Study of Daxdilimab (HZN-7734) in Participants With Activ... | NCT05540665

NCT05540665

ID	Type	Description	Link
2022-001377-31	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Daxdilimab Arm 1	Experimental	Daxdilimab injections over a total of 104 weeks	Drug: Daxdilimab
Daxdilimab Arm 2	Experimental	Daxdilimab injections over a total of 104 weeks	Drug: Daxdilimab
Placebo	Placebo Comparator	Placebo injections over a total of 104 weeks	Drug: Placebo (Normal Saline)

Name	Type	Description	Arm Group Labels	Other Names
Daxdilimab	Drug	Daxdilimab will be administered subcutaneously as two injections for each dose. Other Names: HZN-7734	Daxdilimab Arm 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved CRR at Week 48 Through Week 52	CRR was defined as meeting all of the following: Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline 24-hour urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment	Week 48 to Week 52

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Who Achieved Overall Renal Response (ORR) at Week 48 Through Week 52	CRR was defined as meeting all of the following: EGFR ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline 24-hour UPCR ≤ 0.5 mg/mg No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment Partial renal response (PRR) was defined as meeting all of the following: EGFR ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline Improvement in 24-hour UPCR: For participants with a Baseline UPCR ≤ 3.0 mg/mg: < 1.0 mg/mg For participants with a Baseline UPCR > 3.0 mg/mg: > 50% improvement from baseline and ≤ 3.0 mg/mg No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Willing and able to understand and provide written informed consent
Adult men or women 18 to 80 years of age
Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial
Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus (SLE)
Have at least one of the following at Screening per central lab:
- Antinuclear antibodies (ANA) ≥ 1:80
- Anti-dsDNA antibodies elevated to above normal range as established by the central laboratory (ie, positive results)
- Anti-Smith antibodies elevated to above normal (ie, positive results).
Diagnosis of proliferative LN based on a renal biopsy obtained within 6 months prior to signing the informed consent form (ICF) or during the Screening Period:
- Class III (± class V) or class IV (± class V) LN according to the World Health Organization (WHO) or 2003 International Society of Nephrology (ISN)/Renal Pathology Society (RPS) classification (based on local evaluation of renal biopsy).
Urine protein to creatinine ratio ≥113.17 mg/mmol, obtained via a 24-hour urine collection at Screening.
Estimated glomerular filtration rate ≥35 mL/min/1.73 m2
Negative serum beta-human chorionic gonadotropin test at Screening (females of childbearing potential only).

Key Exclusion Criteria:

History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the investigational product or to a previous monoclonal antibody or human immunoglobulin therapy.
Known intolerance to ≤1.0 gm/day of MMF or equivalent dose of mycophenolic acid (MPA).
A diagnosis of pure Class V membranous LN based on a renal biopsy obtained within 6 months prior to signing ICF or during the Screening Period.
History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a 12-month period after enrollment.
History of, or current renal diseases (other than LN) that in the opinion of the Investigator could interfere with the LN assessment and confound the disease activity assessment (eg, diabetic nephropathy).
Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, a positive result for HIV infection per central laboratory, splenectomy, or any underlying condition that in the opinion of the Investigator significantly predisposes the participant to infection.
Hepatitis B, Hepatitis C, active tuberculosis (TB), any severe herpes infection, clinically active infection, or opportunistic infection.
Clinically significant cardiac disease including unstable angina, myocardial infarction, congestive heart failure within 6 months prior to Randomization.
History of cancer within the past 5 years, except in situ carcinoma of the cervix, cutaneous basal cell or squamous cell carcinoma with curative therapy.
Receipt of a live vaccine within 4 weeks prior to Day 1.
The use of immunosuppressants, biologics, and DMARDS within the protocol defined washout periods.

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233-2110	United States
California Kidney Specialists

References Module

Label	URL
AmgenTrials clinical trials website	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 17, 2022	Dec 12, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Full Analysis Set: all randomized participants who received any dose of IP.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
BG001	Daxdilimab 100 mg	Participants were randomized to receive daxdilimab 100 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
BG002	Daxdilimab 300 mg	Participants were randomized to receive daxdilimab 300 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.2± 5.91 BG00131.5± 10.97 BG00230.3± 6.47 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006 BG0016 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Asian

Title	Measurements
	BG0001 BG0014 BG002

Race/Ethnicity, Customized

Number

Participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG0003 BG0010 BG002

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

Percentage of Participants Who Achieved CRR at Week 48 Through Week 52

CRR was defined as meeting all of the following:

Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline
24-hour urine protein to creatinine ratio (UPCR) ≤ 0.5 mg/mg
No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment

Due to early termination data were not collected.

Posted

Week 48 to Week 52

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
OG001	Daxdilimab 100 mg	Participants were randomized to receive daxdilimab 100 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
OG002	Daxdilimab 300 mg	Participants were randomized to receive daxdilimab 300 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

Units	Counts
Participants	OG0000 OG0010 OG0020

Secondary

Percentage of Participants Who Achieved Overall Renal Response (ORR) at Week 48 Through Week 52

CRR was defined as meeting all of the following:

EGFR ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline
24-hour UPCR ≤ 0.5 mg/mg
No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment

Partial renal response (PRR) was defined as meeting all of the following:

EGFR ≥ 60 mL/min/1.73 m^2 or no worse than 15% below Baseline
Improvement in 24-hour UPCR:
- For participants with a Baseline UPCR ≤ 3.0 mg/mg: < 1.0 mg/mg
- For participants with a Baseline UPCR > 3.0 mg/mg: > 50% improvement from baseline and ≤ 3.0 mg/mg
No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment

Due to early termination data were not collected.

Posted

Week 48 to Week 52

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

Secondary

Change From Baseline in eGFR at Week 52

Change over time in the levels of eGRF present in the blood.

Due to early termination data were not collected.

Posted

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
OG001	Daxdilimab 100 mg	Participants were randomized to receive daxdilimab 100 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

Secondary

Proportion of Participants Achieving a Decrease in Daily Oral Corticosteroid (OCS) Dose of ≤ 2.5 mg Prednisone-Equivalent by Week 24 Maintained Through Week 52

Sustained reduction of OCS dose:

Prednisone-equivalent dose ≤ 2.5 mg/day by Week 24 and not exceeding this dose through Week 52 and
No discontinuation of trial intervention or use of restricted medication beyond the protocol-allowed threshold before assessment

Due to early termination data were not collected.

Posted

Week 24 to Week 52

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
OG001	Daxdilimab 100 mg	Participants were randomized to receive daxdilimab 100 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

Secondary

Serum Concentration of Daxdilimab

Levels of daxdilimab present in the blood serum at different time points.

Pharmacokinetic (PK) Analysis Set: all participants who received any dose of daxdilimab and had at least 1 quantifiable PK observation following the initial dose.

Posted

Mean

Standard Deviation

ng/mL

Week 0 pre-dose, and 6 hours post-dose; Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, and Week 36

ID	Title	Description
OG000	Daxdilimab 100 mg	Participants were randomized to receive daxdilimab 100 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
OG001	Daxdilimab 300 mg	Participants were randomized to receive daxdilimab 300 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

Secondary

Number of Participants With Detectable Anti-Drug Antibodies (ADA) Against Daxdilimab

Assessed via blood test at multiple time points throughout the duration of the study.

Safety Analysis Set: All participants who received any dose of IP in the trial.

Posted

Count of Participants

Participants

Up to approximately 36 weeks

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.
OG001	Daxdilimab 100 mg	Participants were randomized to receive daxdilimab 100 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

Secondary

Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

An AE was any untoward medical occurrence in a participant or clinical subject who was administered a pharmaceutical product, which may or may not have been causally related to the treatment. A serious AE (SAE) was any AE resulting in death, life-threatening situations, inpatient hospitalization or its prolongation, persistent/significant disability/incapacity, congenital abnormality/birth defect, or other significant medical events that may have jeopardized the participant or required medical/surgical intervention to prevent the outcomes listed above. Treatment-emergent AEs of special interest (AESI) included hypersensitivity reactions (e.g., anaphylaxis), severe viral infections/reactivations (Common Terminology for Adverse Events [CTCAE] Grade 3+), herpes zoster, opportunistic infections, and malignancies.

Safety Analysis Set: All participants who received any dose of IP in the trial.

Posted

Count of Participants

Participants

Up to approximately 36 weeks

ID	Title	Description
OG000	Placebo	Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants were randomized to receive placebo SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. Thereafter, placebo was administered every 4 weeks (Q4W) through Week 52. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved either partial renal response (PRR) or complete renal response (CRR) at both Weeks 48 and 52 would have continued to receive placebo at Week 64 and every 12 weeks (Q12W) through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at either Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and then Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.	6	0	6	2	6
EG001	Daxdilimab 100 mg	Participants were randomized to receive daxdilimab 100 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 100 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.	6	0	6	2	6
EG002	Daxdilimab 300 mg	Participants were randomized to receive daxdilimab 300 mg SC in addition to SOC background therapy at Day 1, Week 2, and Week 4. From Week 8 through Week 52, daxdilimab was administered Q4W. At Week 64, dosing would have been adjusted based on renal response criteria: participants who achieved PRR or CRR at both Weeks 48 and 52 would have continued to receive daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. Participants who didn't achieve PRR or CRR at Week 48 or 52 would have received daxdilimab 300 mg at Week 64 and Q12W through Week 104 (last dose at Week 100), in addition to SOC therapy. However, the study was terminated prior to any participants reaching Week 64.	7	1	7	5	7
EG003	Daxdilimab Total	All participants who were exposed to daxdilimab.	13	1	13	7	13
EG004	Total	Total	19	1	19	9	19

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Gastrointestinal infection	Infections and infestations	MedDRA 25.0	Systematic Assessment		EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG0031 affected13 at risk EG0041 affected19 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cushingoid	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG0031 affected13 at risk EG0041 affected19 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Influenza	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Urinary sediment abnormal	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected7 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Butterfly rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected7 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003
Hypertension	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected7 at risk EG003

The study was terminated early following a sponsor decision.

Certain Agreements

First MCP Posted Date

ID	Term
D008181	Lupus Nephritis

Ancestor Terms

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
D008180	Lupus Erythematosus, Systemic
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D000077330	Saline Solution

EG0041 affected19 at risk

Standard deviation (SD) not calculated due to the low level of observations.

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations