Study of VIB7734 for the Treatment of Moderate to Severel... | NCT04925934

NCT04925934

ID	Type	Description	Link
2020-005528-12	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	Intervention Names
VIB7734 SC (dosing interval 1)	Experimental	Drug: VIB7734
VIB7734 SC (dosing interval 2)	Experimental	Drug: VIB7734
Placebo SC (dosing interval 3)	Placebo Comparator	Other: Placebo

Name	Type	Description	Arm Group Labels	Other Names
VIB7734	Drug	VIB7734	VIB7734 SC (dosing interval 1) VIB7734 SC (dosing interval 2)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Achieving a BILAG-2004 Index-based Combined Lupus Assessment (BICLA) Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48	A BICLA response required improvement in all domains affected at baseline, assessed by the BILAG 2004, no worsening of other BILAG 2004 domains, no worsening of SLEDAI-2K or PGA scores compared with baseline, no use of restricted medications beyond the protocol-allowed threshold, and no discontinuation of IP.	Week 48

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Score ≥ 10 at Baseline Achieving ≥ 50% Reduction From Baseline in CLASI-A Score at Week 12	The CLASI-A evaluates erythema (0-3 [higher scores indicate more severe redness]), scale/hypertrophy (0-2 [higher scores indicate more extensive scaling/thickening]), mucous membrane lesions (0 [absent] or 1 [present]), recent hair loss (0 [absent] or 1 [present]), and non-scarring alopecia (0-3 [(higher scores indicate more extensive hair loss without scarring]) at 13 anatomical sites on the skin. Total score is calculated by summing scores across all anatomical locations for each parameter. Higher total scores indicate greater disease activity and severity in SLE. Reduction of 50% in CLASI-A score was defined by meeting all the following conditions: A ≥ 50% reduction of CLASI-A score at Week 12 as compared to baseline. No use of restricted medications beyond the protocol-allowed threshold before assessment. No discontinuation of IP.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years to ≤ 70 years
Willing and able to understand and provide written informed consent.
Fulfill the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for SLE
Disease duration of at least 6 months
Active SLE as indicated by presence of all the following:
1. SLEDAI-2K total score ≥ 6 at Screening, excluding fever, SLE headache, or organic brain syndrome.
2. SLEDAI-2K total score ≥ 4, excluding points attributable to any urine or laboratory results, immunologic measures, fever, SLE headache, or organic brain syndrome at Screening and Baseline (Day 1).
3. At least one of the following BILAG 2004 Index levels of disease at Screening:
BILAG A disease in ≥ 1 organ system
BILAG B disease in ≥ 2 organ systems d. PGA score ≥ 1 on a 0 to 3 visual analog scale (VAS) at Screening

Have at least one of the following at Screening per central lab:

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) Ongoing treatment for SLE
1. Treatment with one or more disease-modifying anti-rheumatic drug (DMARD) or immunosuppressive medication: Any of the following medications each administered at conventional anti-rheumatic doses for treatment of SLE for at least 12 weeks before Screening (unless discontinued or dose adjusted for documented drug-related toxicity or size/weight), and at a stable dose (including route of administration) for a minimum of 8 weeks prior to Screening and maintained through Baseline (Day 1):
2. Treatment with OGC monotherapy (without the concomitant use of DMARDs or immunosuppressants):
  - Average daily dose of PO prednisone ≥ 10 mg but ≤ 40 mg (or prednisone equivalent) for a minimum of 4 weeks prior to Screening and a stable dose for minimum of 2 weeks prior to Screening. The dose of OGC must be kept for a minimum of 2 weeks prior to Randomization. Daily dosing or alternate day dosing of PO prednisone or equivalent is allowed.
Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at Randomization.
Non-sterilized male participants who are sexually active with a woman partner of childbearing potential must agree to use a condom with spermicide from Randomization and until 3 months (approximately 5 half-lives) after receipt of the last dose.

Exclusion Criteria:

Any condition that, in the opinion of the Investigator, or the Sponsor/Central Review Committee, would interfere with the evaluation of the IP or interpretation of participant safety or study results (including borderline disease activity)
History of allergy, hypersensitivity reaction, or anaphylaxis to any component of the IP or a previous mAb or human Ig therapy
Active LN or active severe or unstable neuropsychiatric SLE
Current diagnosis of non-SLE vasculitis syndrome, mixed connective tissue disease, or rheumatic (overlap) syndrome
Participation in another clinical study with an investigational drug within 4 weeks before Day 1
Breastfeeding or pregnant women or women who intend to become pregnant anytime from signing the ICF through 6 months after receiving the last dose of IP
Major surgery within 8 weeks prior to Screening or elective surgery planned from Screening through Day 393.
Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks before Screening
Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection
Hepatitis B, Hepatitis C, active TB, any severe herpes infection, clinically active infection, or opportunistic infection
History of clinically significant cardiac disease including unstable angina; and/or myocardial infarction and/or 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-attenuated vaccine within 4 weeks before Day 1 Administration of inactivated (killed) vaccines is acceptable
The use of immunosuppressants, biologics and DMARDS within the protocol defined washout periods

Contacts/Locations Module

Name	Affiliation	Role
MD	Amgen	Study Director
Nisha Jain, MD	Horizon Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Inland Rheumatology Clinical Trials Incorporated		Upland	California	91786	United States
Clinical Research of West Florida Inc - Clearwater

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 matching placebo Q4W SC for a treatment period up to 48 weeks.
FG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.

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	Feb 10, 2022	Jun 7, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Full analysis set (FAS): included all randomized participants who received any dose of investigational product (IP). Participants were analyzed according to the treatment randomized.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
BG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.
BG002	Daxdilimab 200 mg Q12W	Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.
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
	BG00041.0± 11.0 BG00144.5± 13.1 BG00245.3± 11.6 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00067 BG00167 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian or Alaskan Native

Title	Measurements
	BG0002 BG0012 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG00025 BG00127 BG002

Number of Participants Within Each OGC Stratification Dose Level

OGC dose represents the baseline dose of prednisone or any equivalent corticosteroids.

Number

number of participants

Title

Denominators

Categories

< 10 mg/day

Title	Measurements
	BG00036 BG00135

SLEDAI-2K Score

The SLEDAI-2K assessment consists of 24 lupus-related items. It is a weighted instrument, in which descriptors are multiplied by an organ's "weight". For example, renal descriptors are multiplied by 4 and CNS descriptors by 8; these weighted organ manifestations are totalled into the final score. The scores range from 0 to 105, with higher scores indicating more severe disease activity.

Mean

Standard Deviation

Score

Title

Denominators

Categories

Title	Measurements
	BG0009.9± 2.8 BG001

British Isles Lupus Assessment Group (BILAG)-2004 Score

The BILAG-2004 Index assesses lupus disease activity across 9 organ systems. Each organ system is graded from A (severe disease activity requiring urgent treatment; score of 12) to E (system never involved; score of 0). The organ system scores are summed to give an overall score ranging from 0 to 108 where higher scores indicate greater disease activity and severity.

Mean

Standard Deviation

scores on a scale

Title

Denominators

Categories

Title	Measurements
	BG00019.2± 4.7 BG001

Physician Global Assessment (PGA) Score

The PGA takes into account various clinical factors, including the participant's symptoms, physical examination findings, laboratory results, and the physician's judgment. The PGA is scored with a range 0 to 3 where higher scores indicate greater disease activity and severity.

Median

Standard Deviation

Score

Title

Denominators

Categories

Title	Measurements
	BG0001.89± 0.37 BG001

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

Number of Participants Achieving a BILAG-2004 Index-based Combined Lupus Assessment (BICLA) Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48

A BICLA response required improvement in all domains affected at baseline, assessed by the BILAG 2004, no worsening of other BILAG 2004 domains, no worsening of SLEDAI-2K or PGA scores compared with baseline, no use of restricted medications beyond the protocol-allowed threshold, and no discontinuation of IP.

FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized.

Posted

Count of Participants

Participants

Week 48

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
OG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.
OG002	Daxdilimab 200 mg Q12W	Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.

Units	Counts
Participants	OG00064 OG00169 OG00269

Title

Denominators

Categories

Title	Measurements
	OG00025 OG00129 OG00227

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.	Regression, Logistic		=0.7474		Rate Difference	2.8			2-Sided	90	-11.4	17.0					Superiority
OG000 OG002

Secondary

Number of Participants With a Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) Score ≥ 10 at Baseline Achieving ≥ 50% Reduction From Baseline in CLASI-A Score at Week 12

The CLASI-A evaluates erythema (0-3 [higher scores indicate more severe redness]), scale/hypertrophy (0-2 [higher scores indicate more extensive scaling/thickening]), mucous membrane lesions (0 [absent] or 1 [present]), recent hair loss (0 [absent] or 1 [present]), and non-scarring alopecia (0-3 [(higher scores indicate more extensive hair loss without scarring]) at 13 anatomical sites on the skin. Total score is calculated by summing scores across all anatomical locations for each parameter. Higher total scores indicate greater disease activity and severity in SLE. Reduction of 50% in CLASI-A score was defined by meeting all the following conditions:

A ≥ 50% reduction of CLASI-A score at Week 12 as compared to baseline.
No use of restricted medications beyond the protocol-allowed threshold before assessment.
No discontinuation of IP.

FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized. Only participants with a CLASI-A score ≥ 10 at baseline were included in the analysis.

Posted

Count of Participants

Participants

Week 12

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
OG001	Daxdilimab 200 mg Q4W

Secondary

Number of Participants Achieving an SLE Responder Index (SRI)-4 Response and an OGC Dose ≤ 7.5 mg/Day and ≤ Baseline Dose of Prednisone or Equivalent at Week 48

The SRI-4 measures reduction in SLE disease activity and it is a composite measure that includes the SLEDAI-2K, BILAG-2004, and PGA. SRI responder was defined by meeting all of the following criteria: 1) Reduction of ≥4 points from baseline in SLEDAI-2K score; 2) no new BILAG A or no more than 1 new BILAG B disease activity scores and 3) no worsening (defined as an increase of ≥0.3 points [0-3 scale] from baseline) in the PGA.

FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized.

Posted

Count of Participants

Participants

Week 48

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
OG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.
OG002	Daxdilimab 200 mg Q12W	Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.

Secondary

Number of Participants With an OGC Dose ≥ 10 mg/Day of Prednisone or Equivalent at Baseline Who Maintained an OGC Dose ≤ 7.5 mg/Day From Week 36 Through Week 48

Maintenance of OGC reduction from Week 36 to Week 48 was defined by meeting all the following criteria:

Achieved an OGC dose of ≤ 7.5 mg/day prednisone or equivalent at Week 36
Maintained an OGC dose of ≤ 7.5 mg/day from Week 36 through Week 48
No use of restricted medications beyond the protocol-allowed threshold before assessment
No discontinuation of IP before assessment

FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized. Data excludes participants from Russia and Ukraine sites. Only participants with an OGC dose ≥ 10 mg/day of prednisone or equivalent at baseline were included in the analysis.

Posted

Count of Participants

Participants

Week 36 up to Week 48

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
OG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.
OG002	Daxdilimab 200 mg Q12W

Secondary

Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48

LLDAS was defined by meeting all of the following criteria:

SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System
No new lupus disease activity compared with the previous
Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity
A current prednisolone (or equivalent) dose ≤ 7.5 mg daily
Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents

FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized.

Posted

Count of Participants

Participants

Week 48

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
OG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.
OG002

Secondary

Serum Concentration of Daxdilimab

Pharmacokinetic (PK) analysis set: included all participants who received any dose of daxdilimab in the study and had at least 1 quantifiable serum PK observation post-first dose. Participants were analyzed according to the treatment that they received.

Posted

Mean

Standard Deviation

ug/mL

Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28, Week 32, Week 36, Week 40, Week 44, Week 48

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
OG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.
OG002	Daxdilimab 200 mg Q12W	Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.

Units	Counts
Participants

Secondary

Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab

A baseline ADA-positive participant was defined as a participant who had an ADA positive sample at baseline. ADA incidence is the number of the participants ADA positive post-Baseline only or who boosted their preexisting ADA (≥ 4 × Baseline level) 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.

Safety analysis set (SAS): included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received.

Posted

Count of Participants

Participants

Baseline to Week 56

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
OG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.
OG002	Daxdilimab 200 mg Q12W	Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.

Secondary

Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood

SAS: included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received. Only participants with available data were included in the analysis.

Posted

Mean

Standard Deviation

cells/uL

Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 44, Week 48, Week 52, Week 56

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
OG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.
OG002	Daxdilimab 200 mg Q12W	Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.

Units	Counts
Participants

Secondary

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

An adverse event (AE) is any untoward medical occurrence associated with the use of an intervention in humans whether or not it is considered intervention-related. TEAEs are AEs that started on or after the first dose of IP. An AE was considered serious (SAE) if it resulted in any of the following outcomes: death, a life-threatening AE, inpatient hospitalization or prolonged existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital abnormality/birth defect, or an important medical event. AE severity was rated according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).

SAS: included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received.

Posted

Count of Participants

Participants

Up to Week 56

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
OG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.
OG002

Secondary

Number of Participants Who Experienced AEs of Special Interest (AESI)

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. AESIs for this study included:

Hypersensitivity reaction, including anaphylaxis.
Severe (Grade 3 or higher) viral infections/reactivations.
Opportunistic infection.
Malignancy (except non-melanoma skin cancer).

SAS: included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received.

Posted

Count of Participants

Participants

Up to Week 56

ID	Title	Description
OG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.
OG001	Daxdilimab 200 mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.
OG002	Daxdilimab 200 mg Q12W	Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks.	0	71	8	71	17	71
EG001	Daxdilimab 200mg Q4W	Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks.	1	72	9	72	30	72
EG002	Daxdilimab 200mg Q12W	Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.	0	71	9	71	29	71

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected71 at risk EG0010 affected72 at risk EG0020 affected71 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected72 at risk EG0021 affected71 at risk
Angina pectoris	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0020 affected71 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0020 affected71 at risk
Pericardial effusion	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0020 affected71 at risk
Huntington's disease	Congenital, familial and genetic disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected72 at risk EG0021 affected71 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected72 at risk EG0021 affected71 at risk
Colitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected71 at risk EG0010 affected72 at risk EG0020 affected71 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0020 affected71 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected72 at risk EG0021 affected71 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0020 affected71 at risk
Appendicitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 affected71 at risk EG0010 affected72 at risk EG0020 affected71 at risk
Herpes zoster	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0020 affected71 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0021 affected71 at risk
Abortion induced incomplete	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected72 at risk EG0021 affected71 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected72 at risk EG0021 affected71 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected71 at risk EG0010 affected72 at risk EG0020 affected71 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected71 at risk EG0010 affected72 at risk EG0020 affected71 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected72 at risk EG0021 affected71 at risk
Systemic lupus erythematosus	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected71 at risk EG0011 affected72 at risk EG0020 affected71 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0021 affected71 at risk
Loss of consciousness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected72 at risk EG0021 affected71 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected71 at risk EG0010 affected72 at risk EG0020 affected71 at risk
Hydrosalpinx	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0010 affected72 at risk EG0021 affected71 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0020 affected71 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0020 affected71 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0011 affected72 at risk EG0020 affected71 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0014 affected72 at risk EG0020 affected71 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected71 at risk EG0014 affected72 at risk EG0022 affected71 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected71 at risk EG0010 affected72 at risk EG0024 affected71 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0009 affected71 at risk EG00110 affected72 at risk EG0029 affected71 at risk
Influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected71 at risk EG0014 affected72 at risk EG0022 affected71 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0004 affected71 at risk EG0013 affected72 at risk EG0022 affected71 at risk
Sinusitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected71 at risk EG0014 affected72 at risk EG0022 affected71 at risk
Upper respiratory tract infection bacterial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 affected71 at risk EG0011 affected72 at risk EG0024 affected71 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0004 affected71 at risk EG0017 affected72 at risk EG0028 affected71 at risk
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0005 affected71 at risk EG0013 affected72 at risk EG0021 affected71 at risk

First MCP Posted Date

ID	Term
D008180	Lupus Erythematosus, Systemic

Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.

Participants were randomized to receive daxdilimab 200 mg Q12W (with an additional 200 mg SC dose at Week 4) for a treatment period up to 48 weeks.

Units	Counts
Participants	OG00071 OG00172 OG00271

OG001-1.4240± 1.9493

OG002-1.2903± 1.2201

OG001-1.5194± 1.7555

OG002-1.1486± 1.2090

OG001-1.5164± 1.8180

OG002-1.1134± 1.5290

OG001-1.5131± 1.6837

OG002-1.0320± 1.1063

OG001-1.5974± 1.7705

OG002-0.5507± 1.3090

OG001-1.3367± 1.5678

OG002-0.8496± 1.2403

OG001-1.4614± 1.7634

OG002-0.9131± 0.9845

OG001-1.6540± 1.6184

OG002-1.1322± 1.3782

OG001-1.4608± 1.5647

OG002-0.7964± 1.0055

OG001-0.4353± 0.5127

OG0020.0149± 0.7999

OG001-2.3137± 3.2514

OG002-0.7056± 0.6729

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases