Lupus Erythematosus, Systemic
Conditions
Brief summary
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of VIB7734 for the Treatment of Moderate to Severely Active Systemic Lupus Erythematosus in approximately 195 participants. The study duration will be 48 weeks, with a safety follow-up through week 56.There will be 3 parallel arms - 2 active treatment and 1 placebo.
Interventions
DRUGVIB7734
VIB7734
OTHERPlacebo
Placebo
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, double-blind, placebo-controlled, parallel-arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | Week 36 up to Week 48 | Maintenance of OGC reduction from Week 36 to Week 48 was defined by meeting all the following criteria: 1. Achieved an OGC dose of ≤ 7.5 mg/day prednisone or equivalent at Week 36 2. Maintained an OGC dose of ≤ 7.5 mg/day from Week 36 through Week 48 3. No use of restricted medications beyond the protocol-allowed threshold before assessment 4. No discontinuation of IP before assessment |
| Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48 | Week 48 | LLDAS was defined by meeting all of the following criteria: 1. 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 2. No new lupus disease activity compared with the previous 3. Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity 4. A current prednisolone (or equivalent) dose ≤ 7.5 mg daily 5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents |
| Serum Concentration of Daxdilimab | 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 | — |
| 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 | 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: 1. A ≥ 50% reduction of CLASI-A score at Week 12 as compared to baseline. 2. No use of restricted medications beyond the protocol-allowed threshold before assessment. 3. No discontinuation of IP. |
| Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 44, Week 48, Week 52, Week 56 | — |
| Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Up to Week 56 | 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). |
| Number of Participants Who Experienced AEs of Special Interest (AESI) | Up to Week 56 | 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: 1. Hypersensitivity reaction, including anaphylaxis. 2. Severe (Grade 3 or higher) viral infections/reactivations. 3. Opportunistic infection. 4. Malignancy (except non-melanoma skin cancer). |
| Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Baseline to Week 56 | 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. |
Countries
Argentina, Greece, India, Mexico, Poland, Russia, Serbia, Spain, Taiwan, Ukraine, United States
Participant flow
Recruitment details
Participants with systemic lupus erythematosus (SLE) were enrolled at 68 sites in the United States, Argentina, Greece, India, Mexico, Poland, Serbia, Spain, Taiwan, Ukraine and Russia between May 2021 and June 2023.
Pre-assignment details
Participants were randomized in a 1:1:1 ratio to take daxdilimab 200 mg every 4 weeks (Q4W) subcutaneously (SC), daxdilimab 200 mg every 12 weeks (Q12W) SC (with an additional 200 mg SC dose at Week 4) or matching placebo Q4W SC. Duration of treatment was up to 48 weeks. Randomization was stratified by SLE Disease Activity Index 2000 (SLEDAI-2K) total score at screening (≥ 10 or \< 10) and prednisone or equivalent oral glucocorticoid (OGC) dose at baseline (≥ 10 mg/day or \< 10 mg/day).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were randomized to receive matching placebo Q4W SC for a treatment period up to 48 weeks. | 71 |
| Daxdilimab 200 mg Q4W Participants were randomized to receive daxdilimab 200 mg Q4W for a treatment period up to 48 weeks. | 72 |
| 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. | 71 |
| Total | 214 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 |
| Overall Study | Death | 0 | 1 | 0 |
| Overall Study | Eastern European Conflict | 7 | 3 | 2 |
| Overall Study | Lost to Follow-up | 2 | 0 | 1 |
| Overall Study | Other | 2 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 8 | 5 | 9 |
Baseline characteristics
| Characteristic | Placebo | Total | Daxdilimab 200 mg Q12W | Daxdilimab 200 mg Q4W |
|---|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 11 | 43.6 years STANDARD_DEVIATION 12 | 45.3 years STANDARD_DEVIATION 11.6 | 44.5 years STANDARD_DEVIATION 13.1 |
| British Isles Lupus Assessment Group (BILAG)-2004 Score | 19.2 scores on a scale STANDARD_DEVIATION 4.7 | 19.5 scores on a scale STANDARD_DEVIATION 4.9 | 19.8 scores on a scale STANDARD_DEVIATION 5.5 | 19.5 scores on a scale STANDARD_DEVIATION 4.6 |
| Number of Participants Within Each OGC Stratification Dose Level < 10 mg/day | 36 number of participants | 107 number of participants | 36 number of participants | 35 number of participants |
| Number of Participants Within Each OGC Stratification Dose Level ≥ 10 mg/day | 35 number of participants | 107 number of participants | 35 number of participants | 37 number of participants |
| Physician Global Assessment (PGA) Score | 1.89 Score STANDARD_DEVIATION 0.37 | 1.91 Score STANDARD_DEVIATION 0.37 | 1.90 Score STANDARD_DEVIATION 0.41 | 1.96 Score STANDARD_DEVIATION 0.32 |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 2 participants | 4 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 9 participants | 26 participants | 10 participants | 7 participants |
| Race/Ethnicity, Customized Black or African American | 4 participants | 18 participants | 6 participants | 8 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 25 participants | 79 participants | 27 participants | 27 participants |
| Race/Ethnicity, Customized Multiple categories checked | 1 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 46 participants | 135 participants | 44 participants | 45 participants |
| Race/Ethnicity, Customized Other | 1 participants | 11 participants | 4 participants | 6 participants |
| Race/Ethnicity, Customized White | 54 participants | 154 participants | 51 participants | 49 participants |
| Sex: Female, Male Female | 67 Participants | 200 Participants | 66 Participants | 67 Participants |
| Sex: Female, Male Male | 4 Participants | 14 Participants | 5 Participants | 5 Participants |
| SLEDAI-2K Score | 9.9 Score STANDARD_DEVIATION 2.8 | 10.2 Score STANDARD_DEVIATION 3.3 | 10.1 Score STANDARD_DEVIATION 2.9 | 10.6 Score STANDARD_DEVIATION 4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 1 / 72 | 0 / 71 |
| other Total, other adverse events | 17 / 71 | 30 / 72 | 29 / 71 |
| serious Total, serious adverse events | 8 / 71 | 9 / 72 | 9 / 71 |
Outcome results
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.
Time frame: Week 48
Population: FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | 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 | 25 Participants |
| Daxdilimab 200 mg Q4W | 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 | 29 Participants |
| Daxdilimab 200 mg Q12W | 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 | 27 Participants |
Comparison: Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.p-value: =0.747490% CI: [-11.4, 17]Regression, Logistic
Comparison: Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.p-value: =0.994290% CI: [-14.2, 14.1]Regression, Logistic
Secondary
Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood
Time frame: Baseline, Week 4, Week 8, Week 12, Week 20, Week 24, Week 32, Week 36, Week 44, Week 48, Week 52, Week 56
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 12 | 0.0275 cells/uL | Standard Deviation 1.758 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 44 | -0.3194 cells/uL | Standard Deviation 1.6347 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 4 | -0.2324 cells/uL | Standard Deviation 1.8194 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 48 | 0.1973 cells/uL | Standard Deviation 2.4112 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 52 | 0.1483 cells/uL | Standard Deviation 3.7955 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 56 | -2.0823 cells/uL | Standard Deviation 3.9807 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 20 | 285.1519 cells/uL | Standard Deviation 1613.566 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Baseline | 2.5068 cells/uL | Standard Deviation 1.8486 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 8 | -0.4608 cells/uL | Standard Deviation 1.4125 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 24 | -0.3911 cells/uL | Standard Deviation 1.7344 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 32 | 0.3513 cells/uL | Standard Deviation 1.7855 |
| Placebo | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 36 | -0.1274 cells/uL | Standard Deviation 1.6962 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 32 | -1.3367 cells/uL | Standard Deviation 1.5678 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 8 | -1.5194 cells/uL | Standard Deviation 1.7555 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 44 | -1.6540 cells/uL | Standard Deviation 1.6184 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 20 | -1.5131 cells/uL | Standard Deviation 1.6837 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 48 | -1.4608 cells/uL | Standard Deviation 1.5647 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Baseline | 2.2960 cells/uL | Standard Deviation 1.7457 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 52 | -0.4353 cells/uL | Standard Deviation 0.5127 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 4 | -1.4240 cells/uL | Standard Deviation 1.9493 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 24 | -1.5974 cells/uL | Standard Deviation 1.7705 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 56 | -2.3137 cells/uL | Standard Deviation 3.2514 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 12 | -1.5164 cells/uL | Standard Deviation 1.818 |
| Daxdilimab 200 mg Q4W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 36 | -1.4614 cells/uL | Standard Deviation 1.7634 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 24 | -0.5507 cells/uL | Standard Deviation 1.309 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 12 | -1.1134 cells/uL | Standard Deviation 1.529 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 48 | -0.7964 cells/uL | Standard Deviation 1.0055 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Baseline | 1.9195 cells/uL | Standard Deviation 1.199 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 4 | -1.2903 cells/uL | Standard Deviation 1.2201 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 20 | -1.0320 cells/uL | Standard Deviation 1.1063 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 8 | -1.1486 cells/uL | Standard Deviation 1.209 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 32 | -0.8496 cells/uL | Standard Deviation 1.2403 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 36 | -0.9131 cells/uL | Standard Deviation 0.9845 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 44 | -1.1322 cells/uL | Standard Deviation 1.3782 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 52 | 0.0149 cells/uL | Standard Deviation 0.7999 |
| Daxdilimab 200 mg Q12W | Change From Baseline in Plasmacytoid Dendritic Cell (pDCs) Expression in Blood | Week 56 | -0.7056 cells/uL | Standard Deviation 0.6729 |
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.
Time frame: Week 48
Population: FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | 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 | 26 Participants |
| Daxdilimab 200 mg Q4W | 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 | 34 Participants |
| Daxdilimab 200 mg Q12W | 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 | 30 Participants |
Comparison: Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.p-value: =0.32290% CI: [-5.6, 22.7]Regression, Logistic
Comparison: Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.p-value: =0.736490% CI: [-11.2, 17]Regression, Logistic
Secondary
Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48
LLDAS was defined by meeting all of the following criteria: 1. 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 2. No new lupus disease activity compared with the previous 3. Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity 4. A current prednisolone (or equivalent) dose ≤ 7.5 mg daily 5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents
Time frame: Week 48
Population: FAS: included all randomized participants who received any dose of IP. Participants were analyzed according to the treatment randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48 | 11 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48 | 23 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 48 | 15 Participants |
Comparison: Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.p-value: =0.03790% CI: [4, 29]Regression, Logistic
Comparison: Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment and randomization stratification factors in the model.p-value: =0.493990% CI: [-6.7, 16.4]Regression, Logistic
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: 1. Hypersensitivity reaction, including anaphylaxis. 2. Severe (Grade 3 or higher) viral infections/reactivations. 3. Opportunistic infection. 4. Malignancy (except non-melanoma skin cancer).
Time frame: Up to Week 56
Population: SAS: included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Experienced AEs of Special Interest (AESI) | Opportunistic infection | 1 Participants |
| Placebo | Number of Participants Who Experienced AEs of Special Interest (AESI) | Hypersensitivity Reaction Including Anaphylaxis | 1 Participants |
| Placebo | Number of Participants Who Experienced AEs of Special Interest (AESI) | Viral infection/Reactivation | 10 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants Who Experienced AEs of Special Interest (AESI) | Opportunistic infection | 1 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants Who Experienced AEs of Special Interest (AESI) | Hypersensitivity Reaction Including Anaphylaxis | 0 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants Who Experienced AEs of Special Interest (AESI) | Viral infection/Reactivation | 6 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants Who Experienced AEs of Special Interest (AESI) | Hypersensitivity Reaction Including Anaphylaxis | 1 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants Who Experienced AEs of Special Interest (AESI) | Viral infection/Reactivation | 7 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants Who Experienced AEs of Special Interest (AESI) | Opportunistic infection | 1 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).
Time frame: Up to Week 56
Population: SAS: included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs | 49 Participants |
| Placebo | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Treatment-related TEAEs | 10 Participants |
| Placebo | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | AEs Grade 3 or higher | 5 Participants |
| Placebo | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs | 8 Participants |
| Placebo | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAEs | 0 Participants |
| Placebo | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | AEs Resulting in Death | 0 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | AEs Resulting in Death | 1 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs | 49 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs | 9 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAEs | 1 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Treatment-related TEAEs | 17 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | AEs Grade 3 or higher | 8 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Treatment-related TEAEs | 17 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | AEs Grade 3 or higher | 9 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | AEs Resulting in Death | 0 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | SAEs | 9 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | TEAEs | 58 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) | Treatment-related SAEs | 0 Participants |
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: 1. A ≥ 50% reduction of CLASI-A score at Week 12 as compared to baseline. 2. No use of restricted medications beyond the protocol-allowed threshold before assessment. 3. No discontinuation of IP.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | 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 | 1 Participants |
| Daxdilimab 200 mg Q4W | 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 | 4 Participants |
| Daxdilimab 200 mg Q12W | 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 | 5 Participants |
Comparison: Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.p-value: =0.162690% CI: [-0.3, 74.7]Regression, Logistic
Comparison: Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, randomization stratification factors and Baseline CLASI-A score in the model.p-value: =0.287390% CI: [-7.5, 55.8]Regression, Logistic
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: 1. Achieved an OGC dose of ≤ 7.5 mg/day prednisone or equivalent at Week 36 2. Maintained an OGC dose of ≤ 7.5 mg/day from Week 36 through Week 48 3. No use of restricted medications beyond the protocol-allowed threshold before assessment 4. No discontinuation of IP before assessment
Time frame: Week 36 up to Week 48
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | 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 | 20 Participants |
| Daxdilimab 200 mg Q4W | 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 | 27 Participants |
| Daxdilimab 200 mg Q12W | 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 | 26 Participants |
Comparison: Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.p-value: =0.280590% CI: [-6.1, 29.4]Regression, Logistic
Comparison: Adjusted response rate, rate difference and p-value are from logistic regression analysis with treatment, stratification factors (SLEDAI-2K only) and Baseline OGC dose included in the model.p-value: =0.392690% CI: [-8.6, 27.3]Regression, Logistic
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.
Time frame: Baseline to Week 56
Population: Safety analysis set (SAS): included all participants who received any dose of IP. Participants were analyzed according to the treatment that they received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Both Baseline and post-Baseline positive | 10 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | ADA not detected (negative) on trial | 47 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Only post-Baseline positive | 13 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Only Baseline positive | 1 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | ADA incidence | 14 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Transient positive | 4 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Persistent positive | 19 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Boosted ADA (≥ 4 × Baseline level) | 1 Participants |
| Placebo | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | ADA detected (positive) on trial: ADA prevalence | 24 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | ADA not detected (negative) on trial | 59 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | ADA incidence | 6 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Boosted ADA (≥ 4 × Baseline level) | 2 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | ADA detected (positive) on trial: ADA prevalence | 13 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Only Baseline positive | 5 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Only post-Baseline positive | 4 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Both Baseline and post-Baseline positive | 4 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Persistent positive | 8 Participants |
| Daxdilimab 200 mg Q4W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Transient positive | 0 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Boosted ADA (≥ 4 × Baseline level) | 2 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | ADA not detected (negative) on trial | 56 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Both Baseline and post-Baseline positive | 6 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | ADA incidence | 6 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Transient positive | 2 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Only Baseline positive | 5 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | ADA detected (positive) on trial: ADA prevalence | 15 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Persistent positive | 8 Participants |
| Daxdilimab 200 mg Q12W | Number of Participants With Anti-drug Antibodies (ADA) to Daxdilimab | Only post-Baseline positive | 4 Participants |
Secondary
Serum Concentration of Daxdilimab
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 20 | 5.884 ug/mL | Standard Deviation 4.451 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 24 | 5.539 ug/mL | Standard Deviation 4.224 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 28 | 4.855 ug/mL | Standard Deviation 3.743 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 32 | 4.951 ug/mL | Standard Deviation 4.047 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 36 | 5.321 ug/mL | Standard Deviation 4.309 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 40 | 4.652 ug/mL | Standard Deviation 3.426 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 44 | 4.908 ug/mL | Standard Deviation 3.78 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 48 | 5.543 ug/mL | Standard Deviation 4.637 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 4 | 3.319 ug/mL | Standard Deviation 1.972 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 8 | 4.714 ug/mL | Standard Deviation 3.079 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 12 | 5.344 ug/mL | Standard Deviation 3.624 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Week 16 | 5.035 ug/mL | Standard Deviation 3.377 |
| Daxdilimab 200 mg Q4W | Serum Concentration of Daxdilimab | Baseline | 0.011 ug/mL | Standard Deviation 0.026 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 12 | 1.372 ug/mL | Standard Deviation 1.189 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Baseline | 0.008 ug/mL | Standard Deviation 0.004 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 20 | 1.239 ug/mL | Standard Deviation 1.097 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 44 | 1.115 ug/mL | Standard Deviation 1.378 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 24 | 0.530 ug/mL | Standard Deviation 0.922 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 8 | 4.643 ug/mL | Standard Deviation 2.708 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 28 | 3.590 ug/mL | Standard Deviation 2.522 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 48 | 0.406 ug/mL | Standard Deviation 0.585 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 32 | 1.096 ug/mL | Standard Deviation 1.151 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 16 | 4.268 ug/mL | Standard Deviation 2.72 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 36 | 0.366 ug/mL | Standard Deviation 0.471 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 4 | 3.301 ug/mL | Standard Deviation 1.718 |
| Daxdilimab 200 mg Q12W | Serum Concentration of Daxdilimab | Week 40 | 3.439 ug/mL | Standard Deviation 2.534 |