Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02265744
Recruitment Status : Completed
First Posted : October 16, 2014
Results First Posted : January 4, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.

Condition or disease Intervention/treatment Phase
Lupus Drug: BMS-931699 Drug: Placebo matching BMS-931699 Phase 2

Detailed Description:
  1. Subjects completing Day 169 (24 weeks) on study medication may be eligible to enter an optional LTE period
  2. The LTE period will remain blinded but will no longer have a placebo arm:

    • Subjects will remain on their originally assigned treatment arm unless they were on placebo
    • Subjects initially randomized to placebo arm will be automatically re-randomized into one of the existing active arms at Day 169 (24 weeks)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 730 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Lulizumab Pegol vs. Placebo on a Background of Limited Standard of Care in the Treatment of Subjects With Active Systemic Lupus Erythematosus
Actual Study Start Date : November 13, 2014
Actual Primary Completion Date : October 26, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Experimental:Arm A: BMS-931699
12.5mg subcutaneous (SC) injection Weekly dosing
Drug: BMS-931699
Other Name: lulizumab pegol

Experimental: Experimental:Arm B: BMS-931699
12.5mg SC injection Every other Week dosing
Drug: BMS-931699
Other Name: lulizumab pegol

Experimental: Experimental:Arm C: BMS-931699
5mg SC injection Every other Week dosing
Drug: BMS-931699
Other Name: lulizumab pegol

Experimental: Experimental:Arm D: BMS-931699
1.25mg SC injection Every other Week dosing
Drug: BMS-931699
Other Name: lulizumab pegol

Placebo Comparator: Placebo Comparator: Arm E: Placebo matching BMS-931699
0mg SC injection Weekly dosing
Drug: Placebo matching BMS-931699



Primary Outcome Measures :
  1. Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169 [ Time Frame: At Day 169 ]
    The British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) is a measure of systemic lupus erythematosus (SLE) response. 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.


Secondary Outcome Measures :
  1. Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169 [ Time Frame: 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)


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


  3. Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85 [ Time Frame: 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.

  4. Mean Change From Baseline in CLASI Score at Day 85 and Day 169 [ Time Frame: 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.

  5. 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 [ Time Frame: 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.

  6. 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 [ Time Frame: At baseline, 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)

  7. Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169 [ Time Frame: At baseline, 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.

  8. Cumulative Corticosteroid and Immunosuppressant Use [ 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 ]
    Percent of participants requiring use of corticosteroids and mmunosuppressants use over time

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

  10. Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate [ Time Frame: At Day 85 and Day 169 ]
    HEART RATE (HR) Beats per min (BPM): HR > 100 AND CHANGE FROM BASELINE > 30 OR HR < 55 AND CHANGE FROM BASELINE < -15

  11. Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure [ Time Frame: At Day 85 and Day 169 ]
    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;

  12. Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate [ Time Frame: At Day 85 and Day 169 ]
    RESPIRATION RATE (RESP) (PER MIN) RESP > 16 OR RESP CHANGE FROM BASELINE > 10

  13. Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature [ Time Frame: At Day 85 and Day 169 ]
    TEMPERATURE (TEMP) (C) TEMP > 38.3 OR TEMP CHANGE FROM BASELINE > 1.6

  14. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities [ 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. ]
    QTc (corrected QT) Fridericia, PR Interval, QRS Interval and Change from baseline in QTCF

  15. Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified [ Time Frame: Day 169 ]
    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.

  16. Serum Biomarkers C3, C4 [ Time Frame: At Day 85 and Day 169 ]
    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

  17. Serum Biomarkers: Anti-Nuclear Antibodies (ANA) [ Time Frame: At Day 85 and Day 169 ]
    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

  18. Short Term: Receptor Occupancy Over Time [ Time Frame: At Day 85 and Day 169 ]
    Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy

  19. Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified [ Time Frame: Day 169 ]
    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.

  20. Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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

  21. Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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

  22. Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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

  23. Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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

  24. Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1 [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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;

  25. Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2 [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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

  26. Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3 [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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

  27. Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1 [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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

  28. Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2 [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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

  29. Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3 [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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

  30. Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    IMMUNE ACTIVATION MARKERS:C-REACTIVE PROTEIN (CRP) CRP MG/L H > 1.5×ULN; CRP, HIGH SENSITIVITY MG/L H > 1.5×ULN;

  31. Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS [ Time Frame: Up to 42 days post last dose of study medication in short-term or long-term extension period ]
    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

  32. Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169 [ Time Frame: At baseline, 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.

  33. Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169 [ Time Frame: At baseline, 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Male or female aged between 18 to 70 (included)
  • Diagnosed with active systemic lupus erythematosus by a doctor
  • Disease must be in patient's joints or on the skin at a minimum
  • Taking other medications is allowed but some are excluded

Exclusion Criteria:

  • Diagnosed with active lupus nephritis, multiple sclerosis or rheumatoid arthritis
  • Diagnosed with active tuberculosis or an ongoing infection with a bacteria or a virus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265744


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama, United States, 35801
United States, California
St Jude Hospital Yorba Linda
Fullerton, California, United States, 92835
Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
Long Beach, California, United States, 90806
Harbor UCLA Medical Center
Torrance, California, United States, 90509
United States, Connecticut
University Of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Local Institution
Trumbull, Connecticut, United States, 06611
United States, Florida
Center For Rheumatology, Immunology And Arthritis
Fort Lauderdale, Florida, United States, 33309
The Arthritis Center
Palm Harbor, Florida, United States, 34684-3176
United States, Georgia
Jefrey D. Lieberman, Md., Pc
Decatur, Georgia, United States, 30033
United States, Idaho
Coeur D'Alene Arthrit Clin
Coeur d'Alene, Idaho, United States, 83814-2644
United States, Kansas
Heartland Research Associates, Llc
Wichita, Kansas, United States, 67207-5150
United States, Massachusetts
Beth Israel Deaconess Med. Center Div. Of Gastroenterology
Boston, Massachusetts, United States, 02215
United States, Nebraska
Physician Research Collaboration, Llc
Lincoln, Nebraska, United States, 68516
United States, New Mexico
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States, 87102-2631
United States, New York
North Shore Lij Health System
Great Neck, New York, United States, 11021
The Feinstein Institute For Medical Research
Manhasset, New York, United States, 11030
United States, North Carolina
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Joint and Muscle Medical Care and Research Institute (JMMCRI)
Charlotte, North Carolina, United States, 28204
Pmg Research Of Salisbury
Salisbury, North Carolina, United States, 28144
United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, United States, 18015
Allegheny-Singer Research Institute (Asri)
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Tekton Research Inc
Austin, Texas, United States, 78745
Local Institution
Dallas, Texas, United States, 75246
United States, Washington
Arthritis Northwest
Spokane, Washington, United States, 99204
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, 1431
Hospital General De Agudos J.M. Ramos Mejia
Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1221
Instituto De Investigaciones Clinicas De Mar Del Plata
Mar Del Plata, Buenos Aires, Argentina, 7600
Instituto de Asistencia Reumatologica Integral
San Fernando, Buenos Aires, Argentina, 1646
Clinica De Reumatologia
Rosario, Santa FE, Argentina, 2000
Centro Consultora Integral de Salud SRL
Cordoba, Argentina, 5004
Brazil
Servicos Especializados em Reumatologia SER
Savaldor, Bahia, Brazil, 40150-150
Cip Pesquisas Medicas
Goiania, Goias, Brazil, 74110-120
Centro Mineiro De Pesquisa
Juiz de Fora, Minas Gerais, Brazil, 36010570
Centro Medico Varginha
Varginha, Minas Gerais, Brazil, 37006-710
Edumed - Educacao em Saude S/S LTDA
Curitiba, Parana, Brazil, 80440-210
LMK Servicos Medicos S S Ltda
Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
CPCLIN Centro de Pesquisas Clinicas LTDA
Sao Paulo, Brazil, 01244-030
Lar Escola AACD
Sao Paulo, Brazil, 04032-060
Canada, Newfoundland and Labrador
Karma Clinical Trials Inc.
St. John's, Newfoundland and Labrador, Canada, A1A 4Y3
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4K1
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada, M5T 2S8
Canada, Quebec
Centre De Recherche Musculo-Squelettique
Trois-rivieres, Quebec, Canada, G8Z 1Y2
Canada
CHU de Quebec Research Centre
Quebec, Canada, G1V 4G2
Chile
Centro De Estudios Reumatologicos
Santiago De Chile, Metropolitana, Chile, 7501126
Hospital San Borja Arriaran
Santiago, Region Metropolitana, Chile, 8360156
Colombia
Riesgo De Fractura
Bogota, Cundinamarca, Colombia
Servimed E.U
Bucaramanga, Santander, Colombia
Clinica De La Costa
Barranquilla, Colombia
Hospital Pablo Tobon Uribe
Medellin, Colombia, MEDELLIN
France
Local Institution
Bordeaux Cedex, France, 33076
Local Institution
Lille Cedex, France, 59037
Local Institution
Marseille, France, 13003
Local Institution
Paris Cedex 13, France, 75651
Local Institution
Strasbourg, France, 67098
Germany
Campus Charite Mitte
Berlin, Germany, 10117
Medizinsche Universitaetsklinik Freiburg
Freiburg, Germany, 79106
Universitaetshautklinik Heidelberg
Heidelberg, Germany, 69120
Johannes Gutenberg - Universitaet
Mainz, Germany, 55131
Hungary
Budai Irgalmasrendi Korhaz
Budapest, Hungary, 1027
Infektologiai-Hepatologiai Osztaly
Gyula, Hungary, 5700
Borgyogyaszati Klinika
Szeged, Hungary, 6720
Italy
Arcispedale S. Anna
Cona - Ferrara, Italy, 44124
Azienda Ospedaliera Luigi Sacco
Milano, Italy, 20154
Azienda Ospedaliera Di Padova
Padova, Italy, 35128
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy, 56126
Policlinico Umberto I
Roma, Italy, 00185
Japan
Local Institution
Chiba-shi, Chiba, Japan, 2608677
Local Institution
Fukuoka-shi, Fukuoka, Japan, 8128582
Local Institution
Kitakyushu-shi, Fukuoka, Japan, 8078555
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608604
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Kanazawa-shi, Ishikawa, Japan, 9208641
Local Institution
Sendai, Miyagi, Japan, 9808574
Local Institution
Sasebo-shi, Nagasaki, Japan, 8571195
Local Institution
Shimotsuke-shi, Tochigi, Japan, 3290498
Local Institution
Bunkyo-ku, Tokyo, Japan, 1138655
Local Institution
Chuo-ku, Tokyo, Japan, 1048560
Local Institution
Fuchu, Tokyo, Japan, 1838524
Local Institution
Itabashi-ku, Tokyo, Japan, 1738610
Local Institution
Meguro-ku, Tokyo, Japan, 1538515
Local Institution
Shinjuku-Ku, Tokyo, Japan, 1608582
Korea, Republic of
Local Institution
Daejeon, Korea, Republic of, 35015
Local Institution
Incheon, Korea, Republic of, 22332
Local Institution
Seoul, Korea, Republic of, 04763
Local Institution
Seoul, Korea, Republic of, 07345
Lebanon
Local Institution
Beirut, Lebanon
Local Institution
Tripoli, Lebanon
Mexico
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
Mexico City, Distrito Fededral, Mexico, 11850
Instituto para el DeSarrollo Integral de la Salud S de RL de CV
Mexico, Distrito Federal, Mexico, 06700
Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia
León, Guanajuato, Mexico, 37000
Centro Integral En Reumatologia Sa De Cv
Guadalajara, Jalisco, Jalisco, Mexico, 44160
Clinica de Investigacion en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, Mexico, 44650
Centro de Radiodiagnostico Computarizado Medico de Tabasco S.A. de C.V.
Villahermosa, Tabasco, Mexico, 86190
Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.
Distrito Federal, Mexico, 14080
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
San Luis Potosi, Mexico, 78213
Unidad Reumatologica Las Americas, S.C. P.
Yucatan, Mexico, 97000
Netherlands
Local Institution
Den Haag, Netherlands, 2545 CH
Local Institution
Groningen, Netherlands, 9700 RB
Peru
Clinica Anglo Americana
Lima, Peru, 27
Hospital Nacional Cayetano Heredia
Lima, Peru, LIMA 31
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
Lima, Peru, LIMA 33
Poland
Local Institution
Lublin, Poland, 20-954
Medyczne Centrum Hetmanska Indywidualna Spec. Praktyka Lekar
Poznan, Poland, 60-218
Local Institution
Warszawa, Poland, 00-465
Puerto Rico
Local Institution
San Juan, Puerto Rico, 00918
Romania
Sf. Maria Clinical Hospital,Bucharest
Bucharest, Romania, 011192
Spitalul Clinic de Recuperare Iasi
Iasi, Romania, 700661
Russian Federation
Local Institution
St Petersburg, Russian Federation, 191124
Local Institution
Tolyatti, Russian Federation, 445039
South Africa
Local Institution
Johannesburg, Gauteng, South Africa
Local Institution
Soweto, Gauteng, South Africa, 2013
Local Institution
Cape Town, Western CAPE, South Africa, 7500
Local Institution
Stellenbosch, Western CAPE, South Africa, 7600
Spain
Hosp Univer 12 De Octubre
Madrid, Spain, 28041
Hospital Carlos Haya De Malaga
Malaga, Spain, 29010
Hospital Meixoeiro
Vigo, Spain, 36241
Taiwan
Local Institution
Kaohsiung, Taiwan, 833
Local Institution
Taichung, Taiwan, 40447
Local Institution
Taipei, Taiwan, 100
Local Institution
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] May 3, 2015
Statistical Analysis Plan  [PDF] June 28, 2016


Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02265744     History of Changes
Other Study ID Numbers: IM128-027
2014-002184-14 ( EudraCT Number )
First Posted: October 16, 2014    Key Record Dates
Results First Posted: January 4, 2019
Last Update Posted: October 7, 2019
Last Verified: October 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs