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

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

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.

Study Overview

• Status: Completed
• Conditions: Lupus
• Intervention / Treatment: Drug: BMS-931699; Drug: Placebo matching BMS-931699

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)

• Study Type: Interventional
• Enrollment (Actual): 730
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental:Arm A: BMS-931699; 12.5mg subcutaneous (SC) injection Weekly dosing	Drug: BMS-931699; Other Names: lulizumab pegol
Experimental: Experimental:Arm B: BMS-931699; 12.5mg SC injection Every other Week dosing	Drug: BMS-931699; Other Names: lulizumab pegol
Experimental: Experimental:Arm C: BMS-931699; 5mg SC injection Every other Week dosing	Drug: BMS-931699; Other Names: lulizumab pegol
Experimental: Experimental:Arm D: BMS-931699; 1.25mg SC injection Every other Week dosing	Drug: BMS-931699; Other Names: lulizumab pegol
Placebo Comparator: Placebo Comparator: Arm E: Placebo matching BMS-931699; 0mg SC injection Weekly dosing	Drug: Placebo matching BMS-931699

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) 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.	At Day 169

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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.	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.	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.	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)	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.	At baseline, Day 85 and Day 169
Cumulative Corticosteroid and Immunosuppressant Use	Percent of participants requiring use of corticosteroids and mmunosuppressants use over time	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	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	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;	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	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	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	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.	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	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	At Day 85 and Day 169
Short Term: Receptor Occupancy Over Time	Percent CD4+ Receptor Occupancy and percent CD8+ Receptor Occupancy	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.	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	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	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	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	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;	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	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	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	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	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	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;	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	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.	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.	At baseline, Day 85 and Day 169

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.

Helpful Links

• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2014
• Primary Completion (Actual): October 26, 2017
• Study Completion (Actual): November 30, 2017

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Actual): October 7, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: IM128-027; 2014-002184-14 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No