Clinical trial NCT02265744: Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-10-16
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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)

Eligibility 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

Primary outcomes:
measure: Percentage of Participants Who Achieve a BICLA Response (BICLA Response Rate) at Day 169
timeFrame: At Day 169
Secondary outcomes:
measure: Percentage of Participants Who Meet Response Criteria for the SLE Responder Index : SRI(4), SRI(5) and SRI(6) at Day 169
timeFrame: At Day 169
measure: Percentage of Participants Who Meet Response Criteria for the SLE Responder Index: SRI(4), SRI(5) and SRI(6) at Day 85
timeFrame: At Day 85
measure: Percentage of Participants With BICLA Response (BICLA Response Rate) at Day 85
timeFrame: At Day 85
measure: Mean Change From Baseline in CLASI Score at Day 85 and Day 169
timeFrame: At Day 85 and Day 169
measure: 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
timeFrame: At Day 85 and Day 169
measure: 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
timeFrame: At baseline, Day 85 and Day 169
measure: Change From Baseline in BILAG-2004 Score of Systemic Lupus Erythematosus (SLE) Activity on Day 85 and Day 169
timeFrame: At baseline, Day 85 and Day 169
measure: Cumulative Corticosteroid and Immunosuppressant Use
timeFrame: 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
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Pre-established Events of Special Interest
timeFrame: 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
measure: Percentage of Participants With Clinically Significant Changes in Vital Signs:Heart Rate
timeFrame: At Day 85 and Day 169
measure: Percentage of Participants With Clinically Significant Changes in Vital Signs: Systolic and Diastolic Blood Pressure
timeFrame: At Day 85 and Day 169
measure: Percentage of Participants With Clinically Significant Changes in Vital Signs: Respiration Rate
timeFrame: At Day 85 and Day 169
measure: Percentage of Participants With Clinically Significant Changes in Vital Signs: Temperature
timeFrame: At Day 85 and Day 169
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: 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.
measure: Ctrough: Trough Level Serum Concentration of BMS-931699 at Time Point Specified
timeFrame: Day 169
measure: Serum Biomarkers C3, C4
timeFrame: At Day 85 and Day 169
measure: Serum Biomarkers: Anti-Nuclear Antibodies (ANA)
timeFrame: At Day 85 and Day 169
measure: Short Term: Receptor Occupancy Over Time
timeFrame: At Day 85 and Day 169
measure: Percentage of Participants With BMS-931699 Induced Antibody Response Over Time Point Specified
timeFrame: Day 169
measure: Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY I
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: HEMATOLOGY II
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests : LIVER FUNCTION TESTS
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants With Clinically Significant Abnormalities in General Laboratory Tests: KIDNEY FUNCTION TESTS
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants Clinically Significant Abnormalities in General Laboratory Tests ELECTROLYTES 1
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 2
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants Clinically Significant Abnormalities in General Laboratory Tests: ELECTROLYTES 3
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 1
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 2
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : OTHER CHEMISTRY TESTING 3
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : IMMUNOLOGY
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Number of Participants Clinically Significant Abnormalities in General Laboratory Tests : URINALYSIS
timeFrame: Up to 42 days post last dose of study medication in short-term or long-term extension period
measure: Change From Baseline in the SLEDAI-2K Score of SLE Activity on Day 85 and Day 169
timeFrame: At baseline, Day 85 and Day 169
measure: Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) on Day 85 and Day 169
timeFrame: At baseline, Day 85 and Day 169
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates Of North Alabama, P.C.
state: Alabama
city: Fullerton
country: United States
facility: St Jude Hospital Yorba Linda
state: California
city: Long Beach
country: United States
facility: Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Farmington
country: United States
facility: University Of Connecticut Health Center
state: Connecticut
city: Trumbull
country: United States
facility: Local Institution
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Center For Rheumatology, Immunology And Arthritis
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center
state: Florida
city: Decatur
country: United States
facility: Jefrey D. Lieberman, Md., Pc
state: Georgia
city: Coeur d'Alene
country: United States
facility: Coeur D'Alene Arthrit Clin
state: Idaho
city: Wichita
country: United States
facility: Heartland Research Associates, Llc
state: Kansas
city: Boston
country: United States
facility: Beth Israel Deaconess Med. Center Div. Of Gastroenterology
state: Massachusetts
city: Lincoln
country: United States
facility: Physician Research Collaboration, Llc
state: Nebraska
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials
state: New Mexico
city: Great Neck
country: United States
facility: North Shore Lij Health System
state: New York
city: Manhasset
country: United States
facility: The Feinstein Institute For Medical Research
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Joint and Muscle Medical Care and Research Institute (JMMCRI)
state: North Carolina
city: Salisbury
country: United States
facility: Pmg Research Of Salisbury
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation
state: Oklahoma
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, P.C.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute (Asri)
state: Pennsylvania
city: Austin
country: United States
facility: Tekton Research Inc
state: Texas
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Spokane
country: United States
facility: Arthritis Northwest
state: Washington
city: Capital Federal
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Hospital General De Agudos J.M. Ramos Mejia
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Instituto De Investigaciones Clinicas De Mar Del Plata
state: Buenos Aires
city: San Fernando
country: Argentina
facility: Instituto de Asistencia Reumatologica Integral
state: Buenos Aires
city: Rosario
country: Argentina
facility: Clinica De Reumatologia
state: Santa FE
city: Cordoba
country: Argentina
facility: Centro Consultora Integral de Salud SRL
city: Savaldor
country: Brazil
facility: Servicos Especializados em Reumatologia SER
state: Bahia
city: Goiania
country: Brazil
facility: Cip Pesquisas Medicas
state: Goias
city: Juiz de Fora
country: Brazil
facility: Centro Mineiro De Pesquisa
state: Minas Gerais
city: Varginha
country: Brazil
facility: Centro Medico Varginha
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Edumed - Educacao em Saude S/S LTDA
state: Parana
city: Porto Alegre
country: Brazil
facility: LMK Servicos Medicos S S Ltda
state: RIO Grande DO SUL
city: Sao Paulo
country: Brazil
facility: CPCLIN Centro de Pesquisas Clinicas LTDA
city: Sao Paulo
country: Brazil
facility: Lar Escola AACD
city: St. John's
country: Canada
facility: Karma Clinical Trials Inc.
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
city: Trois-rivieres
country: Canada
facility: Centre De Recherche Musculo-Squelettique
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec Research Centre
city: Santiago De Chile
country: Chile
facility: Centro De Estudios Reumatologicos
state: Metropolitana
city: Santiago
country: Chile
facility: Hospital San Borja Arriaran
state: Region Metropolitana
city: Bogota
country: Colombia
facility: Riesgo De Fractura
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Servimed E.U
state: Santander
city: Barranquilla
country: Colombia
facility: Clinica De La Costa
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Bordeaux Cedex
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Marseille
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Strasbourg
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Campus Charite Mitte
city: Freiburg
country: Germany
facility: Medizinsche Universitaetsklinik Freiburg
city: Heidelberg
country: Germany
facility: Universitaetshautklinik Heidelberg
city: Mainz
country: Germany
facility: Johannes Gutenberg - Universitaet
city: Budapest
country: Hungary
facility: Budai Irgalmasrendi Korhaz
city: Gyula
country: Hungary
facility: Infektologiai-Hepatologiai Osztaly
city: Szeged
country: Hungary
facility: Borgyogyaszati Klinika
city: Cona - Ferrara
country: Italy
facility: Arcispedale S. Anna
city: Milano
country: Italy
facility: Azienda Ospedaliera Luigi Sacco
city: Padova
country: Italy
facility: Azienda Ospedaliera Di Padova
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana
city: Roma
country: Italy
facility: Policlinico Umberto I
city: Chiba-shi
country: Japan
facility: Local Institution
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Kitakyushu-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Kanazawa-shi
country: Japan
facility: Local Institution
state: Ishikawa
city: Sendai
country: Japan
facility: Local Institution
state: Miyagi
city: Sasebo-shi
country: Japan
facility: Local Institution
state: Nagasaki
city: Shimotsuke-shi
country: Japan
facility: Local Institution
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Fuchu
country: Japan
facility: Local Institution
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Meguro-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Local Institution
state: Tokyo
city: Daejeon
country: Korea, Republic of
facility: Local Institution
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Beirut
country: Lebanon
facility: Local Institution
city: Tripoli
country: Lebanon
facility: Local Institution
city: Mexico City
country: Mexico
facility: CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
state: Distrito Fededral
city: Mexico
country: Mexico
facility: Instituto para el DeSarrollo Integral de la Salud S de RL de CV
state: Distrito Federal
city: León
country: Mexico
facility: Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia
state: Guanajuato
city: Guadalajara, Jalisco
country: Mexico
facility: Centro Integral En Reumatologia Sa De Cv
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica de Investigacion en Reumatologia y Obesidad S.C.
state: Jalisco
city: Villahermosa
country: Mexico
facility: Centro de Radiodiagnostico Computarizado Medico de Tabasco S.A. de C.V.
state: Tabasco
city: Distrito Federal
country: Mexico
facility: Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.
city: San Luis Potosi
country: Mexico
facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
city: Yucatan
country: Mexico
facility: Unidad Reumatologica Las Americas, S.C. P.
city: Den Haag
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Institution
city: Lima
country: Peru
facility: Clinica Anglo Americana
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia
city: Lima
country: Peru
facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
city: Lublin
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Medyczne Centrum Hetmanska Indywidualna Spec. Praktyka Lekar
city: Warszawa
country: Poland
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Bucharest
country: Romania
facility: Sf. Maria Clinical Hospital,Bucharest
city: Iasi
country: Romania
facility: Spitalul Clinic de Recuperare Iasi
city: St Petersburg
country: Russian Federation
facility: Local Institution
city: Tolyatti
country: Russian Federation
facility: Local Institution
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Soweto
country: South Africa
facility: Local Institution
state: Gauteng
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: Stellenbosch
country: South Africa
facility: Local Institution
state: Western CAPE
city: Madrid
country: Spain
facility: Hosp Univer 12 De Octubre
city: Malaga
country: Spain
facility: Hospital Carlos Haya De Malaga
city: Vigo
country: Spain
facility: Hospital Meixoeiro
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taoyuan
country: Taiwan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.