Lupus Nephritis, Systemic Lupus Erythematosus
Conditions
Keywords
SLE, Lupus, BELONG
Brief summary
This is a Phase III, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to SOC (corticosteroid plus one of two immunosuppressant regimens) compared with placebo added to SOC in patients with WHO or ISN Class III or IV lupus nephritis.
Interventions
DRUGCorticosteroids
Intravenous and oral repeating dose
DRUGCyclophosphamide
Cyclophosphamide was administered at a IV dose 500 mg every 2 weeks for up to 6 doses followed by maintenance treatment with azathioprine.
DRUGMycophenolate Mofetil
Mycophenolate Mofetil was administered orally at maximum dose of 3 g/day.
DRUGOcrelizumab
Ocrelizumab was administed at a dose and as per schedule in arm description
DRUGPlacebo
Placebo was administered as per schedule in arm description
DRUGAzathioprine
Azathioprine was administered at a dose up to 2 mg/kg/day with a maximum dose of 200 mg.
Sponsors
Roche Pharma AG
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 16 years or above at the time of the screening * Ability and willingness to provide written informed consent and to comply with the schedule of protocol requirements * Diagnosis of SLE * Active lupus nephritis
Exclusion criteria
* Currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia * Severe renal impairment * Lack of peripheral venous access * Pregnancy or breast feeding mothers * History of severe allergic or anaphylactic reactions to humanized, chimeric or murine monoclonal antibodies or i.v. immunoglobulin * Known severe chronic pulmonary disease * Evidence of significant uncontrolled concomitant diseases in any organ system not related to SLE, which, in the investigator's opinion, would preclude patient participation * Concomitant condition which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) prior to screening * Known HIV or chronic active Hepatitis B or chronic active Hepatitis C infection * Known active infection of any kind prior to Day 1 * History of serious recurrent or chronic infection * History of cancer, including solid tumors, hematological malignancies and carcinoma in situ (except basal cell carcinoma of the skin that has been excised and cured). * History of alcohol or drug abuse prior to screening * Major surgery prior to screening, excluding diagnostic surgery * Previous treatment with CAMPATH-1H * Previous treatment with a BAFF directed treatment (e.g. anti-BLyS) prior to screening * Previous treatment with a B-cell targeted therapy other than one directed at BAFF (e.g. anti-CD20, anti-CD22) * Treatment with any investigational agent prior to screening * Receipt of any live vaccines prior to Day 1 * Intolerance or contraindication to oral or i.v. corticosteroids * Positive hepatitis BsAg or hepatitis C serology. Patients who are HBsAg negative but HBcAb positive may be enrolled with a negative DNA test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved Complete Renal Response (CRR) | Week 48 | CRR was defined as: 1. Normal serum creatinine (and with no more than a 25 percent \[%\] increase from Baseline); 2. Improvement in urinary protein:urinary creatinine ratio to less than or equal to (≤) 0.5. PRR was defined as at least 50 percent (%) reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio was greater than (\>) 3, a urine protein:urine creatinine ratio of less than (\<) 3 needed to be achieved. |
| Percentage of Participants Who Achieved Overall Response | Week 48 | Overall response rate (ORR) equals (=) CRR + PRR. CRR was defined as: 1. Normal serum creatinine (and with no more than a 25% increase from baseline) 2. Improvement in urinary protein:urinary creatinine ratio to ≤0.5. PRR was defined as at least 50 % reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio is \>3, a urine protein:urine creatinine ratio of \<3 needs to be achieved. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC) of Calculated Glomerular Filtration Rate (cGFR) Between Baseline and Week 48 | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48 | The improvement of AUC of cGFR was to be measured between Baseline and Week 48. This was to be analyzed with Analysis of Covariance (ANCOVA) with race and SOC as covariates. |
| Percentage of Participants Who Achieved A Reduction In Systemic Lupus Erythematosis Disease Activity Index (SLEDAI) -2K Score | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | SLEDAI-2K measures disease activity at the visit or within the preceding 10 days. It comprised of 24 descriptors, covering 9 organ systems, and reflects disease activity over the previous 10 days.The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity |
| Time to First Renal Flare In Those Participants Who Demonstrated at Least a Partial Renal Response | Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Renal flares may be either proteinuric or nephritic as defined below: Proteinuric Flares are defined as follows:In participants who achieve a urine protein:urine creatinine (Upr:Ucr) ≤ 0.5, an increase to Upr:Ucr \>1; In participants with an Upr:Ucr \>0.5, a doubling of Upr:Ucr (with a minimum increase to Upr:Ucr \>2). Nephritic Flare defined as: Increase in serum creatinine of ≥30% from the lowest value achieved in the study accompanied by Increase Upr:Ucr \>1 Or New/worsening active urine sediment on two consecutive occasions, in the absence of urinary tract infection or other causes of hematuria. |
| Percentage of Participants Who Achieved Clinically Meaningful Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF36) From Baseline to Week 48 | Baseline and Weeks 1, 12, 24, 36, and 48 | The SF36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions physical role functioning, emotional role functioning, social role functioning, and mental health. |
| Percentage of Participants Who Achieved Clinically Meaningful Improvement in Fatigue Using the Functional Assessment of Chronic Illness Therapy (Facit) Fatigue Questionnaire From Baseline to Week 48 | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | The FACIT Fatigue Scale is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). |
| Percentage of Participants Who Achieved Clinically Meaningful Improvement in Pain Using the Modified Brief Pain Inventory Short Form (mBPI-SF) From Baseline to Week 48 | Baseline and Weeks 1, 12, 24, 36, and 48 | m-BPI-sf is a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours with a range of 0 (no pain) to 10 (worst imaginable pain). |
| Health Care Visits Over the 48-Week Treatment Period | Weeks 1, 24, and 48 | The number of health care visits (including doctor's office visits, Emergency room/ Accident and Emergency \[ER/A&E\] visits and hospitalizations) over the 48-week treatment period were recorded. |
| Percentage of Participants Who Achieved a CRR or PRR And Who Received A Corticosteroid Dose of <10 Milligrams Per Day (mg/Day) From Week 24 to Week 48 | Week 48 | CRR was defined as: 1. Normal serum creatinine (and with no more than a 25% increase from Baseline) 2. Inactive urinary sediment 3. Improvement in urinary protein:urinary creatinine ratio to ≤0.5. PRR was defined as at least 50% reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio was \>3, a urine protein:urine creatinine ratio of \<3 needed to be achieved. |
| Percentage of Participants Who Achieved a Renal Response (Partial or Complete) by Week 36, and Sustain or Improve This Response Until Week 48 | Weeks 36, 40, 44, and 48 | — |
| Average Corticosteroid Burden Measured by AUC of the Cumulative Corticosteroid Dose Between 16 and 48 Weeks | Weeks 16, 20, 24, 28, 32, 36, 40, 44, and 48 | AUC is the area under the curve (mathematically known as definite integral) in a plot of concentration of drug in blood plasma against time. AUC was to be used to determine the average corticosteroid burden. |
| Percentage of Participants Who Stopped Immunosuppressants After Week 48 | Week 48 | The number of participants who stopped immunosuppressants were to be determined by survey. |
| Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32 | CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. CD19+ cells were measured as cells per microliter (cells/uL). |
| Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32 | CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. 0 represents 0% of participants. |
| Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32 | CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. n = number of participants analyzed at the specified visit. 0 represents 0% of participants. |
| Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32 | CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. \<LLN = 80 cells/uL. |
| Percentage of Participants Achieving a Major Clinical Response or a Partial Clinical Response | Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | A major clinical response was defined as British Isles Lupus Assessment Group (BILAG) C scores or better at Week 24 without developing any new A or two new B scores up to Week 24 and maintenance of this response without developing a moderate or severe flare between Week 24 and Week 48. A partial clinical response was defined as BILAG C scores or better at Week 24 and maintaining this response without developing a flare for 16 consecutive weeks. The BILAG is an organ-specific 86-question assessment based on the principle of the doctor's intent to treat, which requires an assessment of improved (1), the same (2), worse (3), or new (4) over the last month. Within each organ system, multiple manifestations and laboratory tests are combined into a single score for that organ. The resulting scores for each organ can be A through E, where A is very active disease, B is moderate activity, C is mild stable disease, D is resolved activity, and E indicates the organ was never involved. |
| Percentage of Participants Who Achieved a CRR or PRR And Who Received a Corticosteroid Dose of <5 mg/Day by Week 48 | Week 48 | CRR was defined as: 1. Normal serum creatinine (and with no more than a 25% increase from Baseline) 2. Inactive urinary sediment 3. Improvement in urinary protein:urinary creatinine ratio to ≤0.5. PRR was defined as at least 50% reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio was \>3, a urine protein: urine creatinine ratio of \<3 needed to be achieved. |
| Time To Complete Renal Response | Baseline up to Week 48 | Time to complete renal response was proposed to be analyzed using a stratified log rank test with race and SOC as stratification factors. Comparisons of ocrelizumab versus placebo were to be expressed as p-values, estimated hazard ratios, adjusted proportions of participants who achieved a complete renal response and their 95% confidence intervals. Kaplan-Meier curves were to be produced. Due to early termination of the study the analyses were not performed. |
Participant flow
Recruitment details
Screening was done from Day -14 to Day -1.
Participants by arm
| Arm | Count |
|---|---|
| OCR 400 mg + SOC Participants received 400 mg ocrelizumab IV on Days 1 and 15, followed by 400 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day \[mg/kg/day\]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day. | 127 |
| OCR 1000 mg + SOC Participants received 1000 mg ocrelizumab IV on Days 1 and 15, followed by 1000 mg ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day \[mg/kg/day\]), or MMF 1 g/day in the first week increased to 3 g/day. Participants also received methylprednisolone 100 mg infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of ocrelizumab. Participants also received oral prednisone at starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day. | 128 |
| Placebo + SOC Participants received placebo matched to ocrelizumab infusion intravenously (IV) on Days 1 and 15, followed by placebo matched to ocrelizumab infusion IV on Week 16 and then every 16 weeks up to 48 weeks along with one of the two standard-of-care (SOC) immunosuppressant regimens at the discretion of the investigator. The SOC regimens were: Euro-Lupus (cyclophosphamide 500 mg every 2 weeks for 6 doses followed by azathioprine maintenance at 1-2 milligrams per kilogram per day \[mg/kg/day\]), or mycophenolate mofetil (MMF) 1 grams per day (g/day) in the first week increased to 3 g/day. Participants also received methylprednisolone 100 milligram (mg) infusion IV or according to local guidelines, completed at least 30 minutes prior to each infusion of placebo. Participants also received oral prednisone at a starting dose of 0.75 mg/kg/day with a maximum dose of 60 mg/day from Day 2. Beginning on Day 16 the doses were tapered and continued for 10 weeks to a target dose of 10 mg/day. | 126 |
| Total | 381 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative reasons | 15 | 19 | 55 |
| Overall Study | Adverse Event | 1 | 1 | 2 |
| Overall Study | Adverse event, serious fatal | 3 | 6 | 6 |
| Overall Study | Did not cooperate | 2 | 6 | 1 |
| Overall Study | Failure to return | 6 | 5 | 6 |
| Overall Study | Withdrawal by Subject | 17 | 17 | 7 |
Baseline characteristics
| Characteristic | Placebo + SOC | Total | OCR 400 mg + SOC | OCR 1000 mg + SOC |
|---|---|---|---|---|
| Age, Continuous | 31.3 Years STANDARD_DEVIATION 9.9 | 31.3 Years STANDARD_DEVIATION 9.7 | 31.9 Years STANDARD_DEVIATION 10.2 | 30.6 Years STANDARD_DEVIATION 8.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 17 Participants | 49 Participants | 17 Participants | 15 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 101 Participants | 39 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 19 Participants | 7 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 32 Participants | 9 Participants | 12 Participants |
| Race (NIH/OMB) White | 58 Participants | 180 Participants | 55 Participants | 67 Participants |
| Sex: Female, Male Female | 107 Participants | 332 Participants | 115 Participants | 110 Participants |
| Sex: Female, Male Male | 19 Participants | 49 Participants | 12 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 125 | 6 / 127 | 3 / 126 |
| other Total, other adverse events | 96 / 125 | 91 / 127 | 101 / 126 |
| serious Total, serious adverse events | 36 / 125 | 38 / 127 | 53 / 126 |
Outcome results
Primary
Number of Participants Who Achieved Complete Renal Response (CRR)
CRR was defined as: 1. Normal serum creatinine (and with no more than a 25 percent \[%\] increase from Baseline); 2. Improvement in urinary protein:urinary creatinine ratio to less than or equal to (≤) 0.5. PRR was defined as at least 50 percent (%) reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio was greater than (\>) 3, a urine protein:urine creatinine ratio of less than (\<) 3 needed to be achieved.
Time frame: Week 48
Population: The primary endpoint was analyzed via an overall response (CRR+PRR) analysis and the separate complete and partial response rates were only summarized descriptively
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OCR 400 mg + SOC | Number of Participants Who Achieved Complete Renal Response (CRR) | CRR | 42.7 Percentage of Participants |
| OCR 400 mg + SOC | Number of Participants Who Achieved Complete Renal Response (CRR) | PRR | 24 Percentage of Participants |
| OCR 1000 mg + SOC | Number of Participants Who Achieved Complete Renal Response (CRR) | CRR | 31.5 Percentage of Participants |
| OCR 1000 mg + SOC | Number of Participants Who Achieved Complete Renal Response (CRR) | PRR | 35.6 Percentage of Participants |
| Placebo + SOC | Number of Participants Who Achieved Complete Renal Response (CRR) | PRR | 20 Percentage of Participants |
| Placebo + SOC | Number of Participants Who Achieved Complete Renal Response (CRR) | CRR | 34.7 Percentage of Participants |
Primary
Percentage of Participants Who Achieved Overall Response
Overall response rate (ORR) equals (=) CRR + PRR. CRR was defined as: 1. Normal serum creatinine (and with no more than a 25% increase from baseline) 2. Improvement in urinary protein:urinary creatinine ratio to ≤0.5. PRR was defined as at least 50 % reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio is \>3, a urine protein:urine creatinine ratio of \<3 needs to be achieved.
Time frame: Week 48
Population: The primary endpoint was analyzed via an overall response (CRR+PRR) analysis and the separate complete and partial response rates were only summarized descriptively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OCR 400 mg + SOC | Percentage of Participants Who Achieved Overall Response | 66.7 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants Who Achieved Overall Response | 67.1 Percentage of Participants |
| Placebo + SOC | Percentage of Participants Who Achieved Overall Response | 54.7 Percentage of Participants |
Secondary
Area Under the Curve (AUC) of Calculated Glomerular Filtration Rate (cGFR) Between Baseline and Week 48
The improvement of AUC of cGFR was to be measured between Baseline and Week 48. This was to be analyzed with Analysis of Covariance (ANCOVA) with race and SOC as covariates.
Time frame: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48
Population: Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed.
Secondary
Average Corticosteroid Burden Measured by AUC of the Cumulative Corticosteroid Dose Between 16 and 48 Weeks
AUC is the area under the curve (mathematically known as definite integral) in a plot of concentration of drug in blood plasma against time. AUC was to be used to determine the average corticosteroid burden.
Time frame: Weeks 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed.
Secondary
Health Care Visits Over the 48-Week Treatment Period
The number of health care visits (including doctor's office visits, Emergency room/ Accident and Emergency \[ER/A&E\] visits and hospitalizations) over the 48-week treatment period were recorded.
Time frame: Weeks 1, 24, and 48
Population: Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed.
Secondary
Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit
CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. CD19+ cells were measured as cells per microliter (cells/uL).
Time frame: Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32
Population: N = number of participants analyzed at the specified visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Pre-infusion | 203.5 Cells/uL | Standard Deviation 191.4 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Pre-infusion | 125 Cells/uL | Standard Deviation 161.1 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Pre-infusion | 127.8 Cells/uL | Standard Deviation 190.1 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 | 262.7 Cells/uL | Standard Deviation 273.9 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 | 125.9 Cells/uL | Standard Deviation 186.9 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Post-infusion | 52.7 Cells/uL | Standard Deviation 72.6 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Baseline | 203.5 Cells/uL | Standard Deviation 191.4 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Post-infusion | 91.2 Cells/uL | Standard Deviation 109.2 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 4 | 209.7 Cells/uL | Standard Deviation 221.4 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Pre-infusion | 264.4 Cells/uL | Standard Deviation 276.6 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 | 116.6 Cells/uL | Standard Deviation 154.3 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 48 | 110 Cells/uL | Standard Deviation 114.3 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Post-infusion | 46.2 Cells/uL | Standard Deviation 54.4 |
| OCR 400 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Post-infusion | 103.1 Cells/uL | Standard Deviation 115.1 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Post-infusion | 11.1 Cells/uL | Standard Deviation 28.6 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Pre-infusion | 256.3 Cells/uL | Standard Deviation 300.2 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 48 | 11.7 Cells/uL | Standard Deviation 43.6 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Pre-infusion | 5.1 Cells/uL | Standard Deviation 16.5 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 | 1.9 Cells/uL | Standard Deviation 1.9 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Baseline | 256.3 Cells/uL | Standard Deviation 300.2 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Post-infusion | 1.2 Cells/uL | Standard Deviation 1.6 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 4 | 1.4 Cells/uL | Standard Deviation 2.5 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Post-infusion | 1 Cells/uL | Standard Deviation 1.5 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Pre-infusion | 2.5 Cells/uL | Standard Deviation 3.3 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Post-infusion | 1 Cells/uL | Standard Deviation 1.3 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 | 2.6 Cells/uL | Standard Deviation 3.6 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Pre-infusion | 1.9 Cells/uL | Standard Deviation 1.9 |
| OCR 1000 mg + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 | 7.8 Cells/uL | Standard Deviation 25.8 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 | 2 Cells/uL | Standard Deviation 3.8 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Baseline | 224.1 Cells/uL | Standard Deviation 231.7 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 | 2.2 Cells/uL | Standard Deviation 3.4 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 4 | 1.3 Cells/uL | Standard Deviation 1.6 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 | 2.1 Cells/uL | Standard Deviation 2.7 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 48 | 2.6 Cells/uL | Standard Deviation 8.9 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Pre-infusion | 222.8 Cells/uL | Standard Deviation 230.2 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Post-infusion | 5.7 Cells/uL | Standard Deviation 8.5 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Pre-infusion | 2.1 Cells/uL | Standard Deviation 3.3 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Post-infusion | 0.9 Cells/uL | Standard Deviation 1.4 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Pre-infusion | 2.1 Cells/uL | Standard Deviation 3.9 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Post-infusion | 0.8 Cells/uL | Standard Deviation 1 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Pre-infusion | 2 Cells/uL | Standard Deviation 2.7 |
| Placebo + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Post-infusion | 0.7 Cells/uL | Standard Deviation 1.4 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Baseline | 240.8 Cells/uL | Standard Deviation 268.9 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Post-infusion | 0.9 Cells/uL | Standard Deviation 1.3 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 48 | 7.3 Cells/uL | Standard Deviation 32.2 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Post-infusion | 0.9 Cells/uL | Standard Deviation 1.4 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Pre-infusion | 3.6 Cells/uL | Standard Deviation 11.8 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 4 | 1.4 Cells/uL | Standard Deviation 2.1 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Pre-infusion | 2.3 Cells/uL | Standard Deviation 3.6 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Pre-infusion | 240 Cells/uL | Standard Deviation 268 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Post-infusion | 8.4 Cells/uL | Standard Deviation 21.3 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Pre-infusion | 2 Cells/uL | Standard Deviation 2.7 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 | 5.1 Cells/uL | Standard Deviation 18.8 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 | 2 Cells/uL | Standard Deviation 2.7 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 | 2.3 Cells/uL | Standard Deviation 3.7 |
| OCR + SOC | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Post-infusion | 1 Cells/uL | Standard Deviation 1.3 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 | 141.2 Cells/uL | Standard Deviation 172.5 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Post-infusion | 102.4 Cells/uL | Standard Deviation 114.3 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 | 154.3 Cells/uL | Standard Deviation 222.2 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Baseline | 213.7 Cells/uL | Standard Deviation 201.7 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Pre-infusion | 322.5 Cells/uL | Standard Deviation 323.5 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Post-infusion | 106.3 Cells/uL | Standard Deviation 130.8 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 4 | 253.4 Cells/uL | Standard Deviation 263.9 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Pre-infusion | 156.5 Cells/uL | Standard Deviation 226.3 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 | 327.4 Cells/uL | Standard Deviation 324.9 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Post-infusion | 64.2 Cells/uL | Standard Deviation 83 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Post-infusion | 56.9 Cells/uL | Standard Deviation 62.5 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 48 | 134.9 Cells/uL | Standard Deviation 123.3 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Pre-infusion | 153.4 Cells/uL | Standard Deviation 180.6 |
| Placebo-Mycophenolate Mofetil (MMF) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Pre-infusion | 213.7 Cells/uL | Standard Deviation 201.7 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 | 68.5 Cells/uL | Standard Deviation 96.8 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Post-infusion | 30.9 Cells/uL | Standard Deviation 40.2 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Pre-infusion | 164.5 Cells/uL | Standard Deviation 118 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Baseline | 186.3 Cells/uL | Standard Deviation 175 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Pre-infusion | 186.3 Cells/uL | Standard Deviation 175 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 | 74.7 Cells/uL | Standard Deviation 75.3 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Pre-infusion | 72.2 Cells/uL | Standard Deviation 100.4 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 32 Post-infusion | 27.6 Cells/uL | Standard Deviation 29.5 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 48 | 61.3 Cells/uL | Standard Deviation 75 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 16 Pre-infusion | 76.3 Cells/uL | Standard Deviation 76.5 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 | 163.3 Cells/uL | Standard Deviation 115.8 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 1 Post-infusion | 104.3 Cells/uL | Standard Deviation 118.6 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Day 15 Post-infusion | 65.8 Cells/uL | Standard Deviation 50.4 |
| Placebo-Euro Lupus (EL) | Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Week 4 | 143.3 Cells/uL | Standard Deviation 107.4 |
Secondary
Percentage of Participants Achieving a Major Clinical Response or a Partial Clinical Response
A major clinical response was defined as British Isles Lupus Assessment Group (BILAG) C scores or better at Week 24 without developing any new A or two new B scores up to Week 24 and maintenance of this response without developing a moderate or severe flare between Week 24 and Week 48. A partial clinical response was defined as BILAG C scores or better at Week 24 and maintaining this response without developing a flare for 16 consecutive weeks. The BILAG is an organ-specific 86-question assessment based on the principle of the doctor's intent to treat, which requires an assessment of improved (1), the same (2), worse (3), or new (4) over the last month. Within each organ system, multiple manifestations and laboratory tests are combined into a single score for that organ. The resulting scores for each organ can be A through E, where A is very active disease, B is moderate activity, C is mild stable disease, D is resolved activity, and E indicates the organ was never involved.
Time frame: Baseline and Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: Efficacy date were summarized in the primary endpoints and due to early study termination the protocol was modified to transition the participants into the safety follow-up period. Additional efficacy outcome measures were not analyzed and study results focus on the full summary of safety data.
Secondary
Percentage of Participants Who Achieved a CRR or PRR And Who Received A Corticosteroid Dose of <10 Milligrams Per Day (mg/Day) From Week 24 to Week 48
CRR was defined as: 1. Normal serum creatinine (and with no more than a 25% increase from Baseline) 2. Inactive urinary sediment 3. Improvement in urinary protein:urinary creatinine ratio to ≤0.5. PRR was defined as at least 50% reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio was \>3, a urine protein:urine creatinine ratio of \<3 needed to be achieved.
Time frame: Week 48
Population: Efficacy date were summarized in the primary endpoints and due to early study termination the protocol was modified to transition the participants into the safety follow-up period. Additional efficacy outcome measures were not analyzed and study results focus on the full summary of safety data.
Secondary
Percentage of Participants Who Achieved a CRR or PRR And Who Received a Corticosteroid Dose of <5 mg/Day by Week 48
CRR was defined as: 1. Normal serum creatinine (and with no more than a 25% increase from Baseline) 2. Inactive urinary sediment 3. Improvement in urinary protein:urinary creatinine ratio to ≤0.5. PRR was defined as at least 50% reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio was \>3, a urine protein: urine creatinine ratio of \<3 needed to be achieved.
Time frame: Week 48
Population: Efficacy date were summarized in the primary endpoints and due to early study termination the protocol was modified to transition the participants into the safety follow-up period. Additional efficacy outcome measures were not analyzed and study results focus on the full summary of safety data.
Secondary
Percentage of Participants Who Achieved A Reduction In Systemic Lupus Erythematosis Disease Activity Index (SLEDAI) -2K Score
SLEDAI-2K measures disease activity at the visit or within the preceding 10 days. It comprised of 24 descriptors, covering 9 organ systems, and reflects disease activity over the previous 10 days.The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity
Time frame: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed.
Secondary
Percentage of Participants Who Achieved a Renal Response (Partial or Complete) by Week 36, and Sustain or Improve This Response Until Week 48
Time frame: Weeks 36, 40, 44, and 48
Population: Efficacy date were summarized in the primary endpoints and due to early study termination the protocol was modified to transition the participants into the safety follow-up period. Additional efficacy outcome measures were not analyzed and study results focus on the full summary of safety data.
Secondary
Percentage of Participants Who Achieved Clinically Meaningful Improvement in Fatigue Using the Functional Assessment of Chronic Illness Therapy (Facit) Fatigue Questionnaire From Baseline to Week 48
The FACIT Fatigue Scale is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued).
Time frame: Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed.
Secondary
Percentage of Participants Who Achieved Clinically Meaningful Improvement in Pain Using the Modified Brief Pain Inventory Short Form (mBPI-SF) From Baseline to Week 48
m-BPI-sf is a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours with a range of 0 (no pain) to 10 (worst imaginable pain).
Time frame: Baseline and Weeks 1, 12, 24, 36, and 48
Population: Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed.
Secondary
Percentage of Participants Who Achieved Clinically Meaningful Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF36) From Baseline to Week 48
The SF36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions physical role functioning, emotional role functioning, social role functioning, and mental health.
Time frame: Baseline and Weeks 1, 12, 24, 36, and 48
Population: Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed.
Secondary
Percentage of Participants Who Stopped Immunosuppressants After Week 48
The number of participants who stopped immunosuppressants were to be determined by survey.
Time frame: Week 48
Population: Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed.
Secondary
Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL)
CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. 0 represents 0% of participants.
Time frame: Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32
Population: N = number of participants analyzed at the specified visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Pre-infusion | 4.3 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Pre-infusion | 3.3 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Pre-infusion | 4.5 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 | 4.5 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 | 4.3 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Post-infusion | 11.5 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Baseline | 4.3 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Post-infusion | 7.5 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 4 | 4.4 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Pre-infusion | 4.4 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 | 7.4 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 48 | 5.9 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Post-infusion | 15 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Post-infusion | 10 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Post-infusion | 81.2 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Pre-infusion | 4.2 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 48 | 88.7 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Pre-infusion | 93.7 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Baseline | 4.2 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Post-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 4 | 98.5 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Post-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Pre-infusion | 97 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Post-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 | 95.8 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Pre-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 | 91.8 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 | 97.1 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Baseline | 1.5 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 | 97.1 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 4 | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 | 95.6 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 48 | 98.5 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Pre-infusion | 1.5 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Post-infusion | 83.8 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Pre-infusion | 97.1 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Post-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Pre-infusion | 97 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Post-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Pre-infusion | 95.2 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Post-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Baseline | 2.9 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Post-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 48 | 93.4 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Post-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Pre-infusion | 94.4 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 4 | 99.3 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Pre-infusion | 97 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Pre-infusion | 2.9 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Post-infusion | 82.5 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Pre-infusion | 98.6 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 | 93.6 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 | 98.6 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 | 96.5 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Post-infusion | 100 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 | 8.9 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Post-infusion | 14 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 | 6.7 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Baseline | 6.8 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Pre-infusion | 7 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Post-infusion | 11.9 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 4 | 7.3 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Pre-infusion | 7 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 | 7.5 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Post-infusion | 12.5 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Post-infusion | 10.5 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 48 | 4.4 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Pre-infusion | 5.1 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Pre-infusion | 6.8 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 | 4.3 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Post-infusion | 9.5 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Pre-infusion | 0 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Baseline | 0 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Pre-infusion | 0 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 | 0 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Pre-infusion | 0 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 32 Post-infusion | 22.7 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 48 | 8.7 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 16 Pre-infusion | 0 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 | 0 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 1 Post-infusion | 3.7 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Day 15 Post-infusion | 0 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <10 Cells Per Microliter (Cells/uL) | Week 4 | 0 Percentage of Participants |
Secondary
Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit
CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. n = number of participants analyzed at the specified visit. 0 represents 0% of participants.
Time frame: Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32
Population: N = number of participants analyzed at the specified visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Pre-infusion | 7.1 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Pre-infusion | 8.3 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Pre-infusion | 10.4 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 | 7.6 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 | 11.4 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Post-infusion | 41 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Baseline | 7.1 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Post-infusion | 17.9 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 4 | 10.3 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Pre-infusion | 7.4 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 | 13.2 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 48 | 17.6 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Post-infusion | 35 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Post-infusion | 22.9 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Post-infusion | 87 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Pre-infusion | 11.3 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 48 | 91.5 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Pre-infusion | 95.2 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Baseline | 11.3 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Post-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 4 | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Post-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Pre-infusion | 98.5 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Post-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 | 98.6 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Pre-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 | 93.2 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 | 98.6 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Baseline | 3 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 | 98.5 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 4 | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 48 | 98.5 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Pre-infusion | 3 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Post-infusion | 91.2 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Pre-infusion | 98.6 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Post-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Pre-infusion | 98.5 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Post-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Pre-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Post-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Baseline | 7.3 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Post-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 48 | 94.9 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Post-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Pre-infusion | 97.6 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 4 | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Pre-infusion | 98.5 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Pre-infusion | 7.2 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Post-infusion | 89.1 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Pre-infusion | 99.3 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 | 96.5 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 | 99.3 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 | 98.6 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Post-infusion | 100 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 | 15.6 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Post-infusion | 20.9 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 | 13.3 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Baseline | 11.4 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Pre-infusion | 9.3 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Post-infusion | 21.4 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 4 | 12.2 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Pre-infusion | 11.6 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 | 10 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Post-infusion | 32.5 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Post-infusion | 26.3 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 48 | 13.3 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Pre-infusion | 10.3 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Pre-infusion | 11.4 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 | 8.7 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Post-infusion | 57.1 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Pre-infusion | 4 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Baseline | 0 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Pre-infusion | 0 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 | 8 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Pre-infusion | 4.8 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 32 Post-infusion | 50 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 48 | 26.1 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 16 Pre-infusion | 8.3 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 | 3.8 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 1 Post-infusion | 25.9 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Day 15 Post-infusion | 12 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts <20 Cells/uL by Visit | Week 4 | 7.4 Percentage of Participants |
Secondary
Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit
CD19 is a cell surface molecule which assembles with the antigen receptor of B lymphocytes. It is a critical signal transduction molecule that regulates B lymphocyte development, activation, and differentiation. \<LLN = 80 cells/uL.
Time frame: Baseline, Day 15, Week 4, 16, 32, 48, and by infusion (pre and post infusion) on Day 1, 15, Week 16, 32
Population: N = number of participants analyzed at the specified visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Pre-infusion | 27.1 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Pre-infusion | 50 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Pre-infusion | 56.7 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 | 28.8 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 | 57.1 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Post-infusion | 80.3 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Baseline | 27.1 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Post-infusion | 58.2 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 4 | 39.7 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Pre-infusion | 30.0 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 | 52.9 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 48 | 51.5 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Post-infusion | 88.3 Percentage of Participants |
| OCR 400 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Post-infusion | 55.7 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Post-infusion | 97.1 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Pre-infusion | 36.6 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 48 | 97.2 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Pre-infusion | 98.4 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Baseline | 36.6 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Post-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 4 | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Post-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Pre-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Post-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Pre-infusion | 100 Percentage of Participants |
| OCR 1000 mg + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 | 97.3 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Baseline | 33.3 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 4 | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 48 | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Pre-infusion | 32.8 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Post-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Pre-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Post-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Pre-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Post-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Pre-infusion | 100 Percentage of Participants |
| Placebo + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Post-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Baseline | 35 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Post-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 48 | 98.5 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Post-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Pre-infusion | 99.2 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 4 | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Pre-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Pre-infusion | 34.8 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Post-infusion | 98.5 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Pre-infusion | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 | 98.6 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 | 100 Percentage of Participants |
| OCR + SOC | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Post-infusion | 100 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 | 35.6 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Post-infusion | .5 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 | 48.9 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Baseline | 29.5 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Pre-infusion | 32.6 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Post-infusion | 52.4 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 4 | 39 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Pre-infusion | 48.8 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 | 30 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Post-infusion | 72.5 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Post-infusion | 84.2 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 48 | 37.8 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Pre-infusion | 30.8 Percentage of Participants |
| Placebo-Mycophenolate Mofetil (MMF) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Pre-infusion | 29.5 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 | 87 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Post-infusion | 95.2 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Pre-infusion | 28 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Baseline | 23.1 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Pre-infusion | 23.1 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 | 72 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Pre-infusion | 85.7 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 32 Post-infusion | 95.5 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 48 | 78.3 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 16 Pre-infusion | 70.8 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 | 26.9 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 1 Post-infusion | 59.3 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Day 15 Post-infusion | 68 Percentage of Participants |
| Placebo-Euro Lupus (EL) | Percentage of Participants With CD19+ Absolute B Cell Counts Less Than the Lower Limit of Normal (LLN) by Visit | Week 4 | 40.7 Percentage of Participants |
Secondary
Time To Complete Renal Response
Time to complete renal response was proposed to be analyzed using a stratified log rank test with race and SOC as stratification factors. Comparisons of ocrelizumab versus placebo were to be expressed as p-values, estimated hazard ratios, adjusted proportions of participants who achieved a complete renal response and their 95% confidence intervals. Kaplan-Meier curves were to be produced. Due to early termination of the study the analyses were not performed.
Time frame: Baseline up to Week 48
Population: Efficacy date were summarized in the primary endpoints and due to early study termination the protocol was modified to transition the participants into the safety follow-up period. Additional efficacy outcome measures were not analyzed and study results focus on the full summary of safety data.
Secondary
Time to First Renal Flare In Those Participants Who Demonstrated at Least a Partial Renal Response
Renal flares may be either proteinuric or nephritic as defined below: Proteinuric Flares are defined as follows:In participants who achieve a urine protein:urine creatinine (Upr:Ucr) ≤ 0.5, an increase to Upr:Ucr \>1; In participants with an Upr:Ucr \>0.5, a doubling of Upr:Ucr (with a minimum increase to Upr:Ucr \>2). Nephritic Flare defined as: Increase in serum creatinine of ≥30% from the lowest value achieved in the study accompanied by Increase Upr:Ucr \>1 Or New/worsening active urine sediment on two consecutive occasions, in the absence of urinary tract infection or other causes of hematuria.
Time frame: Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
Population: Efficacy date were summarized in the primary endpoints and due to early study termination the protocol was modified to transition the participants into the safety follow-up period. Additional efficacy outcome measures were not analyzed and study results focus on the full summary of safety data.