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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 : May 17, 2019
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

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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 : September 1, 2017
Estimated Primary Completion Date : July 20, 2020
Estimated Study Completion Date : July 21, 2020

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.


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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
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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 #.

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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    16193344764203      
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
Local Institution Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Site 0224         
Office of Wagdy W. Kades, M.D Recruiting
Los Angeles, California, United States, 90057
Contact: Wagdy Kades, Site 0205         
Local Institution Not yet recruiting
Orange, California, United States, 92868
Contact: 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
Harbor-University of California Los Angeles Medical Center - Torrance Recruiting
Torrance, California, United States, 90502
Contact: George Karpouzas, Site 0132         
Local Institution Not yet recruiting
Upland, California, United States, 91786
Contact: 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 Recruiting
Farmington, Connecticut, United States, 06030-5353
Contact: Santhanam Lakshminarayanan, Site 0034         
Yale University Recruiting
New Haven, Connecticut, United States, 06520
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         
University of Florida Health Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Michael Bubb, Site 0214         
Local Institution Not yet recruiting
Orlando, Florida, United States, 32808
Contact: Site 0233         
Millennium Research Recruiting
Ormond Beach, Florida, United States, 32174
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, 30308
Contact: Sung Sam Lim, Site 0206         
Local Institution Not yet recruiting
Decatur, Georgia, United States, 30033
Contact: Site 0022         
North Georgia Rheumatology Group-Duluth Recruiting
Lawrenceville, Georgia, United States, 30045
Contact: Theresa Lawrence-Ford, Site 0083    678-650-0474      
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 Recruiting
Cumberland, Maryland, United States, 21502
Contact: Steven Klein, Site 0018    301-724-4337      
Klein and Associates Recruiting
Hagerstown, Maryland, United States, 21740
Contact: Mary Howell, Site 0120    301-791-6680      
United States, Michigan
Advanced Rheumatology - Lansing Recruiting
Lansing, Michigan, United States, 48910
Contact: Monika Mohan, Site 0058    517-908-3609      
June D.O. PC Recruiting
Lansing, Michigan, United States, 48910
Contact: Joshua June, 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         
Local Institution Not yet recruiting
Brooklyn, New York, United States, 11203
Contact: Site 0085         
Northwell Health Recruiting
Lake Success, New York, United States, 11042
Contact: Meggan Mackay, Site 0082    516-562-2591      
Local Institution Not yet recruiting
New York, New York, United States, 10016
Contact: Site 0109         
Local Institution Not yet recruiting
New York, New York, United States, 10032-3729
Contact: 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
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, 15213
Contact: Site 0217         
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Site 0246         
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, 78726
Contact: Anurekha Chadha, Site 0087    512-344-0362      
Tekton Research Recruiting
Austin, Texas, United States, 78745
Contact: Paul Pickrell, Site 0086         
Accurate Clinical Management - Greenhouse Road Recruiting
Baytown, Texas, United States, 77521
Contact: Amber Khan, Site 0204         
Pioneer Research Solutions Recruiting
Beaumont, Texas, United States, 77702
Contact: Asif Cochinwala, Site 0007         
Local Institution Not yet recruiting
Dallas, Texas, United States, 75231
Contact: Site 0124         
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 Research-Stafford Recruiting
Houston, Texas, United States, 77034
Contact: Philip Waller, Site 0061    281-240-1045      
Southwest Rheumatology Research Recruiting
Mesquite, Texas, United States, 75150
Contact: Atul Singhal, Site 0047         
Arthritis and Osteoporosis Center of South Texas Recruiting
San Antonio, Texas, United States, 78232
Contact: John Huff, Site 0014         
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
Local Institution Recruiting
Caba, Buenos Aires, Argentina, C1114AAF
Contact: Site 0166         
Local Institution Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1430
Contact: Site 0139         
Local Institution Not yet recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425AGC
Contact: Site 0138         
Local Institution Not yet recruiting
Rosario, Santa FE, Argentina, 2000
Contact: Site 0152         
Local Institution Recruiting
San Miguel de Tucuman, Tucuman, Argentina, T4000AXL
Contact: Site 0097         
Local Institution Not yet recruiting
Buenos Aires, Argentina, 1046
Contact: Site 0185         
Local Institution Recruiting
Caba, Argentina, 1111
Contact: Site 0136         
Local Institution Not yet recruiting
Cordoba, Argentina, X5004FHP
Contact: Site 0096         
Local Institution Not yet recruiting
Cordoba, Argentina, X5016KEH
Contact: Site 0143         
Local Institution Recruiting
Mendoza, Argentina, 5500
Contact: Site 0137         
Australia, Queensland
Local Institution Not yet recruiting
Maroochydore, Queensland, Australia, 4558
Contact: Site 0241         
Australia, Victoria
Local Institution Not yet recruiting
Clayton, Victoria, Australia
Contact: Site 0243         
Local Institution Not yet recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Site 0244         
Brazil
Local Institution Not yet recruiting
Salvador, Bahia, Brazil, 40150-150
Contact: Site 0130         
Local Institution Not yet recruiting
Goiania, Goias, Brazil, 74110-120
Contact: Site 0129         
Local Institution Not yet recruiting
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Contact: Site 0153         
Local Institution Recruiting
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Contact: Site 0125         
Local Institution Recruiting
Curitiba, Parana, Brazil, 80030110
Contact: Site 0126         
Local Institution Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90035903
Contact: Site 0127         
Local Institution Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
Contact: Site 0128         
Local Institution Recruiting
Santo Andre, SAO Paulo, Brazil, 09190-510
Contact: Site 0151         
Local Institution Not yet recruiting
Rio de Janeiro, Brazil, 22411-001
Contact: Site 0131         
Local Institution Not yet recruiting
Sao Paulo, Brazil
Contact: 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
Local Institution Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Site 0247         
Local Institution Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z1
Contact: Site 0248         
Canada, Ontario
Local Institution Not yet recruiting
Hamilton, Ontario, Canada, L8S 4K1
Contact: Site 0249         
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5T 3A9
Contact: Site 0245         
Colombia
Local Institution Recruiting
Barranquilla, Colombia, 080002
Contact: Site 0098         
Local Institution Not yet recruiting
Barranquilla, Colombia
Contact: Site 0099         
Local Institution Not yet recruiting
Bogota, Colombia
Contact: Site 0145         
Local Institution Not yet recruiting
Bucaramanga, Colombia, 680003
Contact: Site 0231         
Local Institution Not yet recruiting
Cali, Colombia
Contact: Site 0161         
Local Institution Not yet recruiting
Chia, Colombia, 250001
Contact: Site 0100         
Local Institution Not yet recruiting
Medellin, Colombia, 050021
Contact: Site 0160         
Local Institution Recruiting
Zipaquira, Colombia, 250252
Contact: Site 0159         
France
Local Institution Not yet recruiting
LILLE Cedex, 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, France, 67098
Contact: Site 0165         
Local Institution Not yet recruiting
Toulouse, France, 31000
Contact: Site 0169         
Germany
Local Institution Recruiting
Berlin, Germany, D-10117
Contact: Site 0062         
Local Institution Recruiting
Hannover, Germany, 30625
Contact: Site 0164         
Local Institution Recruiting
Mainz, Germany, 55101
Contact: Site 0155         
Hungary
Local Institution Recruiting
Budapest, Hungary, 1097
Contact: Site 0019         
Local Institution Recruiting
Debrecen, Hungary, 4032
Contact: Site 0063         
Local Institution Recruiting
Gyula, Hungary, 5701
Contact: Site 0035         
Local Institution Recruiting
Szeged, Hungary, 6725
Contact: Site 0123         
Israel
Local Institution Recruiting
Haifa, Israel, 31048
Contact: Site 0030         
Local Institution Recruiting
Jerusalem, Israel, 91240
Contact: Site 0046         
Local Institution Recruiting
Kfar Saba, Israel, 49281
Contact: Site 0021         
Local Institution Recruiting
Petach-Tiqwa, Israel, 49100
Contact: Site 0112         
Local Institution Recruiting
Ramat Gan, Israel, 52621
Contact: Site 0203         
Japan
Local Institution Recruiting
Chiba-shi, Chiba, Japan, 260-8712
Contact: Site 0117         
Local Institution Recruiting
Kitakyushu, Fukuoka, Japan, 807-8556
Contact: Site 0177         
Local Institution Recruiting
Sapporo-shi, Hokkaido, Japan, 0608604
Contact: Site 0141         
Local Institution Recruiting
Sapporo-shi, Hokkaido, Japan, 0608648
Contact: Site 0110         
Local Institution Recruiting
Kanazawa-shi, Ishikawa, Japan, 9200934
Contact: Site 0095         
Local Institution Recruiting
Sendai-shi, Miyagi, Japan, 9808574
Contact: Site 0111         
Local Institution Recruiting
Tomigusuku-shi, Okinawa, Japan, 9010243
Contact: Site 0146         
Local Institution Recruiting
Shimotsuga-gun, Tochigi, Japan, 3210293
Contact: Site 0158         
Local Institution Recruiting
Shimotsuke-shi, Tochigi, Japan, 3290498
Contact: Site 0183         
Local Institution Recruiting
Bunkyo-ku, Tokyo, Japan, 1138431
Contact: Site 0162         
Local Institution Recruiting
Chuo-ku, Tokyo, Japan, 104-8560
Contact: Site 0154         
Local Institution Recruiting
Itabashi-ku, Tokyo, Japan, 1738610
Contact: Site 0144         
Local Institution Recruiting
Shinjuku-Ku, Tokyo, Japan, 1608582
Contact: Site 0181         
Local Institution Recruiting
Tokyo, Japan, 142-8666
Contact: Site 0170         
Local Institution Recruiting
Tokyo, Japan, 152-8902
Contact: Site 0118         
Local Institution Recruiting
Tokyo, Japan, 162-8655
Contact: Site 0133         
Korea, Republic of
Local Institution Recruiting
Daegu, Korea, Republic of, 700-721
Contact: Site 0053         
Local Institution Recruiting
Daejeon Metropolitan City, Korea, Republic of, 302-721
Contact: Site 0051         
Local Institution Recruiting
Gyeonggi-do, Korea, Republic of, 443-380
Contact: Site 0050         
Local Institution Recruiting
Incheon, Korea, Republic of, 22332
Contact: Site 0052         
Local Institution Recruiting
Seoul, Korea, Republic of, 03080
Contact: Site 0054         
Mexico
Local Institution Recruiting
Mexico City, Distrito Federal, Mexico, 06760
Contact: Site 0173         
Local Institution Recruiting
Mexico, Distrito Federal, Mexico, 11850
Contact: Site 0140         
Local Institution Recruiting
Leon, Guanajuato, Guanajuato, Mexico, 37000
Contact: Site 0163         
Local Institution Recruiting
Leon, Guanajuato, Mexico, 37120
Contact: Site 0172         
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44160
Contact: Site 0135         
Local Institution Recruiting
Zapopan, Jalisco, Mexico, 45030
Contact: Site 0156         
Local Institution Not yet recruiting
Zapopan, Jalisco, Mexico, 45116
Contact: Site 0175         
Local Institution Recruiting
Monterrey, Nuevo LEON, Mexico, 64000
Contact: Site 0134         
Local Institution Recruiting
San Luis Potosi, Mexico, 78213
Contact: Site 0149         
Local Institution Recruiting
Veracruz, Mexico, 91900
Contact: Site 0157         
Peru
Local Institution Withdrawn
Cercado De Lima, Lima, Peru
Local Institution Withdrawn
Lima, Peru, Lima 11
Local Institution Withdrawn
Lima, Peru
Poland
Local Institution Recruiting
Warszawa, Masovian, Poland, 00-660
Contact: Site 0219         
Local Institution Recruiting
Bydgoszcz, Poland, 85-168
Contact: Site 0089         
Local Institution Recruiting
Bytom, Poland, 41-902
Contact: Site 0215         
Local Institution Recruiting
Elblag, Poland, 82-300
Contact: Site 0031         
Local Institution Recruiting
Gdynia, Poland, 81-338
Contact: Site 0189         
Local Institution Withdrawn
Katowice, Poland, 40-282
Local Institution Not yet recruiting
Konskie, Poland, 26-200
Contact: Site 0221         
Local Institution Recruiting
Koscian, Poland, 64-000
Contact: Site 0182         
Local Institution Recruiting
Krakow, Poland, 30-363
Contact: Site 0211         
Local Institution Recruiting
Krakow, Poland, 31-011
Contact: Site 0222         
Local Institution Recruiting
Krakow, Poland, 31-637
Contact: Site 0220         
Local Institution Not yet recruiting
Lublin, Poland, 20-607
Contact: Site 0041         
Local Institution Not yet recruiting
Poznan, Poland, 60-218
Contact: Site 0020         
Local Institution Recruiting
Poznan, Poland, 60-529
Contact: Site 0191         
Local Institution Recruiting
Poznan, Poland, 60-693
Contact: Site 0218         
Local Institution Recruiting
Sosnowiec, Poland, 41-200
Contact: Site 0093         
Local Institution Not yet recruiting
Stalowa Wola, Poland, 37-450
Contact: Site 0012         
Local Institution Recruiting
Warszawa, Poland, 01-868
Contact: Site 0192         
Local Institution Recruiting
Warszawa, Poland, 02-691
Contact: Site 0090         
Local Institution Not yet recruiting
Warszawa, Poland, 03-291
Contact: Site 0239         
Local Institution Recruiting
Wroclaw, Poland, 50-088
Contact: Site 0077         
Local Institution Recruiting
Wroclaw, Poland, 51-685
Contact: Site 0184         
Local Institution Recruiting
Wroclaw, Poland, 52-416
Contact: Site 0025         
Romania
Local Institution Recruiting
Brasov, Romania, 500283
Contact: Site 0003         
Local Institution Recruiting
Bucharest, Romania, 011172
Contact: Site 0004         
Local Institution Recruiting
Bucharest, Romania, 011172
Contact: Site 0043         
Local Institution Recruiting
Bucuresti, Romania, 011025
Contact: Site 0198         
Local Institution Recruiting
Bucuresti, Romania, 020475
Contact: Site 0005         
Local Institution Recruiting
Cluj-Napoca, Romania, 400006
Contact: Site 0029         
Local Institution Recruiting
Galati, Romania, 800578
Contact: Site 0196         
Local Institution Recruiting
Ramnicu Valcea, Romania, 240277
Contact: Site 0015         
Russian Federation
Local Institution Recruiting
Ekaterinburg, Russian Federation, 620043
Contact: Site 0107         
Local Institution Recruiting
Kemerovo, Russian Federation, 650000
Contact: Site 0101         
Local Institution Recruiting
Kemerovo, Russian Federation, 650066
Contact: Site 0104         
Local Institution Not yet recruiting
Novosibirsk, Russian Federation, 630099
Contact: Site 0210         
Local Institution Recruiting
Orenburg, Russian Federation, 460018
Contact: Site 0006         
Local Institution Recruiting
Petrozavodsk, Russian Federation, 185019
Contact: Site 0024         
Local Institution Not yet recruiting
Saint - Petersburg, Russian Federation, 191045
Contact: Site 0207         
Local Institution Recruiting
Saint Petersburg, Russian Federation, 192007
Contact: Site 0105         
Local Institution Not yet recruiting
Saint Petersburg, Russian Federation, 194156
Contact: Site 0223         
Local Institution Recruiting
Saint-Petersburg, Russian Federation, 190068
Contact: Site 0103         
Local Institution Recruiting
Smolensk, Russian Federation, 214025
Contact: Site 0213         
Local Institution Not yet recruiting
Tolyatti, Russian Federation, 445039
Contact: Site 0212         
Local Institution Withdrawn
Vladimir, Russian Federation, 600023
Local Institution Not yet recruiting
Vladimir, Russian Federation, 600023
Contact: Site 0176         
Local Institution Recruiting
Yaroslavl, Russian Federation, 150002
Contact: Site 0208         
Local Institution Recruiting
Yatoslavl, Russian Federation, 150023
Contact: Site 0209         
Spain
Local Institution Not yet recruiting
A Coruna, Spain, 15006
Contact: Site 0237         
Local Institution Not yet recruiting
Barcelona, Spain, 08035
Contact: Site 0242         
Local Institution Not yet recruiting
Malaga, Spain, 29010
Contact: Site 0240         
Local Institution Not yet recruiting
Merida, Spain, 06800
Contact: Site 0238         
Local Institution Not yet recruiting
Sabadell (Barcelona), Spain, 08208
Contact: Site 0235         
Local Institution Not yet recruiting
Sevilla, Spain, 41014
Contact: 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, 883
Contact: Site 0226         
Local Institution Recruiting
Taichung, Taiwan, 402
Contact: Site 0114         
Local Institution Not yet recruiting
Taipei City, Taiwan, 10630
Contact: Site 0225         
Local Institution Recruiting
Taipei, Taiwan, 11031
Contact: Site 0092         
Local Institution Recruiting
Taipei, Taiwan, 11217
Contact: Site 0091         
Local Institution Recruiting
Taipei, Taiwan
Contact: Site 0088         
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 Withdrawn
Uzhgorod, Ukraine, 88000
Local Institution Not yet recruiting
Vinnitsya, Ukraine, 21029
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     History of Changes
Other Study ID Numbers: IM011-021
2017-001203-79 ( EudraCT Number )
First Posted: August 17, 2017    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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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