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

简要总结

详细描述

主要结局

次要结局

• Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169(At baseline, Day 85 and Day 169)
• Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified(Day 169)
• Serum Biomarkers C3, C4(At Day 85 and Day 169)
• Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169(At Day 169)
• Mean Change From Baseline in CLASI Score at Day 85 and Day 169(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(At Day 85 and Day 169)
• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest(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 BICLA Response (BICLA Response Rate) at Day 85(At Day 85)
• Cumulative Corticosteroid and Immunosuppressant Use(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)
• Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85(At Day 85)
• 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(At baseline, Day 85 and Day 169)
• Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate(At Day 85 and Day 169)
• Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure(At Day 85 and Day 169)
• Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate(At Day 85 and Day 169)
• Serum Biomarkers: Anti-Nuclear Antibodies (ANA)(At Day 85 and Day 169)
• Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2(Up to 42 days post last dose of study medication in short-term or long-term extension period)
• Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature(At Day 85 and Day 169)
• Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(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.)
• Short Term: Receptor Occupancy Over Time(At Day 85 and Day 169)
• Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified(Day 169)
• Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1(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 I(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(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(At baseline, Day 85 and Day 169)
• Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169(At baseline, Day 85 and Day 169)
• Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II(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(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(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(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(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(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(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(Up to 42 days post last dose of study medication in short-term or long-term extension period)