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An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis

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: NCT03943147
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of BMS-986165compared with placebo with regard to measures of kidney function in participants with lupus nephritis (LN).

Condition or disease Intervention/treatment Phase
Lupus Nephritis Drug: BMS-986165 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double-blind Study
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Efficacy of BMS-986165 With Background Treatment in Subjects With Lupus Nephritis
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : January 27, 2023
Estimated Study Completion Date : January 27, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose 1
Specified Dose on Specified Days
Drug: BMS-986165
Specified dose on specified days

Experimental: Dose 2
Specified Dose on Specified Days
Drug: BMS-986165
Specified dose on specified days

Placebo Comparator: Placebo
Specified Dose on Specified Days
Drug: Placebo
Specified dose on specified days




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 73 Weeks ]
  2. Incidence of laboratory abnormalites [ Time Frame: 73 Weeks ]
  3. Partial Renal Response (PRR) [ Time Frame: At Week 24 ]

Secondary Outcome Measures :
  1. Complete renal response (CRR) [ Time Frame: At Week 24 and Week 52 ]
  2. CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 24 and Week 52 ]
  3. Partial renal response (PRR) [ Time Frame: At Week 52 ]
  4. Mean Change from Baseline in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) [ Time Frame: At Week 24 and Week 52 ]
  5. Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg [ Time Frame: At Week 24 and Week 52 ]
  6. Urine Protein:Creatinine Ratio (UPCR) ≤ 0.7 mg/mg [ Time Frame: At Week 24 and Week 52 ]
  7. Change from baseline in Serum Creatinine [ Time Frame: At Week 24 and Week 52 ]
  8. Change from baseline in estimated glomerular filtration rate [ Time Frame: At Week 24 and Week 52 ]
  9. Change from baseline in serum Albumin [ Time Frame: At Week 24 and Week 52 ]
  10. Change from baseline in 24 hour UPCR [ Time Frame: At Week 24 and Week 52 ]
  11. CRR in the presence of low-dose CS (≤ 5 mg/day) [ Time Frame: At Week 24 and Week 52 ]
  12. PRR in the presence of low-dose CS (≤ 5 mg/day) [ Time Frame: At Week 24 and Week 52 ]
  13. CRR in participants who are able to completely taper off Corticosteroids (CS) [ Time Frame: At Week 24 and Week 52 ]
  14. PRR in participants who are able to completely taper off Corticosteroids (CS) [ Time Frame: At Week 24 and Week 52 ]
  15. Incidence of renal systemic lupus erythematosus (SLE) flare [ Time Frame: Up to Week 52 ]
  16. Change from Baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) [ Time Frame: At Week 24 and Week 52 ]
  17. Change form baseline in 36-item Short Form Health Questionnaire (SF-36) [ Time Frame: At Week 24 and Week 52 ]


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 Erythematosus International Collaborating Clinics (SLICC) criteria for SLE
  • Renal biopsy confirming a histologic diagnosis of active LN: International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III (A or A/C), IV-S (A or A/C), or IV-G (A or A/C); or Class V (in combination with Class III or IV)
  • Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg

Exclusion Criteria:

  • Pure ISN/RPS Class V membranous LN
  • Screening estimated glomerular filtration rate (eGFR; calculated using the Modification of Diet in Renal Disease [MDRD] equation) ≤30 mL/min/1.73 m2
  • Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study

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): NCT03943147


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 #.

Locations
Hide Hide 152 study locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Emmy Bell, Site 0100         
United States, California
The Nephrology Group Recruiting
Fresno, California, United States, 93720
Contact: Hemant Dhingra, Site 0060         
The Regents of The University of California Recruiting
Los Angeles, California, United States, 90095
Contact: Maureen McMahon, Site 0069         
United States, Colorado
Local Institution Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Site 0109         
United States, Connecticut
Local Institution Not yet recruiting
New Haven, Connecticut, United States, 06520
Contact: Site 0125         
United States, Florida
University of Florida Health Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Michael Bubb, Site 0029         
United States, Georgia
Local Institution Not yet recruiting
Atlanta, Georgia, United States, 30303
Contact: Site 0122         
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Laura Mulloy, Site 0107         
Atlanta Nephrology Referral Center Recruiting
Lawrenceville, Georgia, United States, 30046
Contact: William Paxton, Site 0128         
United States, Illinois
Northwestern Medical Faculty Foundation Recruiting
Chicago, Illinois, United States, 60611-5966
Contact: Shikha Wadhwani, Site 0059         
The University of Chicago Medicine Recruiting
Chicago, Illinois, United States, 60637
Contact: Kimberly Trotter, Site 0052         
Local Institution Withdrawn
Hinsdale, Illinois, United States, 60521
United States, Indiana
Nephrology Associates of Northern Illinois and Indiana - Fort Wayne Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Andrew OShaughnessy, Site 0098         
United States, Louisiana
Local Institution Not yet recruiting
New Orleans, Louisiana, United States, 70121
Contact: Site 0137         
United States, Maryland
Local Institution Not yet recruiting
Baltimore, Maryland, United States, 21205
Contact: Site 0131         
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02118
Contact: Site 0097         
Renal and Transplant Associates of New England, PC Recruiting
Springfield, Massachusetts, United States, 01107
Contact: Michael Germain, Site 0086         
Local Institution Withdrawn
Worcester, Massachusetts, United States, 01605
United States, Michigan
Brighton Center for Specialty Care Recruiting
Brighton, Michigan, United States, 48116
Contact: Patricia Cagnoli, Site 0067         
Local Institution Withdrawn
Detroit, Michigan, United States, 48202
United States, Missouri
Clinical Research Consultants - Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Ahmed Awad, Site 0080         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Tingting Li, Site 0072         
United States, New Jersey
Rutgers New Jersey Medical School Recruiting
Newark, New Jersey, United States, 07103
Contact: Joshua Kaplan, Site 0002         
Institute for Rheumatic and Autoimmune Diseases Recruiting
Summit, New Jersey, United States, 07901
Contact: Neil Kramer, Site 0081         
United States, New York
NewYork-Presbyterian Queens Recruiting
Fresh Meadows, New York, United States, 11365
Contact: Ritesh Raichoudhury, Site 0020         
Northwell Health Physician Partners at Great Neck Recruiting
Great Neck, New York, United States, 11021
Contact: Richard Furie, Site 0017         
Local Institution Not yet recruiting
Manhasset, New York, United States, 11030
Contact: Site 0129         
NYU Langone Orthopedic Center Recruiting
New York, New York, United States, 10016
Contact: Amit Saxena, Site 0039    646-501-7391      
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Miriam Chung, Site 0103         
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Laura Geraldino-Pardilla, Site 0108         
State University of New York Upstate Medical University Recruiting
Syracuse, New York, United States, 13210-2342
Contact: Andras Perl, Site 0008         
United States, North Carolina
East Carolina University Physicians Recruiting
Greenville, North Carolina, United States, 27834
Contact: Reginald Obi, Site 0027         
United States, Ohio
Local Institution Withdrawn
Cleveland, Ohio, United States, 44109
Ohio State University, Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Samir Parikh, Site 0023         
United States, Oklahoma
Oklahoma Medical Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Cristina Arriens, Site 0066         
United States, Pennsylvania
Northeast Clinical Research Center Recruiting
Bethlehem, Pennsylvania, United States, 18017
Contact: Nelson Kopyt, Site 0005    16104334100430      
Local Institution Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Site 0119         
Local Institution Withdrawn
Philadelphia, Pennsylvania, United States, 19104
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site 0127         
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Site 0138         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Matthew Lynch, Site 0042         
United States, South Carolina
Medical University of South Carolina - West Ashley Medical Pavilion Recruiting
Charleston, South Carolina, United States, 29425
Contact: James Oates, Site 0030         
United States, Tennessee
Office of Ramesh C. Gupta, MD Recruiting
Memphis, Tennessee, United States, 38119
Contact: Ramesh Gupta, Site 0001         
United States, Texas
Nephrotex Research Group Recruiting
Dallas, Texas, United States, 75231
Contact: Sumit Kumar, Site 0105    214-783-3953      
Dallas Nephrology Associates - North Office Recruiting
Dallas, Texas, United States, 75240
Contact: Tapan Patel, Site 0099    214-366-6125      
El Paso Medical Research Institute Recruiting
El Paso, Texas, United States, 79935
Contact: German Hernandez, Site 0016    859-421-4953      
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Dia Rose Waguespack, Site 0104    713-500-6868      
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Josephine Abraham, Site 0031         
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98101
Contact: Site 0117         
Local Institution Not yet recruiting
Seattle, Washington, United States, 98195-6340
Contact: Site 0118         
Argentina
Local Institution Not yet recruiting
Ciudad Aut? De Buenos Aires, Buenos Aires, Argentina, C1111AAL
Contact: Site 0134         
Local Institution Not yet recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1012AAR
Contact: Site 0141         
Local Institution Not yet recruiting
Junin, Buenos Aires, Argentina, 6000
Contact: Site 0152         
Local Institution Not yet recruiting
La Plata, Buenos Aires, Argentina, B1904CFU
Contact: Site 0132         
Local Institution Not yet recruiting
Rosario, Santa FE, Argentina, 2000
Contact: Site 0136         
Local Institution Not yet recruiting
Buenos Aires, Argentina, C1426ABP
Contact: Site 0144         
Local Institution Withdrawn
Cordoba, Argentina, X5004FHP
Local Institution Not yet recruiting
Salta, Argentina, A4400AXO
Contact: Site 0135         
Local Institution Not yet recruiting
San Juan, Argentina, 5402
Contact: Site 0133         
Australia, New South Wales
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 1871
Contact: Michael Suranyi, Site 0096    +61287383713      
Australia, Queensland
Local Institution Withdrawn
Woollongabba, Queensland, Australia, 4102
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Aron Chakera, Site 0046    +61864576910      
Belgium
Universitair Ziekenhuis Leuven Recruiting
Leuven, Belgium, 3000
Contact: Ben Sprangers, Site 0032         
Centre Hospitalier Universitaire de Liege Site Sart Tilman Recruiting
Liege, Belgium, 4000
Contact: Michel Malaise, Site 0074         
Brazil
Local Institution Not yet recruiting
Salvador, Bahia, Brazil, 40150-150
Contact: Site 0146         
Local Institution Not yet recruiting
Goi?, Goias, Brazil, 74110-120
Contact: Site 0148         
Local Institution Not yet recruiting
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Contact: Site 0140         
Local Institution Not yet recruiting
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Contact: Site 0147         
Local Institution Not yet recruiting
Uberlandia, Minas Gerais, Brazil, 38402-144
Contact: Site 0139         
Local Institution Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90020
Contact: Site 0143         
Local Institution Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
Contact: Site 0150         
Local Institution Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
Contact: Site 0149         
Local Institution Not yet recruiting
S?aulo, SAO Paulo, Brazil, 04032-060
Contact: Site 0151         
Local Institution Not yet recruiting
S?aulo, SAO Paulo, Brazil, 05403-000
Contact: Site 0142         
Canada, Alberta
Local Institution Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Site 0079         
Local Institution Withdrawn
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5T 3A9
Contact: Site 0073         
Canada, Quebec
Local Institution Withdrawn
Greenfield Park, Quebec, Canada, J4V 2H1
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H2X 0A9
Contact: Site 0153         
Canada
Local Institution Not yet recruiting
Quebec, Canada, G1V 4G2
Contact: Site 0130         
Chile
Local Institution Withdrawn
Temuco, Araucania, Chile
Local Institution Withdrawn
Providencia, Metropolitana, Chile
Local Institution Withdrawn
Recoleta, Metropolitana, Chile, 8431657
China, Beijing
Local Institution Not yet recruiting
Beijing, Beijing, China, 100044
Contact: Site 0154         
China, Guangdong
Local Institution Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Site 0121         
China, Jiangsu
Local Institution Not yet recruiting
Jiangsu, Jiangsu, China, 214023
Contact: Site 0155         
Local Institution Not yet recruiting
Nanjing Shi, Jiangsu, China, 210009
Contact: Site 0102         
China, Shan3xi
Local Institution Not yet recruiting
Xian, Shan3xi, China, 710061
Contact: Site 0101         
China, Shanghai
Local Institution Withdrawn
Shanghai, Shanghai, China, 200001
Local Institution Withdrawn
Shanghai, Shanghai, China, 200040
Czechia
Revmatologicky Ustav Recruiting
Praha 2, Czechia, 12850
Contact: Jakub Zavada, Site 0026         
Vseobecna Fakultni Nemocnice v Praze Recruiting
Praha, Czechia, 128 08
Contact: Vladimir Tesar, Site 0044         
Germany
Universitaetsklinikum Essen Recruiting
Essen, Germany, 45147
Contact: Sebastian Dolff, Site 0041    +492017232552      
Local Institution Withdrawn
Frankfurt Am Main, Germany, 60590
Local Institution Not yet recruiting
Hannover, Germany, 30625
Contact: Site 0022         
Universitatsmedizin der Johannes Gutenberg Universitat Mainz Recruiting
Mainz, Germany, 55131
Contact: Andreas Schwarting, Site 0018    +4906131176252      
Hong Kong
Local Institution Withdrawn
Hong Kong, Hong Kong, 8525
Israel
Local Institution Recruiting
Haifa, Israel, 3339419
Contact: Site 0065         
Local Institution Recruiting
Kfar Saba, Israel, 4428164
Contact: Site 0078         
Local Institution Recruiting
Tel Aviv, Israel, 6423906
Contact: Site 0076         
Italy
Local Institution Not yet recruiting
Milano, Italy, 20132
Contact: Site 0082         
Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco Recruiting
Milan, Italy, 20157
Contact: Maurizio Gallieni, Site 0077    +390239042525      
Universita degli Studi di Napoli Federico II Recruiting
Napo, Italy, 80131
Contact: Antonio Pisani, Site 0062    +393332902303      
Local Institution Not yet recruiting
Padova, Italy, 35128
Contact: Site 0116         
Istituto Scientifico di Pavia Recruiting
Pavia, Italy, 27100
Contact: Ciro Esposito, Site 0057    +390382592969      
Korea, Republic of
Local Institution Recruiting
Busan, Korea, Republic of, 602-715
Contact: Site 0003         
Local Institution Recruiting
Daejeon, Korea, Republic of, 35015
Contact: Site 0071         
Local Institution Recruiting
Gwangju, Korea, Republic of, 61469
Contact: Site 0090         
Local Institution Recruiting
Seoul, Korea, Republic of, 05030
Contact: Site 0061         
Local Institution Recruiting
Seoul, Korea, Republic of, 05505
Contact: Site 0040         
Local Institution Recruiting
Seoul, Korea, Republic of, 110-774
Contact: Site 0056         
Local Institution Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Site 0007         
Local Institution Recruiting
Suwon, Korea, Republic of, 442-723
Contact: Site 0070         
Mexico
Local Institution Not yet recruiting
Ciudad de Mexico, Distrito Federal, Mexico, 06090
Contact: Site 0120         
Local Institution Not yet recruiting
Ciudad de Mexico, Distrito Federal, Mexico, 14080
Contact: Site 0126         
Local Institution Not yet recruiting
Mexico, Distrito Federal, Mexico, 11850
Contact: Site 0094         
Local Institution Not yet recruiting
Leon, Guanajuato, Mexico, 37000
Contact: Site 0093         
Local Institution Not yet recruiting
Guadalajara, Jalisco, Mexico, 44160
Contact: Site 0095         
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Recruiting
Zapopan, Jalisco, Mexico, 45030
Contact: Adriana Sanchez Ortiz, Site 0092    +523315220008      
Local Institution Not yet recruiting
Chihuahua, Mexico, 31217
Contact: Site 0115         
Local Institution Not yet recruiting
San Luis Potosi, Mexico, 78200
Contact: Site 0113         
Local Institution Not yet recruiting
San Luis Potosi, Mexico, 78240
Contact: Site 0114         
Netherlands
Local Institution Withdrawn
Groningen, Netherlands, 9728 NT
Maastricht University Medical Centre Recruiting
Maastricht, Netherlands, 6229 HX
Contact: Pieter Van Paassen, Site 0010         
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Paul Van Daele, Site 0036         
Local Institution Withdrawn
Utrecht, Netherlands, 3584 CX
Poland
Local Institution Withdrawn
Szczecin, Poland, 71-252
Russian Federation
Medical Center Recruiting
Kemerovo, Russian Federation, 650070
Contact: Svetlana Polyakova, Site 0009    +79133048735      
City Clinical Hospital #15 named after O.M. Filatova Recruiting
Moscow, Russian Federation, 111539
Contact: Ivan Gordeev, Site 0011         
V.A. Nasonova Research Rheumatology Institute Recruiting
Moscow, Russian Federation, 115522
Contact: Aleksander Lila, Site 0038    +79683996686      
Local Institution Withdrawn
Saint Petersburg, Russian Federation, 194156
Saratov Regional Clinical Hospital Recruiting
Saratov, Russian Federation, 410053
Contact: Olga Reshetko, Site 0015    +78452491467      
Spain
Fundacio Puigvert Recruiting
Barcelona, Spain, 08025
Contact: Montserrat Diaz Encarnacion, Site 0014    +34934169700      
Hospital Universitari Vall dHebron Recruiting
Barcelona, Spain, 08035
Contact: Josefina Cortes Hernandez, Site 0004    +34934894045      
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Gerard Espinosa, Site 0006    +34932275774      
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
Contact: Patricia Carreira Delgado, Site 0088    +34917792851      
Hospital Regional Universitario de Malaga Hospital General Recruiting
Malaga, Spain, 29010
Contact: Antonio Fernandez-Nebro, Site 0048    +34951290206      
Hospital Universitario Nuestra Senora de Valme Recruiting
Sevilla, Spain, 41014
Contact: Jose Luis Marenco, Site 0045    +34955015760      
Local Institution Withdrawn
Valencia, Spain, 46010
Sweden
Local Institution Not yet recruiting
Linkoping, Sweden, 581 85
Contact: Site 0019         
Taiwan
Local Institution Recruiting
Hualien, Taiwan, 97002
Contact: Site 0050         
Local Institution Recruiting
Kaohsiung City, Taiwan, 833
Contact: Site 0055         
Local Institution Recruiting
Taichung, Taiwan, 40705
Contact: Site 0035         
Local Institution Recruiting
Tainan, Taiwan, 71004
Contact: Site 0037         
Local Institution Recruiting
Taipei, Taiwan, 112
Contact: Site 0043         
United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Contact: Rachel Jones, Site 0058    +4401223216534      
Local Institution Withdrawn
Aberdeen, United Kingdom, AB25 2ZN
Brighton and Sussex University Hospitals NHS Trust Recruiting
Brighton, United Kingdom, BN2 5BE
Contact: Sarah Lawman, Site 0063    +012736969557728      
University Hospitals of Leicester NHS Trust Recruiting
Leicester, United Kingdom, LE5 4PW
Contact: Peter Topham, Site 0013    +4401162588013      
Barts Health NHS Trust Recruiting
London, United Kingdom, E1 1BB
Contact: Andrea Cove-Smith, Site 0028    +4402035941684      
Manchester University NHS Foundation Trust Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Benjamin Parker, Site 0033    +4401612764357      
Epsom and Saint Helier University Hospitals NHS Trust Recruiting
Surrey, United Kingdom, SM5 1AA
Contact: Bhrigu Sood, Site 0051         
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: NCT03943147    
Other Study ID Numbers: IM011-073
2018-004142-42 ( EudraCT Number )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 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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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
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