EG0029 events4 affected9 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0005 events3 affected16 at risk EG0012 events2 affected7 at risk EG0021 events1 affected9 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Rosacea	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0011 events1 affected7 at risk EG0020 events0 affected9 at risk EG003
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 27.0	Systematic Assessment	EG0007 events2 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Flushing	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0021 events1 affected9 at risk EG003
Haematoma	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Hot flush	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003
Hypertension	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0000 events0 affected16 at risk EG0010 events0 affected7 at risk EG0028 events1 affected9 at risk EG003
Peripheral vascular haematoma	Vascular disorders	MedDRA 27.0	Systematic Assessment	EG0001 events1 affected16 at risk EG0010 events0 affected7 at risk EG0020 events0 affected9 at risk EG003

ID	Title	Description
BG000	Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the double-blind treatment period in addition to standard of care. Participants who completed the double-blind treatment period could elect to continue in the open-label extension (OLE) period of the study. Participants who enrolled in the OLE period received an initial 30 mg dose of zetomipzomib at the OLE Week 1 visit, followed by weekly doses of 60 mg of zetomipzomib in addition to standard of care, for up to a total of 24 additional weeks of treatment. zetomipzomib: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly
BG001	Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the double-blind treatment period in addition to standard of care. placebo: Subcutaneous injection of placebo Participants who completed the double-blind treatment period could elect to continue in the open-label extension (OLE) period of the study. Participants who enrolled in the OLE period received an initial 30 mg dose of zetomipzomib at the OLE Week 1 visit, followed by weekly doses of 60 mg of zetomipzomib in addition to standard of care, for up to a total of 24 additional weeks of treatment.
BG002	Total	Total of all reporting groups

ID	Term
D006521	Hepatitis, Chronic
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Double-blind Treatment Period: Zetomipzomib + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of zetomipzomib, followed by weekly 60 mg doses of zetomipzomib, for the remaining 23 weeks of the double-blind treatment period in addition to standard of care. zetomipzomib in the double-blind treatment period: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly	16	2	16	16	16
EG001	Double-blind Treatment Period: Placebo + Standard-of-care (Glucocorticoids)	Participants received an initial 30 mg dose of placebo (sterile water for injection), followed by weekly 60 mg doses of placebo, for the remaining 23 weeks of the double-blind treatment period in addition to standard of care. placebo in the double-blind treatment period: Subcutaneous injection of placebo	7	1	7	7	7
EG002	Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Zetomipzomib in DBTP)	Participants, who received zetomipzomib in the double-blind treatment period (DBTP) and enrolled in the open-label extension period, received an initial 30 mg dose of zetomipzomib at the open-label extension (OLE) Week 1 visit, followed by weekly doses of 60 mg of zetomipzomib, for up to a total of 24 additional weeks of treatment in addition to standard of care. zetomipzomib in OLE who received zetomipzomib during the DBTP: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly	9	0	9	9	9
EG003	Open-label Extension: Zetomipzomib + standard-of Care (Glucocorticoids) (Placebo in DBTP)	Participants, who received placebo in the double-blind treatment period (DBTP) and enrolled in the open-label extension period, received an initial 30 mg dose of zetomipzomib at the open-label extension (OLE) Week 1 visit, followed by weekly doses of 60 mg of zetomipzomib, for up to a total of 24 additional weeks of treatment in addition to standard of care. zetomipzomib in OLE who received placebo during the DBTP: Subcutaneous injection of zetomipzomib with a target dose of 60 mg weekly	5	0	5	5	5