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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 : July 15, 2019
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-986165 compared 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 : April 19, 2019
Estimated Primary Completion Date : July 7, 2021
Estimated Study Completion Date : July 7, 2021

Resource links provided by the National Library of Medicine


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

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

Placebo Comparator: Placebo oral administration 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 ]
  2. Complete renal response (CRR) [ Time Frame: At Week 52 ]
  3. CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 24 ]
  4. CRR + successful CS taper ≤7.5 mg/day [ Time Frame: At Week 52 ]
  5. Partial renal response (PRR) [ Time Frame: At Week 52 ]


Information from the National Library of Medicine

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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 #.

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Locations
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United States, Alabama
Local Institution Not yet recruiting
Birmingham, Alabama, United States, 35294-3300
Contact: Site 0100         
United States, California
The Nephrology Group Recruiting
Fresno, California, United States, 93720
Contact: Hemant Dhingra, Site 0060         
Local Institution Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Site 0069         
United States, Colorado
Local Institution Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Site 0109         
United States, Florida
Local Institution Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Site 0029         
United States, Georgia
Local Institution Not yet recruiting
Augusta, Georgia, United States, 30912
Contact: Site 0107         
United States, Illinois
Local Institution Not yet recruiting
Hinsdale, Illinois, United States, 60521
Contact: Site 0084         
United States, Indiana
Local Institution Not yet recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Site 0098         
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         
United States, Michigan
Local Institution Not yet recruiting
Brighton, Michigan, United States, 48116
Contact: Site 0067         
Local Institution Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Site 0075         
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
Local Institution Not yet recruiting
Newark, New Jersey, United States, 07103
Contact: Site 0002         
Local Institution Not yet recruiting
Summit, New Jersey, United States, 07901
Contact: Site 0081         
United States, New York
NewYork-Presbyterian Queens Recruiting
Fresh Meadows, New York, United States, 11365
Contact: Ritesh Raichoudhury, Site 0020         
Local Institution Not yet recruiting
Great Neck, New York, United States, 11021
Contact: Site 0017         
Local Institution Not yet recruiting
New York, New York, United States, 10016
Contact: Site 0039         
Local Institution Not yet recruiting
New York, New York, United States, 10029
Contact: Site 0103         
Local Institution Not yet recruiting
New York, New York, United States, 10032
Contact: Site 0108         
Local Institution Not yet recruiting
Syracuse, New York, United States, 13210-2342
Contact: Site 0008         
United States, Ohio
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         
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site 0068         
United States, Rhode Island
Local Institution Not yet recruiting
Providence, Rhode Island, United States, 02903
Contact: Site 0042         
United States, South Carolina
Local Institution Not yet recruiting
Charleston, South Carolina, United States, 29425
Contact: 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
Local Institution Not yet recruiting
Dallas, Texas, United States, 75231
Contact: Site 0105         
Local Institution Not yet recruiting
Dallas, Texas, United States, 75240
Contact: Site 0099         
El Paso Medical Research Institute Recruiting
El Paso, Texas, United States, 79935
Contact: German Hernandez, Site 0016    915-307-4669      
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 0104         
United States, Utah
Local Institution Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Site 0031         
Australia, New South Wales
Local Institution Not yet recruiting
Liverpool, New South Wales, Australia, 1871
Contact: Site 0096         
Australia, Queensland
Local Institution Not yet recruiting
Woollongabba, Queensland, Australia, 4102
Contact: Site 0091         
Australia, Western Australia
Local Institution Not yet recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 0046         
Belgium
Local Institution Not yet recruiting
Leuven, Belgium, 3000
Contact: Site 0032         
Local Institution Not yet recruiting
Liege, Belgium, 4000
Contact: Site 0074         
Canada, Alberta
Local Institution Not yet recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Site 0079         
Local Institution Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Site 0047         
Canada, Ontario
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5T 3A9
Contact: Site 0073         
Canada, Quebec
Local Institution Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contact: Site 0053         
Chile
Local Institution Not yet recruiting
Temuco, Araucania, Chile
Contact: Site 0112         
Local Institution Not yet recruiting
Providencia, Metropolitana, Chile
Contact: Site 0110         
Local Institution Not yet recruiting
Recoleta, Metropolitana, Chile, 8431657
Contact: Site 0111         
China, Jiangsu
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 Not yet recruiting
Shanghai, Shanghai, China, 200001
Contact: Site 0089         
Local Institution Not yet recruiting
Shanghai, Shanghai, China, 200040
Contact: Site 0083         
Czechia
Local Institution Not yet recruiting
Praha, Czechia, 128 08
Contact: Site 0044         
Germany
Local Institution Not yet recruiting
Essen, Germany, 45147
Contact: Site 0041         
Local Institution Not yet recruiting
Frankfurt Am Main, Germany, 60590
Contact: Site 0064         
Local Institution Not yet recruiting
Hannover, Germany, 30625
Contact: Site 0022         
Local Institution Not yet recruiting
Mainz, Germany, 55131
Contact: Site 0018         
Hong Kong
Local Institution Not yet recruiting
Hong Kong, Hong Kong, 8525
Contact: Site 0025         
Israel
Local Institution Not yet recruiting
Haifa, Israel, 3339419
Contact: Site 0065         
Local Institution Not yet recruiting
Kfar Saba, Israel, 4428164
Contact: Site 0078         
Local Institution Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Site 0076         
Italy
Local Institution Not yet recruiting
Milano, Italy, 20132
Contact: Site 0082         
Local Institution Not yet recruiting
Milan, Italy, 20157
Contact: Site 0077         
Local Institution Not yet recruiting
Napo, Italy, 80131
Contact: Site 0062         
Local Institution Not yet recruiting
Padova, Italy, 35128
Contact: Site 0116         
Local Institution Not yet recruiting
Pavia, Italy, 27100
Contact: Site 0057         
Korea, Republic of
Local Institution Not yet recruiting
Busan, Korea, Republic of, 602-715
Contact: Site 0003         
Local Institution Not yet recruiting
Daejeon, Korea, Republic of, 35015
Contact: Site 0071         
Local Institution Not yet recruiting
Gwangju, Korea, Republic of, 61469
Contact: Site 0090         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 05505
Contact: Site 0040         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 110-774
Contact: Site 0056         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 137-701
Contact: Site 0007         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 143-729
Contact: Site 0061         
Local Institution Not yet recruiting
Suwon, Korea, Republic of, 442-723
Contact: Site 0070         
Mexico
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         
Local Institution Not yet recruiting
Zapopan, Jalisco, Mexico, 45030
Contact: Site 0092         
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 Not yet recruiting
Groningen, Netherlands, 9728 NT
Contact: Site 0024         
Local Institution Not yet recruiting
Maastricht, Netherlands, 6229 HX
Contact: Site 0010         
Local Institution Not yet recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Site 0036         
Local Institution Not yet recruiting
Utrecht, Netherlands, 3584 CX
Contact: Site 0085         
Poland
Local Institution Not yet recruiting
Szczecin, Poland, 71-252
Contact: Site 0021         
Russian Federation
Local Institution Not yet recruiting
Kemerovo, Russian Federation, 650070
Contact: Site 0009         
Local Institution Not yet recruiting
Moscow, Russian Federation, 111539
Contact: Site 0011         
Local Institution Not yet recruiting
Moscow, Russian Federation, 115522
Contact: Site 0038         
Local Institution Not yet recruiting
Saratov, Russian Federation, 410053
Contact: Site 0015         
Spain
Local Institution Not yet recruiting
Barcelona, Spain, 08025
Contact: Site 0014         
Local Institution Not yet recruiting
Barcelona, Spain, 08035
Contact: Site 0004         
Local Institution Not yet recruiting
Barcelona, Spain, 08036
Contact: Site 0006         
Local Institution Not yet recruiting
Madrid, Spain, 28041
Contact: Site 0088         
Local Institution Not yet recruiting
Malaga, Spain, 29010
Contact: Site 0048         
Local Institution Not yet recruiting
Sevilla, Spain, 41014
Contact: Site 0045         
Local Institution Not yet recruiting
Valencia, Spain, 46010
Contact: Site 0049         
Sweden
Local Institution Not yet recruiting
Linkoping, Sweden, 581 85
Contact: Site 0019         
Taiwan
Local Institution Not yet recruiting
Hualien, Taiwan, 97002
Contact: Site 0050         
Local Institution Not yet recruiting
Kaohsiung City, Taiwan, 833
Contact: Site 0055         
Local Institution Not yet recruiting
Taichung, Taiwan, 40705
Contact: Site 0035         
Local Institution Not yet recruiting
Tainan, Taiwan, 71004
Contact: Site 0037         
Local Institution Not yet recruiting
Taipei, Taiwan, 112
Contact: Site 0043         
United Kingdom
Local Institution Not yet recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Contact: Site 0058         
Local Institution Not yet recruiting
Aberdeen, United Kingdom, AB25 2ZN
Contact: Site 0012         
Local Institution Not yet recruiting
Brighton, United Kingdom, BN2 5BE
Contact: Site 0063         
Local Institution Not yet recruiting
Leicester, United Kingdom, LE5 4PW
Contact: Site 0013         
Local Institution Not yet recruiting
London, United Kingdom, E1 1BB
Contact: Site 0028         
Local Institution Not yet recruiting
Manchester, United Kingdom, M13 9WL
Contact: Site 0033         
Local Institution Not yet recruiting
Surrey, United Kingdom, SM5 1AA
Contact: 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     History of Changes
Other Study ID Numbers: IM011-073
2018-004142-42 ( EudraCT Number )
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 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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Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases