Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus

Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169

SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale \[VAS\]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores. An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c). An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)

Time frame: At Day 169

Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85

SRI is the Systemic Lupus Erythematosus Responder Index. An SRI(4) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 4 points AND (a)no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale \[VAS\]) compared to Baseline) AND (b) no new BILAG-2004 Index A organ system score AND (c)no more than one new or worsening BILAG-2004 Index B organ system scores. An SRI(5) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 5 points AND (a) AND (b) AND (c). An SRI(6) Response is defined as a reduction in Day 1 SLEDAI-2K disease activity score of ≥ 6 points AND (a) AND (b) AND (c) The outcomes are better in increasing order from SRI(4) to SRI(5) to SRI(6)

Time frame: At Day 85

Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85

BICLA is defined as: British Isle Lupus Assessment Group improvement, defined as BILAG As at Baseline improved to B/C/D, and BILAG Bs at baseline improved to C/D, and no BILAG worsening in other BILAG organ systems such that there are no new BILAG As or greater than 1 new BILAG B; and no worsening in the SLEDAI-2K total score compared to Baseline (defined as no increase in SLEDAI total score); and no worsening in the physician's global assessment (MDGA) of disease activity ("no worsening" is defined as less than 10% worsening, equivalent to a 10mm increase on a 100mm visual analog scale \[VAS\]) compared to Baseline; No changes in concomitant medications according to the following criteria: No increase of or addition of a new immunosuppressant agent (azathioprine,mycophenolic acid/mycophenolate mofetil, methotrexate, anti-malarial, leflunomide) over baseline levels; No increase in corticosteroid dose above baseline level outside of those allowed per protocol.

Time frame: At Day 85

Mean Change From Baseline in CLASI Score at Day 85 and Day 169

Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.

Time frame: At Day 85 and Day 169

Percentage of Participants With an Improvement of >4 or a Decrease of >50% From Baseline in Their Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Score

Mean change from baseline, CLASI = Cutaneous Lupus Erythematosus Disease Area and Severity Index. Scores can range from 0 to 70 with higher scores denoting greater disease activity or damage.

Time frame: At Day 85 and Day 169

Change From Baseline in Arthritis, as Assessed by American College of Rheumatology (ACR) 28-joint Count of Tender and Swollen Joints on Day 85 and Day 169

Mean Change from Baseline Over Time; Measured by Disease Activity Score 28: A single score on a continuous scale (0-9.4). The level of RA disease activity can be interpreted as low (DAS28 \<=3.2),moderate (3.2 \< DAS28 \<=5.1), or as high disease activity (DAS28 \> 5.1)

Time frame: At baseline, Day 85 and Day 169

Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169

Overall British Isles Lupus Assessment Group-2004 score, BILAG Scores: A=Severe disease activity, B=Moderate disease activity, C=Mild disease, D=Inactive disease but previously affected, E=System never involved.The categories are converted to a numeric score (A=9, B=3, C=1, D=0, E=0) and treated as a continuous variable. Higher score= more severe disease activity.

Time frame: At baseline, Day 85 and Day 169

Cumulative Corticosteroid and Immunosuppressant Use

Percent of participants requiring use of corticosteroids and mmunosuppressants use over time

Time frame: Up to one day prior to the first dose of long-term extension period or up to 42 days post last short-term dose date, which ever is earlier

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest

Although there are no identified risks for BMS-931699, BMS has developed a list of events of special interest for the BMS-931699 program based on the known biologic class effects, the mechanism of action of BMS-931699, overall potential consequences of mmunosuppression, and preliminary data from unblinded clinical trials. Event categories of special interest for this study may include, but are not limited to: Infections, Autoimmunity, Malignancies, Injection-related reactions

Time frame: On or after the first dose date of short-term study medication and up to 42 days post last short-term dose date or up to the day prior to the first dose of long-term extension period, whichever is earlier

Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate

HEART RATE (HR) Beats per min (BPM): HR \> 100 AND CHANGE FROM BASELINE \> 30 OR HR \< 55 AND CHANGE FROM BASELINE \< -15

Time frame: At Day 85 and Day 169

Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure

SYSTOLIC BLOOD PRESSURE (SYSBP) (MMHG); SYSBP \> 140 AND CHANGE FROM BASELINE \> 20 OR SYSBP \< 90 AND CHANGE FROM BASELINE \< -20; DIASTOLIC BLOOD PRESSURE (DIABP) \> 90 AND CHANGE FROM BASELINE \> 10 OR DIABP \< 55 AND CHANGE FROM BASELINE \< -10;

Time frame: At Day 85 and Day 169

Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate

RESPIRATION RATE (RESP) (PER MIN) RESP \> 16 OR RESP CHANGE FROM BASELINE \> 10

Time frame: At Day 85 and Day 169

Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature

TEMPERATURE (TEMP) (C) TEMP \> 38.3 OR TEMP CHANGE FROM BASELINE \> 1.6

Time frame: At Day 85 and Day 169

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

QTc (corrected QT) Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF

Time frame: Up to 42 days post last dose of short-term double-blind study medication or up to the day prior to the start of long-term extension period, whichever is earlier.

Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified

Pharmacokinetics of BMS-931699 derived from serum concentration versus time data; Ctrough = Trough level serum concentration of BMS-931699 at time point specified Pharmacokinetic Population: defined as all subjects who receive any study medication and have any available concentration-time data.

Time frame: Day 169

Serum Biomarkers C3, C4

Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169

Time frame: At Day 85 and Day 169

Serum Biomarkers: Anti-Nuclear Antibodies (ANA)

Serum biomarkers C3, C4, anti-double-stranded deoxyribonucleic acid (anti-dsDNA), anti-nuclear antibody (ANA) and other autoantibodies were measured from blood serum samples collected on Day 85 and Day 169. No anti-dsDNA data was available for this report

Time frame: At Day 85 and Day 169

Short Term: Receptor Occupancy Over Time

Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy

Time frame: At Day 85 and Day 169

Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified

Immunogenicity defined as positive for anti-drug antibodies post-baseline measurement if baseline missing or negative. If baseline is positive, then immunogenicity is defined as a positive post-baseline measurement with titer value 4 times greater than baseline. (A) all subjects with a laboratory reported positive antibody responses to BMS-931699 during the short-term double-blind treatment period are included. Overall: At least one positive sample relative to baseline during short-term double-blind and follow-up period.

Time frame: Day 169

Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I

HEMATOLOGY I: ERYTHROCYTE/PLATELET ATTRIBUTES HEMOGLOBIN G/L L \< 0.85×PRE-RX; HEMATOCRIT VOL L \< 0.85×PRE-RX; PLATELET COUNT X10\*9 C/L H \> 1.5×ULN (ULN = Upper Limit of Normal) IF PRE-RX IS MISSING OR \> 1.5×ULN PLATELET COUNT X10\*9 C/L L \< 0.85×LLN (LLN = Lower Limit of Normal) IF PRE-RX IS MISSING OR \< 0.85×LLN IF PRE-RX \>= LLN OR \< 0.85×PRE-RX IF PRE-RX \< LLN; ERYTHROCYTES RBC X10\*12 C/L L \< 0.85×PRE-RX HEMATOLOGY II QUANTITATIVE WBC : LEUKOCYTES X10\*9 C/L H \> 1.2×ULN IF PRE-RX IS MISSING OR \> 1.2×ULN IF LLN \<= PRE-RX \<= ULN OR \> 1.5×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN; LEUKOCYTES WBC X10\*9 C/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF LLN \<= PRE-RX \<= ULN OR \< 0.85×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II

WBC DIFFERENTIAL COUNT: BASOPHILS (ABSOLUTE) X10\*9 C/L H \> 0.4; BLASTS (ABSOLUTE) X10\*9 C/L H \> 0; EOSINOPHILS (ABSOLUTE) EOSA X10\*9 C/L H \> 0.75; LYMPHOCYTES (ABSOLUTE) X10\*9 C/L H \> 7.5; LYMPHOCYTES (ABSOLUTE) X10\*9 C/L L \< 0.75; MONOCYTES (ABSOLUTE) X10\*9 C/L H \> 2; NEUTROPHILS (ABSOLUTE) X10\*9 C/L L \< 1.5 IF PRE-RX IS MISSING OR \< 1.5 IF PRE-RX \>= 1.5 OR \< 0.85×PRE-RX IF PRE-RX \< 1.5; COAGULATION activated Partial thromboplastin time (APTT) SEC H \> 1.5×ULN; INTL NORMALIZED RATIO (INR) INR FRACTION H \> 1.5×ULN PROTHROMBIN TIME (PT) PT SEC H \> 1.5×ULN

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS

LIVER FUNCTION TESTS:ALKALINE PHOSPHATASE (ALP) ALP U/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN; BILIRUBIN, DIRECT UMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN G-GLUTAMYL TRANSFERASE (GGT) GGT U/L H \> 1.15×ULN IF PRE-RX IS MISSING OR \> 1.15×ULN IF PRE-RX \<= ULN OR \> 1.2×PRE-RX IF PRE-RX \> ULN BILIRUBIN, TOTAL UMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS

KIDNEY FUNCTION TESTS:BLOOD UREA NITROGEN MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.2×PRE-RX IF PRE-RX \> ULN CREATININE UMOL/L H \> 1.5×ULN IF PRE-RX IS MISSING OR \> 1.5×ULN IF PRE-RX \<= ULN OR \> 1.33×PRE-RX IF PRE-RX \> ULN GLOMERULAR FILTRATION RATE, CALC. ML/S/M\*2 L \< 0.8×PRE-RX; UREA UREA MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.2×PRE-RX IF PRE-RX \> ULN

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1

CALCIUM, TOTAL MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.1×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN; CALCIUM, TOTAL MMOL/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN; CHLORIDE, SERUM MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.1×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN; CHLORIDE, SERUM MMOL/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN;

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2

BICARBONATE MMOL/L H \> 1.2×ULN IF PRE-RX IS MISSING OR \> 1.2×ULN IF PRE-RX \<= ULN OR \> 1.2×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN; BICARBONATE MMOL/L L \< 0.8×LLN IF PRE-RX IS MISSING OR \< 0.8×LLN IF PRE-RX \>= LLN OR \< 0.8×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN; POTASSIUM, SERUM MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.1×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN; POTASSIUM, SERUM MMOL/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN; MAGNESIUM, SERUM MMOL/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.1×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN MAGNESIUM, SERUM MMOL/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3

SODIUM, SERUM MMOL/L H \> 1.05×ULN IF PRE-RX IS MISSING OR \> 1.05×ULN IF PRE-RX \<= ULN OR \> 1.05×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN SODIUM, SERUM MMOL/L L \< 0.95×LLN IF PRE-RX IS MISSING OR \< 0.95×LLN IF PRE-RX \>= LLN OR \< 0.95×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN PHOSPHORUS, INORGANIC PHOS MMOL/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN PHOSPHORUS, INORGANIC PHOS MMOL/L L \< 0.85×LLN IF PRE-RX IS MISSING OR \< 0.85×LLN IF PRE-RX \>=LLN OR \< 0.85×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1

GLUCOSE TESTS:GLUCOSE, FASTING SERUM MMOL/L H \> 1.3×ULN IF PRE-RX IS MISSING OR \> 1.3×ULN IF PRE-RX \<= ULN OR \> 2×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN GLUCOSE, FASTING SERUM MMOL/L L \< 0.8×LLN IF PRE-RX IS MISSING OR \< 0.8×LLN IF PRE-RX \>= LLN OR \< 0.8×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN; PROTEIN TESTS:ALBUMIN G/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN PROTEIN, TOTAL G/L H \> 1.1×ULN IF PRE-RX IS MISSING OR \> 1.1×ULN IF PRE-RX \<= ULN OR \> 1.1×PRE-RX IF PRE-RX \> ULN OR \> ULN IF PRE-RX \< LLN PROTEIN, TOTAL G/L L \< 0.9×LLN IF PRE-RX IS MISSING OR \< 0.9×LLN IF PRE-RX \>= LLN OR \< 0.9×PRE-RX IF PRE-RX \< LLN OR \< LLN IF PRE-RX \> ULN

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2

OTHER CHEMISTRY TESTING LIPID TESTS: CHOLESTEROL, TOTAL (TC) MMOL/L H \> 1.2×ULN IF PRE-RX IS MISSING OR \> 1.2×ULN IF PRE-RX \<= ULN OR \> 1.2×PRE-RX IF PRE-RX \> ULN TRIGLYCERIDES, FASTING MMOL/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.5×PRE-RX IF PRE-RX \> ULN PANCREATIC TESTS: AMYLASE, TOTAL U/L H \> 1.5×ULN; LIPASE, TOTAL (TURBIDIMETRIC ASSAY) U/L H \> 1.5×ULN; LIPASE, TOTAL (COLORIMETRIC ASSAY) U/L H \> 1.5×ULN; ENDOCRINE TESTS:CORTISOL, AM NMOL/L L \< 138 THYROID STIMULATING HORMONE (TSH) TSH MU/L H \> 1.5×ULN IF PRE-RX IS MISSING OR \> 1.5×ULN IF PRE-RX \<= ULN OR \> 2×PRE-RX IF PRE-RX \> ULN

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3

OTHER CHEMISTRY TESTING CARDIAC TESTS: CREATINE KINASE (CK) CK U/L H \> 1.5×ULN IF PRE-RX IS MISSING OR \> 1.5×ULN IF PRE-RX \<= ULN OR \> 1.5×PRE-RX IF PRE-RX \> ULN; TROPONIN-I, CARDIAC SPECIFIC UG/L H \> ULN; METABOLITE TESTS:URIC ACID URIC MMOL/L H \> 1.2×ULN IF PRE-RX IS MISSING OR \> 1.2×ULN IF PRE-RX \<= ULN OR \> 1.25×PRE-RX IF PRE-RX \> ULN; CHEM TEST, MULTI INDICATIONS : LACTATE DEHYDROGENASE (LD) LD U/L H \> 1.25×ULN IF PRE-RX IS MISSING OR \> 1.25×ULN IF PRE-RX \<= ULN OR \> 1.5×PRE-RX IF PRE-RX \> ULN

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY

IMMUNE ACTIVATION MARKERS:C-REACTIVE PROTEIN (CRP) CRP MG/L H \> 1.5×ULN; CRP, HIGH SENSITIVITY MG/L H \> 1.5×ULN;

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS

QUALITATIVE URINE CHEMISTRY: BLOOD, URINE N/A H \>= 2 IF PRE-RX IS MISSING OR \>= 2 IF PRE-RX \< 1 OR \>= 2×PRE-RX IF PRE-RX \>= 1 GLUCOSE, URINE N/A H \>= 1 IF PRE-RX IS MISSING OR \>= 1 IF PRE-RX \< 1 OR \>= 2×PRE-RX IF PRE-RX \>= 1 PROTEIN, URINE UNKNOWN H \>= 2 IF PRE-RX IS MISSING OR \>= 2 IF PRE-RX \< 1 OR \>= 2×PRE-RX IF PRE-RX \>= 1 URINALYSIS II URINE WBC + RBC ; RBC, URINE HPF H \>= 2 IF PRE-RX IS MISSING OR \>= 2 IF PRE-RX \< 2 OR \>= 4 IF PRE-RX \>= 2 WBC, URINE HPF H \>= 2 IF PRE-RX IS MISSING OR \>= 2 IF PRE-RX \< 2 OR \>= 4 IF PRE-RX \>= 2

Time frame: Up to 42 days post last dose of study medication in short-term or long-term extension period

Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169

Systemic Lupus Erythematosus Disease Activity Index, SLEDAI; Version 2000, also known as SLEDAI-2K. The SLEDAI-2K score is a weighted, cumulative index of lupus disease activity. SLEDAI-2K is calculated from 24 individual descriptors across 9 organ systems; 0 indicates inactive disease and the maximum theoretical score is 105.

Time frame: At baseline, Day 85 and Day 169

Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169

Physician Global Assessment of Arthritis was measured by asking the physician to assess the participant's current arthritis disease activity by placing a vertical line on a 0 to 100 millimeter (mm) visual analog scale (VAS), where 0 mm = very good and 100 mm = very bad.

Time frame: At baseline, Day 85 and Day 169