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

Primary Purpose

Lupus Nephritis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986165
Placebo
Mycophenolate Mofetil
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Systemic Lupus Erythematosus (SLE)
  • Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN) International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III, IV-S, or IV-G; or Class V
  • Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg or UPCR ≥1 mg/mg assessed with a 24-hour urine specimen

Exclusion Criteria:

  • Pure ISN/RPS Class V membranous LN
  • Screening estimated glomerular filtration rate ≤30 mL/min/1.73 m^2
  • Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study
  • End-stage renal disease

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • University of Alabama at Birmingham
  • The Nephrology Group
  • The Regents of The University of California
  • University of Colorado School of Medicine
  • Local Institution - 0029
  • Emory University
  • Augusta University
  • Atlanta Nephrology Referral Center
  • Northwestern Medical Faculty Foundation
  • The University of Chicago Medicine
  • Nephrology Associates of Northern Illinois and Indiana - Fort Wayne
  • Johns Hopkins University, Office of Research Administration
  • Renal and Transplant Associates of New England, PC
  • Brighton Center for Specialty Care
  • Clinical Research Consultants - Kansas City
  • Washington University School of Medicine
  • Rutgers New Jersey Medical School
  • Institute for Rheumatic and Autoimmune Diseases
  • NewYork-Presbyterian Queens
  • Northwell Health Physician Partners at Great Neck
  • Local Institution - 0039
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Medical Center
  • State University of New York Upstate Medical University
  • East Carolina University Physicians
  • Ohio State University, Wexner Medical Center
  • Local Institution - 0066
  • Northeast Clinical Research Center
  • University of Pennsylvania
  • Temple University Hospital
  • Rhode Island Hospital
  • Local Institution - 0030
  • Office of Ramesh C. Gupta, MD
  • Nephrotex Research Group
  • Dallas Nephrology Associates - North Office
  • El Paso Medical Research Institute
  • The University of Texas Health Science Center at Houston
  • University of Utah
  • Virginia Mason Medical Center
  • University of Washington School of Medicine
  • Liverpool Hospital
  • Sir Charles Gairdner Hospital
  • Universitair Ziekenhuis Leuven
  • Centre Hospitalier Universitaire de Liege Site Sart Tilman
  • Sheldon M. Chumir Health Center
  • Toronto Western Hospital
  • Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval
  • Local Institution
  • Local Institution
  • Revmatologicky Ustav
  • Vseobecna Fakultni Nemocnice v Praze
  • Universitaetsklinikum Essen
  • Medizinische Hochschule Hannover
  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0082
  • Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco
  • Universita degli Studi di Napoli Federico II
  • Istituto Scientifico di Pavia
  • Local Institution
  • Local Institution - 0071
  • Local Institution - 0090
  • Local Institution - 0056
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Unidad de Investigacion de las Enfermedades Reumaticas
  • Local Institution - 0094
  • Morales Vargas Centro de Investigacion
  • Centro Integral de Reumatologia
  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
  • Servicios Hospitalarios de Mexico
  • Centro de Atencion e Investigacion Cardiovascular del Potosi
  • Hospital Central Doctor Ignacio Morones Prieto
  • Maastricht University Medical Centre
  • Erasmus Medisch Centrum
  • Medical Center
  • City Clinical Hospital #15 named after O.M. Filatova
  • V.A. Nasonova Research Rheumatology Institute
  • Local Institution - 0015
  • Fundacio Puigvert
  • Hospital Universitari Vall dHebron
  • Hospital Clinic de Barcelona
  • Hospital Universitario 12 de Octubre
  • Hospital Regional Universitario de Malaga Hospital General
  • Hospital Universitario Nuestra Senora de Valme
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0037
  • Local Institution
  • Brighton and Sussex University Hospitals NHS Trust
  • Cambridge University Hospitals NHS Foundation Trust
  • University Hospitals of Leicester NHS Trust
  • Barts Health NHS Trust
  • Manchester University NHS Foundation Trust
  • Epsom and Saint Helier University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Arm Label

BMS-986165 Dose 1

BMS-986165 Dose 2

Placebo for BMS-986165

Mycophenolate Mofetil (MMF)

Arm Description

Specified Dose on Specified Days

Specified Dose on Specified Days

Specified Dose on Specified Days

Specified Dose on Specified Days

Outcomes

Primary Outcome Measures

The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)
The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)
The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B)
The percent change from baseline in UPCR based on 24-hour urine collections. 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.

Secondary Outcome Measures

The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)
The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)
The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 52.
The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 24 in the Blinded Treatment Period (Part B)
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 52 in the Blinded Treatment Period (Part B)
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.

Full Information

First Posted
April 29, 2019
Last Updated
September 16, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03943147
Brief Title
An Investigational Study to Evaluate the Safety and Effectiveness of BMS-986165 With Background Treatment in Participants With Lupus Nephritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
October 29, 2020 (Actual)
Study Completion Date
September 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind Study
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986165 Dose 1
Arm Type
Experimental
Arm Description
Specified Dose on Specified Days
Arm Title
BMS-986165 Dose 2
Arm Type
Experimental
Arm Description
Specified Dose on Specified Days
Arm Title
Placebo for BMS-986165
Arm Type
Placebo Comparator
Arm Description
Specified Dose on Specified Days
Arm Title
Mycophenolate Mofetil (MMF)
Arm Type
Experimental
Arm Description
Specified Dose on Specified Days
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Mycophenolate Mofetil
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
The Number of Participants Experiencing Averse Events in the Blinded Treatment Period (Part B)
Description
An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Time Frame
From baseline up to 52 weeks after first dose in Part B
Title
The Number of Participants With Clinically Significant ECG Abnormalities in the Blinded Treatment Period (Part B)
Description
The number of participants with clinically significant abnormalities in electrocardiograms (ECGs) parameters. The following ECG parameters will be measured: HR, PR-interval, QRS-duration, QT-interval, QTc-interval. A single 12-lead ECG will be recorded after the participant has been supine for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Time Frame
From baseline up to 52 weeks after first dose in Part B
Title
The Percent Change in Vital Sign Measurements in the Blinded Treatment Period (Part B)
Description
The percent change from baseline in Vital sign measurements including: blood pressure, heart rate, respiratory rate, and temperature. Blood pressure and heart rate are measured after the participant has been resting quietly for at least 5 minutes. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Time Frame
From baseline up to 52 weeks after first dose in Part B
Title
The Number of Participants With Abnormal Laboratory Parameters of Clinical Significance in the Blinded Treatment Period (Part B)
Description
The number of participants with abnormal laboratory parameters (Chemistry, hematology, coagulation, immunohematology) that have been considered clinically significant. Clinically relevant laboratory results are determined by the investigator. Data collected from the week 12 visit in Part A will be used for baseline values in Part B.
Time Frame
From baseline up to 52 weeks after first dose in Part B
Title
Percent Change From Baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR) at Week 24 in the Blinded Treatment Period (Part B)
Description
The percent change from baseline in UPCR based on 24-hour urine collections. 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
The Number of Participants With Partial Renal Response (PRR) at Week 24 in the Blinded Treatment Period (Part B)
Description
The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 24.
Time Frame
Week 24
Title
The Number of Participants With Partial Renal Response (PRR) at Week 52 in the Blinded Treatment Period (Part B)
Description
The number of participants with partial renal response (PRR) defined as ≥ 50% reduction from baseline in 24-hour Urine Protein:Creatinine Ratio (UPCR). 24-hour urine specimens measure the levels of proteins and creatinine in urine and will be used for the UPCR at baseline (week 12) and week 52.
Time Frame
Week 52
Title
The Number of Participants With Complete Renal Response (CRR) at Week 24 in the Blinded Treatment Period (Part B)
Description
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
Time Frame
Week 24
Title
The Number of Participants With Complete Renal Response (CRR) at Week 52 in the Blinded Treatment Period (Part B)
Description
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline.
Time Frame
Week 52
Title
The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 24 in the Blinded Treatment Period (Part B)
Description
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
Time Frame
Week 24
Title
The Number of Participants With Complete Renal Response (CRR) Plus Successful Corticosteroid Taper to ≤ 7.5 mg/Day at Week 52 in the Blinded Treatment Period (Part B)
Description
The number of participants with complete renal response (CRR) defined as a 24-hour Urine Protein:Creatinine Ratio (UPCR) ≤ 0.5 mg/mg and an estimated glomerular filtration rate (eGFR) (using the MDRD equation) ≥ 60 mL/min or ≤ 20% decrease from baseline who was also able to successfully taper corticosteroid use to ≤ 7.5 mg/day.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 Systemic Lupus Erythematosus (SLE) Renal biopsy confirming a histologic diagnosis of active Lupus Nephritis (LN) International Scociety of Nephrology/Renal Pathology Society (ISN/RPS) Classes III, IV-S, or IV-G; or Class V Urine protein:creatinine ratio (UPCR) ≥1.5 mg/mg or UPCR ≥1 mg/mg assessed with a 24-hour urine specimen Exclusion Criteria: Pure ISN/RPS Class V membranous LN Screening estimated glomerular filtration rate ≤30 mL/min/1.73 m^2 Dialysis within 12 months before screening or plans for dialysis within 6 months after enrollment in the study End-stage renal disease Other protocol-defined inclusion/exclusion criteria apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
The Nephrology Group
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
The Regents of The University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Colorado School of Medicine
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0029
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32603
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Atlanta Nephrology Referral Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-5966
Country
United States
Facility Name
The University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Nephrology Associates of Northern Illinois and Indiana - Fort Wayne
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
Johns Hopkins University, Office of Research Administration
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Renal and Transplant Associates of New England, PC
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Brighton Center for Specialty Care
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48116
Country
United States
Facility Name
Clinical Research Consultants - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rutgers New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Institute for Rheumatic and Autoimmune Diseases
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
NewYork-Presbyterian Queens
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11365
Country
United States
Facility Name
Northwell Health Physician Partners at Great Neck
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Local Institution - 0039
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210-2342
Country
United States
Facility Name
East Carolina University Physicians
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Ohio State University, Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Local Institution - 0066
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Northeast Clinical Research Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Local Institution - 0030
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Office of Ramesh C. Gupta, MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Nephrotex Research Group
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Dallas Nephrology Associates - North Office
City
Dallas
State/Province
Texas
ZIP/Postal Code
75240
Country
United States
Facility Name
El Paso Medical Research Institute
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6340
Country
United States
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
1871
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liege Site Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Sheldon M. Chumir Health Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Local Institution
City
Xian
State/Province
Shan3xi
ZIP/Postal Code
710061
Country
China
Facility Name
Revmatologicky Ustav
City
Praha 2
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Vseobecna Fakultni Nemocnice v Praze
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Local Institution
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Local Institution
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Local Institution - 0082
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda SocioSanitaria Territoriale Fatebenefratelli Sacco
City
Milan
ZIP/Postal Code
20157
Country
Italy
Facility Name
Universita degli Studi di Napoli Federico II
City
Napo
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Scientifico di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Local Institution - 0071
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Local Institution - 0090
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Local Institution - 0056
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Suwon
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
Unidad de Investigacion de las Enfermedades Reumaticas
City
Ciudad de Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06090
Country
Mexico
Facility Name
Local Institution - 0094
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Morales Vargas Centro de Investigacion
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Centro Integral de Reumatologia
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45030
Country
Mexico
Facility Name
Servicios Hospitalarios de Mexico
City
Chihuahua
ZIP/Postal Code
31217
Country
Mexico
Facility Name
Centro de Atencion e Investigacion Cardiovascular del Potosi
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Hospital Central Doctor Ignacio Morones Prieto
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Maastricht University Medical Centre
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Medical Center
City
Kemerovo
ZIP/Postal Code
650070
Country
Russian Federation
Facility Name
City Clinical Hospital #15 named after O.M. Filatova
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
V.A. Nasonova Research Rheumatology Institute
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Local Institution - 0015
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Fundacio Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall dHebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga Hospital General
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Nuestra Senora de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Local Institution
City
Hualien
ZIP/Postal Code
97002
Country
Taiwan
Facility Name
Local Institution
City
Kaohsiung City
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Local Institution - 0037
City
Tainan
ZIP/Postal Code
71004
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Brighton and Sussex University Hospitals NHS Trust
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Epsom and Saint Helier University Hospitals NHS Trust
City
Surrey
ZIP/Postal Code
SM5 1AA
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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