Trial Outcomes & Findings for Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study (NCT NCT05430854)
NCT ID: NCT05430854
Last Updated: 2024-09-19
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose date in the OLE study.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
155 participants
Primary outcome timeframe
Up to approximately 56 weeks
Results posted on
2024-09-19
Participant Flow
This was an open-label extension (OLE) of study VIB7734.P2.S1 (NCT04925934). Eligible participants were enrolled after the completion of the VIB7734.P2.S1 study. 155 participants were enrolled at 54 centers in the United States, Argentina, Greece, India, Mexico, Poland, Serbia, Spain and Taiwan from 01 June 2022 to 31 October 2023.
Participant milestones
| Measure |
Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W)
Participants who received placebo in the parent study received daxdilimab 200 mg subcutaneous (SC) injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
47
|
57
|
51
|
|
Overall Study
COMPLETED
|
8
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
39
|
53
|
46
|
Reasons for withdrawal
| Measure |
Placebo/Daxdilimab 200 mg Every 12 Weeks (Q12W)
Participants who received placebo in the parent study received daxdilimab 200 mg subcutaneous (SC) injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Every 4 Weeks (Q4W)/Daxdilimab 200 mg Q12W
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
|---|---|---|---|
|
Overall Study
Trial terminated by Sponsor
|
39
|
50
|
46
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
Baseline Characteristics
Study of Daxdilimab (HZN-7734) for the Treatment of Systemic Lupus Erythematosus in an Open-label Extension Study
Baseline characteristics by cohort
| Measure |
Placebo/Daxdilimab 200 mg Q12W
n=47 Participants
Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q4W in Parent Study
n=57 Participants
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
n=51 Participants
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.3 Years
STANDARD_DEVIATION 10.3 • n=99 Participants
|
44.8 Years
STANDARD_DEVIATION 12.8 • n=107 Participants
|
45.9 Years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
44.1 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
142 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
59 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
109 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 56 weeksPopulation: OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an IP, whether or not considered related to the IP. A TEAE is defined as any AE with an onset date on or after the first dose date in the OLE study.
Outcome measures
| Measure |
Placebo/Daxdilimab 200 mg Q12W
n=47 Participants
Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q4W in Parent Study
n=57 Participants
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
n=51 Participants
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
|---|---|---|---|
|
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
|
25 Participants
|
31 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 56 weeksPopulation: OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
An AE is considered "serious" if, in the view of either the Investigator or Sponsor, it results in any of the following outcomes: * Death * A life-threatening AE * Inpatient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions * A congenital abnormality/birth defect * Important medical events judged to jeopardize the participant(s).
Outcome measures
| Measure |
Placebo/Daxdilimab 200 mg Q12W
n=47 Participants
Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q4W in Parent Study
n=57 Participants
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
n=51 Participants
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
|---|---|---|---|
|
Number of Participants Who Experienced Serious Adverse Events (SAEs)
|
3 Participants
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 56 weeksPopulation: OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study.
An AESI is an AE of scientific and medical interest specific to understanding of the IP and may require close monitoring and collection of additional information by the Investigator. In this study, AESIs were: * Hypersensitivity reaction, including anaphylaxis * Severe (Grade 3 or higher) viral infections/reactivations * Opportunistic infections * Malignancy (except non-melanoma skin cancer).
Outcome measures
| Measure |
Placebo/Daxdilimab 200 mg Q12W
n=47 Participants
Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q4W in Parent Study
n=57 Participants
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
n=51 Participants
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
|---|---|---|---|
|
Number of Participants Who Experienced AEs of Special Interest (AESI)
|
1 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56Population: PK Analysis Set: all participants who received any dose of daxdilimab in OLE study and had at least 1 measurable PK concentration post dose. Number analyzed represents the number of participants with available data at that time point.
Serum concentration of daxdilimab refers to the amount of daxdilimab present in the blood serum at a given time. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study.
Outcome measures
| Measure |
Placebo/Daxdilimab 200 mg Q12W
n=47 Participants
Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q4W in Parent Study
n=57 Participants
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
n=51 Participants
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
|---|---|---|---|
|
Serum Concentration of Daxdilimab
Week 0
|
—
|
5.527 ug/mL
Standard Deviation 4.412
|
0.458 ug/mL
Standard Deviation 0.614
|
|
Serum Concentration of Daxdilimab
Week 12
|
0.291 ug/mL
Standard Deviation 0.390
|
0.502 ug/mL
Standard Deviation 0.740
|
0.400 ug/mL
Standard Deviation 0.520
|
|
Serum Concentration of Daxdilimab
Week 24
|
0.414 ug/mL
Standard Deviation 0.575
|
0.398 ug/mL
Standard Deviation 0.531
|
0.437 ug/mL
Standard Deviation 0.437
|
|
Serum Concentration of Daxdilimab
Week 36
|
0.508 ug/mL
Standard Deviation 0.616
|
0.464 ug/mL
Standard Deviation 0.467
|
1.002 ug/mL
Standard Deviation 1.404
|
|
Serum Concentration of Daxdilimab
Week 48
|
0.813 ug/mL
Standard Deviation 1.044
|
0.380 ug/mL
Standard Deviation 0.395
|
0.815 ug/mL
Standard Deviation 0.759
|
|
Serum Concentration of Daxdilimab
Week 56
|
0.399 ug/mL
Standard Deviation 0.251
|
0.146 ug/mL
Standard Deviation 0.009
|
0.997 ug/mL
Standard Deviation 0.898
|
SECONDARY outcome
Timeframe: Week 0 (Week 0 = Day 1), Week 12, Week 24, Week 36, Week 48, Week 56Population: OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. The overall number of participants analzyed represents the number of participants contributing data to any individual timepoint within the table.
PDCs count refers to the number of pDCs present in a blood sample. Blood samples were collected via venipuncture at the specified time frames. Week 0 corresponds to the last day of the treatment period in the parent study and Day 1 of the treatment period in the OLE study.
Outcome measures
| Measure |
Placebo/Daxdilimab 200 mg Q12W
n=47 Participants
Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q4W in Parent Study
n=57 Participants
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
n=51 Participants
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
|---|---|---|---|
|
Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
Week 24
|
-14.39 Percentage change in pDCs count
Standard Deviation 164.63
|
-24.98 Percentage change in pDCs count
Standard Deviation 79.85
|
-19.86 Percentage change in pDCs count
Standard Deviation 77.23
|
|
Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
Week 0
|
70.59 Percentage change in pDCs count
Standard Deviation 225.39
|
-58.37 Percentage change in pDCs count
Standard Deviation 36.19
|
-30.40 Percentage change in pDCs count
Standard Deviation 50.67
|
|
Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
Week 12
|
1.33 Percentage change in pDCs count
Standard Deviation 142.08
|
13.57 Percentage change in pDCs count
Standard Deviation 158.14
|
-21.25 Percentage change in pDCs count
Standard Deviation 66.97
|
|
Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
Week 36
|
13.64 Percentage change in pDCs count
Standard Deviation 255.67
|
-41.36 Percentage change in pDCs count
Standard Deviation 41.29
|
-51.11 Percentage change in pDCs count
Standard Deviation 35.28
|
|
Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
Week 48
|
-49.47 Percentage change in pDCs count
Standard Deviation 34.54
|
-58.65 Percentage change in pDCs count
Standard Deviation 43.33
|
-4.44 Percentage change in pDCs count
Standard Deviation 74.93
|
|
Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Count
Week 56
|
-75.22 Percentage change in pDCs count
Standard Deviation 14.11
|
-43.13 Percentage change in pDCs count
Standard Deviation 49.49
|
4.15 Percentage change in pDCs count
Standard Deviation 96.43
|
SECONDARY outcome
Timeframe: Up to approximately 56 weeksPopulation: Any Daxdilimab Analysis Set: all participants who received at least 1 dose of daxdilimab in parent study or OLE study.
ADA incidence is the number of the participants with ADA positive post-Baseline only or boosted their preexisting ADA during the trial. Persistent positive was defined as ADA positive at ≥ 2 post-Baseline assessments (with ≥ 16 weeks between first and last positive) or positive at last post-Baseline assessment. Transient positive was defined as ADA post-Baseline positive but did not fulfill the criteria of persistent positive.
Outcome measures
| Measure |
Placebo/Daxdilimab 200 mg Q12W
n=47 Participants
Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q4W in Parent Study
n=57 Participants
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
n=51 Participants
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
|---|---|---|---|
|
Number of Participants Expressing Anti-drug Antibodies (ADA)
ADA not detected
|
34 Participants
|
48 Participants
|
44 Participants
|
|
Number of Participants Expressing Anti-drug Antibodies (ADA)
ADA Incidence
|
7 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Expressing Anti-drug Antibodies (ADA)
Only Baseline positive
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants Expressing Anti-drug Antibodies (ADA)
Only post-Baseline positive
|
6 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants Expressing Anti-drug Antibodies (ADA)
Both Baseline and post-Baseline positive
|
7 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Expressing Anti-drug Antibodies (ADA)
Persistent positive
|
4 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Expressing Anti-drug Antibodies (ADA)
Transient positive
|
9 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Placebo/Daxdilimab 200 mg Q12W
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Daxdilimab 200 mg Q4W in Parent Study
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
Serious events: 5 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo/Daxdilimab 200 mg Q12W
n=47 participants at risk
Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q4W in Parent Study
n=57 participants at risk
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
n=51 participants at risk
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
2.0%
1/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
1.8%
1/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
2.0%
1/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
2.0%
1/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
2.0%
1/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Cardiac disorders
Myocardial ischaemia
|
2.1%
1/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
1.8%
1/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
2.0%
1/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Infections and infestations
Cytomegalovirus nephritis
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
1.8%
1/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
1.8%
1/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
1.8%
1/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Infections and infestations
Meningitis
|
2.1%
1/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
1.8%
1/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
2.1%
1/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Renal and urinary disorders
Glomerulonephritis minimal lesion
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
1.8%
1/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
Other adverse events
| Measure |
Placebo/Daxdilimab 200 mg Q12W
n=47 participants at risk
Participants who received placebo in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q4W in Parent Study
n=57 participants at risk
Participants who received 200 mg Q4W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
Daxdilimab 200 mg Q12W/Daxdilimab 200 mg Q12W
n=51 participants at risk
Participants who received 200 mg Q12W in the parent study received daxdilimab 200 mg SC injection Q12W in this OLE Study.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
5.9%
3/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Infections and infestations
COVID-19
|
8.5%
4/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
3.9%
2/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
1/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
5.3%
3/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
2.0%
1/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Infections and infestations
Sinusitis
|
2.1%
1/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
3.5%
2/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
5.9%
3/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
1/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
9.8%
5/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
3.5%
2/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
5.9%
3/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
4.3%
2/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
7.0%
4/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
2.0%
1/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Nervous system disorders
Headache
|
6.4%
3/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
5.3%
3/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
2.0%
1/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
3.5%
2/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
5.9%
3/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
5.3%
3/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
0.00%
0/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
1.8%
1/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
7.8%
4/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
|
Vascular disorders
Hypertension
|
8.5%
4/47 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
1.8%
1/57 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
3.9%
2/51 • Up to approximately 56 weeks
Serious and other AEs is reported for the OLE Safety Analysis Set: all participants who received at least 1 dose of daxdilimab in the OLE study. All-cause mortality is reported for all participants enrolled/randomized in the study.
|
Additional Information
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