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An Investigational Study to Evaluate BMS-986165 in Patients With 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03252587
Recruitment Status : Recruiting
First Posted : August 17, 2017
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This study will investigate BMS-986165 to assess its effects in patients with systemic lupus erythematosus (SLE).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: BMS-986165 Other: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : April 4, 2021
Estimated Study Completion Date : April 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: BMS-986165 Dose 1 oral administration Drug: BMS-986165
administered orally

Experimental: BMS-986165 Dose 2 oral administration Drug: BMS-986165
administered orally

Experimental: BMS-986165 Dose 3 oral administration Drug: BMS-986165
administered orally

Placebo Comparator: Placebo oral administration Other: Placebo
administered orally




Primary Outcome Measures :
  1. Number of participants who meet response criteria for SLE Responder Index [SRI(4)] [ Time Frame: 32 weeks ]

Secondary Outcome Measures :
  1. Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline achieving a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score [ Time Frame: 32 weeks ]
  2. Change from baseline in the 40-joint count for tender, swollen, and tender + swollen joints [ Time Frame: 32 weeks ]
  3. Number of participants who achieve British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response [ Time Frame: 32 weeks ]
  4. Distribution of participants experiencing serious adverse events (SAEs) [ Time Frame: 32 weeks ]
  5. Distribution of participants experiencing adverse events (AEs) [ Time Frame: 32 weeks ]
  6. Distribution of participants experiencing abnormalities in laboratory testing [ Time Frame: 48 weeks ]
  7. Distribution of participants experiencing abnormalities in vital signs [ Time Frame: 48 weeks ]
  8. Distribution of participants experiencing abnormalities in electrocardiograms (ECGs) [ Time Frame: 48 weeks ]
  9. Maximum observed plasma concentration (Cmax) [ Time Frame: 48 weeks ]
  10. Time of maximum observed plasma concentration (Tmax) [ Time Frame: 48 weeks ]
  11. Trough observed plasma concentration (Ctrough) [ Time Frame: 48 weeks ]


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 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE and diagnosed ≥ 24 weeks before the screening visit
  • One of the following: antinuclear antibody (ANA) ≥ 1:80 or positive anti-double-stranded DNA (dsDNA) or positive anti-Smith (Sm)
  • Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points

Exclusion Criteria:

  • Subjects with drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
  • SLE overlap syndromes such as scleroderma and mixed connective tissue disease
  • Clinically significant abnormalities on chest x-ray or ECG
  • History of any significant drug allergy

Other protocol defined inclusion/exclusion criteria could apply


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): NCT03252587


Contacts
Layout table for location contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
Hide Hide 240 study locations
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United States, Alabama
University of Alabama at Birmingham - School of Medicine Recruiting
Birmingham, Alabama, United States, 35294-2182
Contact: Walter Chatham, Site 0178         
United States, Arkansas
Little Rock Diagnostic Clinic Active, not recruiting
Little Rock, Arkansas, United States, 72205
United States, California
TriWest Research Associates Recruiting
El Cajon, California, United States, 92020
Contact: Arthur Mabaquiao, Site 0023    619-334-4762      
BioSolutions Clinical Research Center Recruiting
La Mesa, California, United States, 91942
Contact: Ara Dikranian, Site 0032         
Arthritis and Osteoporosis Medical Center-La Palma Withdrawn
La Palma, California, United States, 90623
Office of Wagdy W. Kades, M.D Recruiting
Los Angeles, California, United States, 90017
Contact: Wagdy Kades, Site 0205         
Los Angeles County Hospital and University of Southern California Medical Center Recruiting
Los Angeles, California, United States, 90033
Contact: William Stohl, Site 0224         
University of California at Irvine College of Medicine Recruiting
Orange, California, United States, 92868
Contact: Sheetal Desai, Site 0202         
Desert Medical Advances Recruiting
Palm Desert, California, United States, 92260
Contact: Maria Greenwald, Site 0227         
Local Institution Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Site 0199         
Millennium Clinical Trials - Thousand Oaks Active, not recruiting
Thousand Oaks, California, United States, 91360
The Lundquist Institute at Harbor-UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: George Karpouzas, Site 0132         
Inland Rheumatology Clinical Trials Recruiting
Upland, California, United States, 91786
Contact: Eric Lee, Site 0229         
United States, Colorado
University of Colorado School of Medicine Withdrawn
Aurora, Colorado, United States, 80045
United States, Connecticut
University of Connecticut Health Center - New England Musculoskeletal Institute - Farmington Active, not recruiting
Farmington, Connecticut, United States, 06030-5353
Yale University Recruiting
New Haven, Connecticut, United States, 06520-8018
Contact: Fotios Koumpouras, Site 0195         
United States, Florida
Arthritis & Rheumatic Disease Specialties Recruiting
Aventura, Florida, United States, 33180
Contact: Norman Gaylis, Site 0010    305-932-4162      
Bay Area Arthritis and Osteoporosis Recruiting
Brandon, Florida, United States, 33511
Contact: Vipul Joshi, Site 0066    813-651-4441      
University of Florida Health Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Michael Bubb, Site 0214         
Omega Research Group - Orlando Recruiting
Orlando, Florida, United States, 32808
Contact: Kwabena Ayesu, Site 0233         
Millennium Research Recruiting
Ormond Beach, Florida, United States, 32174-1139
Contact: Michael Kohen, Site 0057    386-672-1985      
West Broward Rheumatology Associates Recruiting
Tamarac, Florida, United States, 33321
Contact: Alan Alberts, Site 0002    954-545-8400      
Local Institution Not yet recruiting
Tampa, Florida, United States, 33603
Contact: Site 0065         
Advent Health Medical Group Recruiting
Tampa, Florida, United States, 33613
Contact: Kimberly Smith, Site 0038    813-494-3254      
BayCare Medical Group Recruiting
Tampa, Florida, United States, 33614
Contact: Michael Burnette, Site 0234         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: Sung Sam Lim, Site 0206         
Jefrey D. Lieberman, MD., PC Recruiting
Decatur, Georgia, United States, 30033
Contact: Jefrey Lieberman, Site 0022         
North Georgia Rheumatology Group-Duluth Recruiting
Lawrenceville, Georgia, United States, 30045
Contact: Theresa Lawrence-Ford, Site 0083    17708221090114      
Arthritis Research and Treatment Center Recruiting
Stockbridge, Georgia, United States, 30281
Contact: Maria Fondal, Site 0094         
United States, Indiana
Rehabilitation Associates of Indiana Withdrawn
Indianapolis, Indiana, United States, 46250
United States, Maryland
Klein & Associates Active, not recruiting
Cumberland, Maryland, United States, 21502
Klein and Associates Recruiting
Hagerstown, Maryland, United States, 21740
Contact: Mary Howell, Site 0120    130179166801136      
United States, Michigan
Advanced Rheumatology - Lansing Active, not recruiting
Lansing, Michigan, United States, 48910
Local Institution Not yet recruiting
Lansing, Michigan, United States, 48910
Contact: Site 0016         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455-0341
Contact: Parastoo Fazeli, Site 0187         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Vikas Majithia, Site 0216         
United States, New Jersey
Local Institution Not yet recruiting
Freehold, New Jersey, United States, 07728
Contact: Site 0186         
United States, New York
Weill Cornell Physicians at Brooklyn Recruiting
Brooklyn, New York, United States, 11201
Contact: David Goddard, Site 0011         
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Olga Dvorkina, Site 0085         
Northwell Health Recruiting
Lake Success, New York, United States, 11042
Contact: Meggan Mackay, Site 0082    516-562-2591      
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Amit Saxena, Site 0109         
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Laura Geraldino-Pardilla, Site 0232         
Local Institution Not yet recruiting
Rochester, New York, United States, 14642
Contact: Site 0194         
Local Institution Not yet recruiting
Syracuse, New York, United States, 13210-2342
Contact: Site 0028         
United States, North Carolina
Thurston Arthritis Research Center Recruiting
Chapel Hill, North Carolina, United States, 27599-7280
Contact: Saira Sheikh, Site 0119         
Joint and Muscle Research Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Alireza Nami, Site 0026    704-248-8577      
Shanahan Rheumatology and Immunotherapy Withdrawn
Raleigh, North Carolina, United States, 27617
United States, Oklahoma
Arthritis & Rheumatology Center of Oklahoma Recruiting
Oklahoma City, Oklahoma, United States, 73101
Contact: Mohammad Khan, Site 0180         
Oklahoma Medical Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Cristina Arriens, Site 0197         
Local Institution Not yet recruiting
Tulsa, Oklahoma, United States, 74104
Contact: Site 0230         
United States, Pennsylvania
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Site 0200         
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site 0246         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Kimberly Liang, Site 0217         
Clinical Research Center of Reading Recruiting
Wyomissing, Pennsylvania, United States, 19610
Contact: Nancy Walker, Site 0174         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Eric Zollars, Site 0190    843-792-6043      
Local Institution Not yet recruiting
Orangeburg, South Carolina, United States, 29118
Contact: Site 0009         
United States, Tennessee
West Tennessee Research Institute Recruiting
Jackson, Tennessee, United States, 38305
Contact: Jacob Aelion, Site 0001         
University of Tennessee Health Science Center Recruiting
Memphis, Tennessee, United States, 38163
Contact: Debendra Pattanaik, Site 0073         
United States, Texas
Austin Regional Clinic Recruiting
Austin, Texas, United States, 78731-3146
Contact: Anurekha Chadha, Site 0087    512-344-0362      
Tekton Research Recruiting
Austin, Texas, United States, 78745
Contact: Paul Pickrell, Site 0086         
Pioneer Research Solutions Recruiting
Cypress, Texas, United States, 77429-5890
Contact: Asif Cochinwala, Site 0007         
Baylor Research Institute Active, not recruiting
Dallas, Texas, United States, 75231
Local Institution Not yet recruiting
Dallas, Texas, United States, 75231
Contact: Site 0081         
UTSW Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David Karp, Site 0193         
Accurate Clinical Management - Greenhouse Road Recruiting
Houston, Texas, United States, 77084
Contact: Amber Khan, Site 0204         
Accurate Clinical Research Recruiting
Houston, Texas, United States, 77089
Contact: Philip Waller, Site 0061    281-481-8557      
Southwest Rheumatology Research Recruiting
Mesquite, Texas, United States, 75150
Contact: Atul Singhal, Site 0047         
Arthritis and Osteoporosis Center of South Texas Active, not recruiting
San Antonio, Texas, United States, 78232
United States, Virginia
The Center for Arthritis and Rheumatic Diseases Recruiting
Chesapeake, Virginia, United States, 23320
Contact: Roger Lidman, Site 0171         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Kwanghoon Han, Site 0201         
Arthritis Northwest, PLLC Recruiting
Spokane, Washington, United States, 99204
Contact: Howard Kenney, Site 0017         
Argentina
Investigaciones Reumatologicas y Osteologicas SRL Recruiting
Caba, Buenos Aires, Argentina, C1114AAF
Contact: Osvaldo Messina, Site 0166         
Aprillus Asistencia e Investigacion Recruiting
Ciudad Aut? De Buenos Aires, Buenos Aires, Argentina, C1046AAQ
Contact: Pablo Alejandro Mannucci Walter, Site 0185         
Consultorios Medicos Doctor Catalan Pellet Recruiting
Ciudad Aut? De Buenos Aires, Buenos Aires, Argentina, C1111AAL
Contact: Anastasia Secco, Site 0136         
Clinica Adventista Belgrano Recruiting
Ciudad Aut? De Buenos Aires, Buenos Aires, Argentina, C1430EGF
Contact: Federico Ariel, Site 0139         
Local Institution Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425AGC
Contact: Site 0138         
Instituto CAICI Recruiting
Rosario, Santa FE, Argentina, 2000
Contact: Norberto Quagliato, Site 0152         
Centro Medico Privado de Reumatologia Recruiting
San Miguel De Tucum, Tucuman, Argentina, T4000AXL
Contact: Alberto Spindler, Site 0097         
Local Institution Not yet recruiting
Buenos Aires, Argentina, C1015ABO
Contact: Site 0188         
Consultora Integral de Salud - Centro Medico Privado Recruiting
Cordoba, Argentina, X5004FHP
Contact: Veronica Savio, Site 0096         
Hospital Privado Centro Medico de Cordoba Recruiting
Cordoba, Argentina, X5016KEH
Contact: Veronica Saurit, Site 0143         
Instituto de Reumatologia Recruiting
Mendoza, Argentina, 5500
Contact: Alfredo Luis Borgia, Site 0137         
Australia, Queensland
Rheumatology Research Unit - Maroochydore Recruiting
Maroochydore, Queensland, Australia, 4558
Contact: Peter Nash, Site 0241         
Australia, Victoria
Local Institution Not yet recruiting
Clayton, Victoria, Australia
Contact: Site 0243         
Local Institution Not yet recruiting
Heidelberg West, Victoria, Australia, 3081
Contact: Site 0244         
Brazil
SER - Servicos Especializados em Reumatologia da Bahia Recruiting
Salvador, Bahia, Brazil, 40150-150
Contact: Mittermayer Santiago, Site 0130         
CIP - Centro Internacional de Pesquisa Recruiting
Goiߡ, Goias, Brazil, 74110-120
Contact: Antonio Carlos Ximenes, Site 0129         
Santa Casa de Misericordia de Belo Horizonte Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30150-223
Contact: Mariana de Souza, Site 0153         
Centro Mineiro de Pesquisa - CMiP Recruiting
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Contact: Silviane Vassalo, Site 0125         
CETI-UFPR Centro de Estudos em Terapias Inovadoras Recruiting
Curitiba, Parana, Brazil, 80030-110
Contact: Sebastiao Cezar Radominski, Site 0126         
LMK Servicos Medicos S/S Ltda Recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
Contact: Mauro Keiserman, Site 0128         
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, SAO Paulo, Brazil, 90035-903
Contact: Odirlei Monticielo, Site 0127         
Centro Multidisciplinar de Estudos Clinicos Recruiting
S?ernardo Do Campo, SAO Paulo, Brazil, 09715-090
Contact: Anna Maura Ferreira Fernandes, Site 0151         
CITIPA - Centro de Imunoterapia de Ipanema Recruiting
Rio de Janeiro, Brazil, 22221-020
Contact: Marcelo Pacheco, Site 0131         
CPCLIN - Centro de Pesquisas Clinicas Recruiting
Sao Paulo, Brazil, 01228-200
Contact: Flora Marcolino, Site 0148         
Bulgaria
Local Institution Withdrawn
Sliven, Bulgaria, 8800
Local Institution Not yet recruiting
Sofia, Bulgaria, 1431
Contact: Site 0036         
Local Institution Withdrawn
Sofia, Bulgaria, 1431
Local Institution Not yet recruiting
Sofia, Bulgaria, 1606
Contact: Site 0027         
Local Institution Withdrawn
Sofia, Bulgaria, 1612
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Ann Clarke, Site 0247         
Kaye Edmonton Clinic Recruiting
Edmonton, Alberta, Canada, T6G 1Z1
Contact: Stephanie Keeling, Site 0248         
Canada, Ontario
McMaster University Medical Centre Recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Mark Matsos, Site 0249         
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Zahi Touma, Site 0245         
Colombia
Centro Integral de Reumatologia Circaribe Recruiting
Barranquilla, Colombia, 080002
Contact: Elias Gonzalo Forero Illera, Site 0098         
Centro de Investigacion Medico Asistencial CIMEDICAL Recruiting
Barranquilla, Colombia
Contact: Juan Jaller-Raad, Site 0099         
Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM) Recruiting
Bogota, Colombia
Contact: Patricia Julieta Velez Sanchez, Site 0145         
Medicity SAS Recruiting
Bucaramanga, Colombia, 680003
Contact: Diego Saaibi Solano, Site 0231         
Clinica de Artritis Temprana Recruiting
Cali, Colombia
Contact: Alvaro Arbelaez Cortes, Site 0161         
Preventive Care Recruiting
Chia, Colombia, 250001
Contact: John Dario Londono Patino, Site 0100         
Local Institution Not yet recruiting
Medellin, Colombia, 050021
Contact: Site 0160         
Healthy Medical Center Recruiting
Zipaquira, Colombia, 250252
Contact: Danny Gomez Mora, Site 0159         
France
Local Institution Not yet recruiting
Lille, France, 59037
Contact: Site 0122         
Local Institution Not yet recruiting
Marseille, France, 13005
Contact: Site 0042         
Local Institution Not yet recruiting
Montpellier Cedex 5, France, 34295
Contact: Site 0167         
Local Institution Not yet recruiting
Paris, France, 75014
Contact: Site 0168         
Local Institution Not yet recruiting
Strasbourg Cedex, France, 67098
Contact: Site 0165         
Local Institution Not yet recruiting
Toulouse, France, 31000
Contact: Site 0169         
Germany
Allergie-Centrum-Charite Campus Charite Mitte Klinik fur Dermatologie Venerologie und Allergologi Active, not recruiting
Berlin, Germany, D-10117
Klinik fur Nieren- und Hochdruckerkrankungen Recruiting
Hannover, Germany, 30625
Contact: Hermann Haller, Site 0164         
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz - I. Medizinische Klinik und Poliklin Recruiting
Mainz, Germany, 55131
Contact: Wiebke Kaluza-Schilling, Site 0155         
Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet Recruiting
Budapest, Hungary, 1097
Contact: Janos Kadar, Site 0019         
Debreceni Egyetem Klinikai Kozpont Recruiting
Debrecen, Hungary, 4032
Contact: Tunde Tarr, Site 0063         
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz Recruiting
Gyula, Hungary, 5700
Contact: Tibor Martyin, Site 0035         
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Recruiting
Szeged, Hungary, 6725
Contact: Laszlo Kovacs, Site 0123         
Israel
Local Institution Recruiting
Haifa, Israel, 33394
Contact: Site 0030         
Local Institution Recruiting
Jerusalem, Israel, 9122001
Contact: Site 0046         
Local Institution Recruiting
Kfar Saba, Israel, 4428164
Contact: Site 0021         
Local Institution Recruiting
Petah Tikva, Israel, 4941492
Contact: Site 0112         
Local Institution Recruiting
Tel-Hashomer, Israel, 52621
Contact: Site 0203         
Japan
National Hospital Organization Chiba-East-Hospital Recruiting
Chiba-shi, Chiba, Japan, 260-8712
Contact: Ryutaro Matsumura, Site 0117         
Kameda Clinic Recruiting
Kamogawa-shi, Chiba, Japan, 296-0041
Contact: Ryo Rokutanda, Site 0250         
Hospital of the University of Occupational and Environmental Health Japan Recruiting
Kitakyushu, Fukuoka, Japan, 807-8556
Contact: Shingo Nakayamada, Site 0177         
Sapporo City General Hospital Recruiting
Sapporo-shi, Hokkaido, Japan, 0608604
Contact: Masaya Mukai, Site 0141         
Hokkaido University Hospital Recruiting
Sapporo-shi, Hokkaido, Japan, 0608648
Contact: Tatsuya Atsumi, Site 0110         
Kanazawa University Hospital Recruiting
Kanazawa, Ishikawa, Japan
Contact: Mitsuhiro Kawano, Site 0095         
Tohoku University Hospital Recruiting
Sendai City, Miyagi, Japan, 980-8574
Contact: Tomonori Ishii, Site 0111         
Tomishiro Central Hospital Recruiting
Tomigusuku-shi, Okinawa, Japan, 9010243
Contact: Yoshiki Shiohira, Site 0146         
Dokkyo Medical University Recruiting
Shimotsuga-gun, Tochigi, Japan, 3210293
Contact: Kazuhiro Kurasawa, Site 0158         
Jichi Medical University Hospital Recruiting
Shimotsuke-city, Tochigi, Japan, 329-0498
Contact: Yasuyuki Kamata, Site 0183         
St Lukes International Hospital Recruiting
Chuo-ku, Tokyo, Japan, 104-8560
Contact: Masato Okada, Site 0154         
Nihon University Itabashi Hospital Recruiting
Itabashi-ku, Tokyo, Japan, 1738610
Contact: Noboru Kitamura, Site 0144         
Keio University Hospital Recruiting
Shinjuku-Ku, Tokyo, Japan, 1608582
Contact: Yuko Kaneko, Site 0181         
Juntendo University Hospital Recruiting
Tokyo, Japan, 113-8431
Contact: Naoto Tamura, Site 0162         
Showa University Hospital Recruiting
Tokyo, Japan, 142-8666
Contact: Nobuyuki Yajima, Site 0170         
National Hospital Organization Tokyo Medical Center Recruiting
Tokyo, Japan, 152-8902
Contact: Hisaji Oshima, Site 0118         
Center Hospital of the National Center for Global Health and Medicine Recruiting
Tokyo, Japan, 162-8655
Contact: Hiroshi Kaneko, Site 0133         
Korea, Republic of
Local Institution Recruiting
Daegu, Korea, Republic of, 41944
Contact: Site 0053         
Local Institution Recruiting
Daegu, Korea, Republic of, 42601
Contact: Site 0252         
Local Institution Recruiting
Daejeon, Korea, Republic of, 35015
Contact: Site 0051         
Local Institution Recruiting
Gwangju, Korea, Republic of, 61469
Contact: Site 0253         
Local Institution Recruiting
Incheon, Korea, Republic of, 400-711
Contact: Site 0052         
Local Institution Recruiting
Seoul, Korea, Republic of, 03080
Contact: Site 0054         
Local Institution Recruiting
Suwon, Korea, Republic of, 16499
Contact: Site 0050         
Mexico
Centro de Investigacion y Tratamiento Reumatologico Recruiting
Mexico City, Distrito Federal, Mexico, 11850
Contact: Fedra Consuelo Irazoque Palazuelos, Site 0140         
CAIMED Investigacion en Salud Recruiting
Mexico, Distrito Federal, Mexico, 06760
Contact: Ingrid Juarez Mora, Site 0173         
Consultorio Medico de Reumatologia Recruiting
Leon, Guanajuato, Guanajuato, Mexico, 37000
Contact: Jesus Alberto Lopez Garcia, Site 0163         
Centro de Investigacion Farmacologica del Bajio Recruiting
Leon, Guanajuato, Mexico, 37160
Contact: Leonel Daza Benitez, Site 0172         
Centro Integral de Reumatologia Recruiting
Guadalajara, Jalisco, Mexico, 44160
Contact: Hilario Avila Armengol, Site 0135         
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Recruiting
Zapopan, Jalisco, Mexico, 45030
Contact: Adriana Sanchez Ortiz, Site 0156         
Juan Alberto Rodriguez Ruiz Recruiting
Zapopan, Jalisco, Mexico, 45116
Contact: Juan Rodriguez Ruiz, Site 0175         
Accelerium Clinical Research Recruiting
Monterrey, Nuevo LEON, Mexico, 64000
Contact: Edmundo Hector De la Garza Ramos, Site 0134         
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi Recruiting
San Luis Potosi, Mexico, 78213
Contact: Juan Cruz Rizo Rodriguez, Site 0149         
Faicic S. de R.L. de C.V. Recruiting
Veracruz, Mexico, 91900
Contact: Oscar Faibre Alvarez, Site 0157         
Peru
Local Institution Withdrawn
Cercado De Lima, Lima, Peru
Local Institution Withdrawn
Lima, Peru, Lima 11
Local Institution Withdrawn
Lima, Peru
Poland
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy Recruiting
Bydgoszcz, Poland, 85-168
Contact: Slawomir Jeka, Site 0089         
Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C Recruiting
Bytom, Poland, 41-902
Contact: Hanna Mastalerz, Site 0215         
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska Recruiting
Elbl?g, Poland, 82-300
Contact: Jan Brzezicki, Site 0031         
Centrum Medyczne Pratia w Gdyni Recruiting
Gdynia, Poland, 81-338
Contact: Anna Sylwestrzak, Site 0189         
Silmedic Sp. z o.o. Withdrawn
Katowice, Poland, 40-282
Intermedius Recruiting
Ko?cian, Poland, 64-000
Contact: Agata Wytyk-Nowak, Site 0182         
Zespol Opieki Zdrowotnej w Konskich Recruiting
Ko?skie, Poland, 26-200
Contact: Zbigniew Guzera, Site 0221         
Centrum Medyczne Plejady Recruiting
Krakow, Poland, 30-363
Contact: Magdalena Celinska-Lowenhoff, Site 0211         
Centrum Nowoczesnych Terapii Dobry Lekarz Spolka z ograniczona odpowiedzialnoscia Recruiting
Krak, Poland, 31-011
Contact: Wojciech Sydor, Site 0222         
Centrum Medyczne ProMiMed Recruiting
Krak, Poland, 31-637
Contact: Beata Sliwowska, Site 0220         
REUMED Sp. z o.o. Recruiting
Lublin, Poland, 20-607
Contact: Robert Zwolak, Site 0041         
Solumed Centrum Medyczne Recruiting
Pozna?, Poland, 60-529
Contact: Zygmunt Adamski, Site 0191         
Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Med-Polonia Recruiting
Pozna?, Poland, 60-693
Contact: Maria Jaraczewska-Baumann, Site 0218         
Medyczne Centrum Hetmanska - Poznan Recruiting
Poznan, Poland, 60-218
Contact: Piotr Leszczynski, Site 0020         
Centrum Medyczne Medens - Grupowa Praktyka Lekarska Recruiting
Sosnowiec, Poland, 41-200
Contact: Przemyslaw Kotyla, Site 0093         
SANUS Szpital Specjalistyczny Recruiting
Stalowa Wola, Poland, 37-450
Contact: Zbigniew Gola, Site 0012         
Medycyna Kliniczna Recruiting
Warszawa, Poland, 00-874
Contact: Malgorzata Socik-Pojawa, Site 0219         
Centrum Medyczne Pratia Warszawa Recruiting
Warszawa, Poland, 01-868
Contact: Katarzyna Romanowska-Prochnicka, Site 0192         
Ars Rheumatica - Reumatika Centrum Reumatologii Recruiting
Warszawa, Poland, 02-691
Contact: Janusz Jaworski, Site 0090         
Centrum Medyczne AMED Warszawa Targowek Recruiting
Warszawa, Poland, 03-291
Contact: Anna Dudek, Site 0239         
WroMedica Recruiting
Wroc?aw, Poland, 51-685
Contact: Wojciech Baran, Site 0184         
Centrum Medyczne Oporow Recruiting
Wroc?aw, Poland, 52-416
Contact: Maria Misterska-Skora, Site 0025         
Synexus Polska - Wroclaw Recruiting
Wroclaw, Poland, 50-381
Contact: Ewa Krecipro-Nizinska, Site 0077         
Romania
Neomed Research Recruiting
Brasov, Romania, 500283
Contact: Laurentia Doina Andrei, Site 0003         
Centrul Medical Sana Recruiting
Bucuresti, Romania, 011025
Contact: Cristina Pop, Site 0198         
Spitalul Sfanta Maria Recruiting
Bucuresti, Romania, 011172
Contact: Florian Berghea, Site 0004         
Spitalul Sfanta Maria Recruiting
Bucuresti, Romania, 011172
Contact: Maria-Ruxandra Ionescu, Site 0043         
Spitalul Clinic Dr. Ioan Cantacuzino Recruiting
Bucuresti, Romania, 020475
Contact: Mihai Bojinca, Site 0005         
Spitalul Clinic Judetean de Urgenta Cluj-Napoca Recruiting
Cluj-Napoca, Romania, 400006
Contact: Simona Rednic, Site 0029         
Spitalul Clinic Judeߥan de Urgenߡ Sfantul Apostol Andrei Recruiting
Galati, Romania, 800578
Contact: Mariana Pavel, Site 0196         
Spitalul Judetean de Urgenta Valcea Recruiting
R?cu V?a, Romania, 240277
Contact: Razvan Ionitescu, Site 0015         
Russian Federation
CjSC Recruiting
Ekaterinburg, Russian Federation, 620043
Contact: Tatiana Popova, Site 0107         
Kemerovo State Medical University Recruiting
Kemerovo, Russian Federation, 650000
Contact: Tatiana Raskina, Site 0101         
Medical Center Maksimum Zdorovia Recruiting
Kemerovo, Russian Federation, 650066
Contact: Svetlana Polyakova, Site 0104         
Medical Center Health Family Recruiting
Novosibirsk, Russian Federation, 630099
Contact: Elena Zonova, Site 0210         
Orenburg State Medical University Recruiting
Orenburg, Russian Federation, 460018
Contact: Olga Bugrova, Site 0006         
State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova Recruiting
Petrozavodsk, Russian Federation, 185019
Contact: Irina Marusenko, Site 0024         
Military Medical Academy S.M. Kirov Recruiting
Saint - Petersburg, Russian Federation, 191045
Contact: Alexander Gordienko, Site 0207         
Polyclinic of Private Security Personnel Recruiting
Saint Petersburg, Russian Federation, 192007
Contact: Olga Shmanovskaya, Site 0105         
Clinical Rheumatological Hospital Number 25 Recruiting
Saint-Petersburg, Russian Federation, 190068
Contact: Elena Ushakova, Site 0103         
Private Healthcare Institution Clinical Hospital Recruiting
Smolensk, Russian Federation, 214025
Contact: Diana Krechikova, Site 0213         
Federal Almazov North-West Medical Research Centre Recruiting
St. Petersburg, Russian Federation, 197341
Contact: Alexey Maslyanskiy, Site 0223         
Tolyatti city clinical hospital ? Recruiting
Tolyatti, Russian Federation, 445039
Contact: Lyudmila Grebenkina, Site 0212         
Biomed Recruiting
Vladimir, Russian Federation, 600005
Contact: Natalya Nikulenkova, Site 0176         
Local Institution Not yet recruiting
Vladimir, Russian Federation, 600005
Contact: Site 0102         
Clinical Hospital named after NA Semashko Recruiting
Yaroslavl, Russian Federation, 150002
Contact: Petr Chizhov, Site 0208         
State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2 Recruiting
Yatoslavl, Russian Federation, 150023
Contact: Natalia Shilkina, Site 0209         
Spain
Complejo Hospitalario Universitario A Coruna Recruiting
A Coru, Spain, 15006
Contact: Francisco Blanco Garcia, Site 0237         
Hospital Universitari Vall dHebron Recruiting
Barcelona, Spain, 08035
Contact: Josefina Cortes Hernandez, Site 0242         
Hospital de Merida Recruiting
M?a, Spain, 06800
Contact: Eugenio Chamizo Carmona, Site 0238         
Hospital Regional Universitario de Malaga Hospital General Recruiting
Malaga, Spain, 29010
Contact: Antonio Fernandez-Nebro, Site 0240         
Corporacio Sanitaria Parc Tauli Recruiting
Sabadell, Spain, 08208
Contact: Carlos Galisteo, Site 0235         
Hospital Universitario Nuestra Senora de Valme Recruiting
Sevilla, Spain, 41014
Contact: Jose Luis Marenco, Site 0228         
Local Institution Not yet recruiting
Valencia, Spain, 46026
Contact: Site 0236         
Taiwan
Local Institution Recruiting
Changhua City, Taiwan, 500
Contact: Site 0084         
Local Institution Not yet recruiting
Kaohsiung, Taiwan, 833
Contact: Site 0226         
Local Institution Recruiting
Taichung, Taiwan, 40201
Contact: Site 0114         
Local Institution Recruiting
Taipei City, Taiwan, 10630
Contact: Site 0225         
Local Institution Recruiting
Taipei, Taiwan, 10002
Contact: Site 0088         
Local Institution Recruiting
Taipei, Taiwan, 110
Contact: Site 0092         
Local Institution Recruiting
Taipei, Taiwan, 11217
Contact: Site 0091         
Local Institution Recruiting
Taoyuan, Taiwan, 333
Contact: Site 0251         
Ukraine
Local Institution Withdrawn
Ivano-Frankivsk, Ukraine, 76018
Local Institution Withdrawn
Kiev, Ukraine, 1601
Local Institution Not yet recruiting
Kyiv, Ukraine, 04071
Contact: Site 0055         
Local Institution Withdrawn
Lviv, Ukraine, 79010
Local Institution Not yet recruiting
Ternopil, Ukraine, 46001
Contact: Site 0071         
Local Institution Withdrawn
Uzhgorod, Ukraine, 88000
Local Institution Not yet recruiting
Vinnytsia, Ukraine, 21009
Contact: Site 0056         
Local Institution Withdrawn
Vinnytsia, Ukraine, 21018
Local Institution Not yet recruiting
Vinnytsya, Ukraine, 21001
Contact: Site 0037         
Local Institution Withdrawn
Vinnytsya, Ukraine, 21001
Local Institution Withdrawn
Zhytomyr, Ukraine, 10002
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03252587    
Other Study ID Numbers: IM011-021
2017-001203-79 ( EudraCT Number )
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
BMS-986165
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action