Trial Outcomes & Findings for Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN) (NCT NCT05540665)

Last Updated: 2025-03-24

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Week 48 to Week 52

Results posted on

2025-03-24

Participant Flow

Participants with active proliferative lupus nephritis were recruited from centers in Argentina, Brazil, Malaysia, the Philippines, Poland, Serbia, and Thailand between April 2023 and January 2024, when the study was terminated.

Participants were randomized in a 1:1:1 ratio to receive either daxdilimab 300 mg or 100 mg subcutaneously (SC) or placebo SC in addition to standard of care (SOC) background therapy for a Treatment Period of about 104 weeks. Participants were followed up for 12 weeks following last dose of investigational product (IP).

Participant milestones

Participant milestones
Measure	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.	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.	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.
Overall Study STARTED	6	6	7
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	6	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.	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.
Overall Study Study terminated by sponsor	6	6	7

Baseline Characteristics

Study of Daxdilimab (HZN-7734) in Participants With Active Proliferative Lupus Nephritis (LN)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=6 Participants 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.	Daxdilimab 100 mg n=6 Participants 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.	Daxdilimab 300 mg n=7 Participants 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.	Total n=19 Participants Total of all reporting groups
Age, Continuous	37.2 years STANDARD_DEVIATION 5.91 • n=5 Participants	31.5 years STANDARD_DEVIATION 10.97 • n=7 Participants	30.3 years STANDARD_DEVIATION 6.47 • n=5 Participants	32.8 years STANDARD_DEVIATION 8.15 • n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 48 to Week 52

Population: Due to early termination data were not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 48 to Week 52

Population: Due to early termination data were not collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 52

Population: Due to early termination data were not collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 24 to Week 52

Population: Due to early termination data were not collected.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

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

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

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants 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.	Daxdilimab 100 mg n=7 Participants 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.	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.
Serum Concentration of Daxdilimab Week 12	2988.00 ng/mL Standard Deviation 1223.83	10201.67 ng/mL Standard Deviation 4619.64	—
Serum Concentration of Daxdilimab Week 24	93.85 ng/mL Standard Deviation 94.96	9660.00 ng/mL Standard Deviation NA Standard deviation (SD) not calculated due to the low level of observations.	—
Serum Concentration of Daxdilimab Week 0 pre-dose	7.80 ng/mL Standard Deviation 0.00	7.80 ng/mL Standard Deviation 0.00	—
Serum Concentration of Daxdilimab Week 0 post-dose	689.07 ng/mL Standard Deviation 498.40	3854.29 ng/mL Standard Deviation 3312.12	—
Serum Concentration of Daxdilimab Week 2	4996.67 ng/mL Standard Deviation 1732.21	17610.00 ng/mL Standard Deviation 10382.53	—
Serum Concentration of Daxdilimab Week 4	8531.67 ng/mL Standard Deviation 3993.99	22171.43 ng/mL Standard Deviation 9187.26	—
Serum Concentration of Daxdilimab Week 8	3533.33 ng/mL Standard Deviation 1727.54	10330.00 ng/mL Standard Deviation 4167.07	—
Serum Concentration of Daxdilimab Week 16	1080.33 ng/mL Standard Deviation 1020.32	5051.50 ng/mL Standard Deviation 6644.68	—
Serum Concentration of Daxdilimab Week 20	240.83 ng/mL Standard Deviation 184.66	2003.00 ng/mL Standard Deviation 3907.13	—
Serum Concentration of Daxdilimab Week 36	—	1040.00 ng/mL Standard Deviation NA SD not calculated due to the low level of observations.	—

SECONDARY outcome

Timeframe: Up to approximately 36 weeks

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

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

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants 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.	Daxdilimab 100 mg n=6 Participants 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.	Daxdilimab 300 mg n=7 Participants 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.
Number of Participants With Detectable Anti-Drug Antibodies (ADA) Against Daxdilimab	6 Participants	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to approximately 36 weeks

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

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.

Outcome measures

Outcome measures
Measure	Placebo n=6 Participants 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.	Daxdilimab 100 mg n=6 Participants 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.	Daxdilimab 300 mg n=7 Participants 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.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All TEAEs	2 Participants	2 Participants	5 Participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All SAEs	0 Participants	0 Participants	1 Participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) All ≥ Grade 3 AESI	0 Participants	0 Participants	0 Participants
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) Fatal AEs	0 Participants	0 Participants	0 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Daxdilimab 100 mg

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Daxdilimab 300 mg

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Daxdilimab Total

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Total

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=6 participants at risk 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.	Daxdilimab 100 mg n=6 participants at risk 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.	Daxdilimab 300 mg n=7 participants at risk 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.	Daxdilimab Total n=13 participants at risk All participants who were exposed to daxdilimab.	Total n=19 participants at risk Total
Infections and infestations Gastrointestinal infection	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	14.3% 1/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.

Other adverse events

Other adverse events
Measure	Placebo n=6 participants at risk 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.	Daxdilimab 100 mg n=6 participants at risk 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.	Daxdilimab 300 mg n=7 participants at risk 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.	Daxdilimab Total n=13 participants at risk All participants who were exposed to daxdilimab.	Total n=19 participants at risk Total
Endocrine disorders Cushingoid	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	16.7% 1/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	14.3% 1/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	14.3% 1/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Infections and infestations Influenza	16.7% 1/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	16.7% 1/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Investigations Urinary sediment abnormal	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	14.3% 1/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Metabolism and nutrition disorders Hypokalaemia	16.7% 1/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	16.7% 1/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	16.7% 1/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	16.7% 1/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Skin and subcutaneous tissue disorders Butterfly rash	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	16.7% 1/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	14.3% 1/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	14.3% 1/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.
Vascular disorders Hypertension	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	0.00% 0/6 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	14.3% 1/7 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	7.7% 1/13 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.	5.3% 1/19 • Up to approximately 36 weeks All-cause mortality is reported for all participants randomized in the study. Serious adverse events and other adverse events are reported for all participants who received at least one dose of trial drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER