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An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

Primary Purpose

Systemic Lupus Erythematosus

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

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus

Eligibility Criteria

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

Inclusion Criteria:

  • Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening visit
  • Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
  • One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory
  • Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash [score must be confirmed by Central Review Services (CRS)]
  • Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

  • 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 electrocardiogram (ECG)
  • History of any significant drug allergy

Other protocol defined inclusion/exclusion criteria apply

Sites / Locations

  • Local Institution - 0178
  • Little Rock Diagnostic Clinic
  • Local Institution - 0023
  • BioSolutions Clinical Research Center
  • Los Angeles County Hospital and University of Southern California Medical Center
  • University of California at Irvine College of Medicine
  • Local Institution - 0227
  • Millennium Clinical Trials - Thousand Oaks
  • The Lundquist Institute at Harbor-UCLA Medical Center
  • Inland Rheumatology Clinical Trials
  • Local Institution - 0034
  • Local Institution - 0195
  • Local Institution - 0010
  • Local Institution - 0066
  • Local Institution - 0214
  • Local Institution - 0233
  • Local Institution - 0057
  • Local Institution - 0002
  • Local Institution - 0038
  • BayCare Medical Group
  • Local Institution - 0206
  • Local Institution - 0022
  • Local Institution - 0083
  • Arthritis Research and Treatment Center
  • Klein & Associates
  • Klein and Associates
  • Advanced Rheumatology - Lansing
  • University of Minnesota
  • University of Mississippi Medical Center
  • Local Institution - 0011
  • SUNY Downstate Health Science University
  • Local Institution - 0082
  • Local Institution - 0109
  • Local Institution - 0232
  • Local Institution - 0119
  • Local Institution - 0026
  • Local Institution - 0180
  • Local Institution - 0197
  • University of Pittsburgh Medical Center
  • Local Institution - 0174
  • Local Institution - 0190
  • Local Institution - 0001
  • University of Tennessee Health Science Center
  • Local Institution - 0087
  • Local Institution - 0086
  • Pioneer Research Solutions
  • Baylor Research Institute
  • Local Institution - 0193
  • Local Institution - 0204
  • Local Institution - 0061
  • Local Institution - 0047
  • Arthritis and Osteoporosis Center of South Texas
  • Local Institution - 0171
  • University of Washington
  • Arthritis Northwest, PLLC
  • Local Institution - 0166
  • Local Institution - 0139
  • Local Institution - 0185
  • Local Institution - 0136
  • Local Institution - 0138
  • Local Institution - 0152
  • Local Institution - 0097
  • Local Institution - 0096
  • Hospital Privado Centro Medico de Cordoba
  • Local Institution - 0137
  • Local Institution - 0241
  • Heidelberg Repatriation Hospital
  • Local Institution - 0130
  • Local Institution - 0129
  • Santa Casa de Misericordia de Belo Horizonte
  • Local Institution - 0125
  • Local Institution - 0126
  • Local Institution - 0128
  • Hospital de Clinicas de Porto Alegre
  • Local Institution - 0151
  • CITIPA - Centro de Imunoterapia de Ipanema
  • Local Institution - 0148
  • Local Institution - 0247
  • University of Alberta Hospital
  • McMaster University Medical Centre
  • Local Institution - 0245
  • Local Institution - 0098
  • Local Institution - 0099
  • Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)
  • Medicity SAS
  • Local Institution - 0161
  • Local Institution - 0100
  • Local Institution - 0159
  • Allergie-Centrum-Charite Campus Charite Mitte Klinik fur Dermatologie Venerologie und Allergologi
  • Klinik fur Nieren- und Hochdruckerkrankungen
  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz - I. Medizinische Klinik und Poliklin
  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
  • Debreceni Egyetem Klinikai Kozpont
  • Local Institution - 0035
  • Local Institution - 0123
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0117
  • Kameda Clinic
  • Local Institution - 0177
  • Local Institution - 0141
  • Hokkaido University Hospital
  • Tohoku University Hospital
  • Tomishiro Central Hospital
  • Dokkyo Medical University
  • Local Institution - 0183
  • Local Institution - 0154
  • Local Institution - 0144
  • Keio University Hospital
  • Kanazawa University Hospital
  • Local Institution - 0162
  • Showa University Hospital
  • National Hospital Organization Tokyo Medical Center
  • Local Institution - 0133
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0253
  • Local Institution
  • Local Institution - 0054
  • Local Institution - 0050
  • Local Institution - 0140
  • Local Institution - 0173
  • Local Institution - 0163
  • Local Institution - 0172
  • Local Institution - 0135
  • Local Institution - 0156
  • Juan Alberto Rodriguez Ruiz
  • Local Institution - 0134
  • Local Institution - 0149
  • Faicic S. de R.L. de C.V.
  • Local Institution - 0089
  • Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C
  • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
  • Centrum Medyczne Pratia w Gdyni
  • Silmedic Sp. z o.o.
  • Zespol Opieki Zdrowotnej w Konskich
  • Local Institution - 0182
  • Local Institution - 0211
  • Local Institution - 0222
  • Centrum Medyczne ProMiMed
  • REUMED Sp. z o.o.
  • Medyczne Centrum Hetmanska - Poznan
  • Solumed Centrum Medyczne
  • Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Med-Polonia
  • Local Institution - 0093
  • SANUS Szpital Specjalistyczny
  • Local Institution - 0219
  • Local Institution - 0192
  • Local Institution - 0090
  • Centrum Medyczne AMED Warszawa Targowek
  • Local Institution - 0077
  • Local Institution - 0184
  • Local Institution - 0025
  • Neomed Research
  • Centrul Medical Sana
  • Spitalul Sfanta Maria
  • Spitalul Clinic Dr. Ioan Cantacuzino
  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • Spitalul Clinic Judeߥan de Urgenߡ Sfantul Apostol Andrei
  • Spitalul Judetean de Urgenta Valcea
  • CjSC
  • Kemerovo State Medical University
  • Medical Center Maksimum Zdorovia
  • Local Institution - 0210
  • Local Institution - 0006
  • State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova
  • Local Institution - 0207
  • Clinical Rheumatological Hospital Number 25
  • Polyclinic of Private Security Personnel
  • Private Healthcare Institution Clinical Hospital
  • Local Institution - 0223
  • Tolyatti city clinical hospital ߵ
  • Biomed
  • Local Institution - 0208
  • State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2
  • Complejo Hospitalario Universitario A Coruna
  • Hospital Universitari Vall dHebron
  • Hospital Regional Universitario de Malaga Hospital General
  • Hospital de Merida
  • Corporacio Sanitaria Parc Tauli
  • Local Institution - 0228
  • Local Institution
  • Local Institution - 0114
  • Local Institution
  • Local Institution - 0088
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

BMS-986165 Dose 1 oral administration

BMS-986165 Dose 2 oral administration

BMS-986165 Dose 3 oral administration

Placebo oral administration

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
SRI(4) responder is defined as a patient whose disease course fulfills all of the following: A 4-point or greater reduction from baseline in SLEDAI-2K score No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity

Secondary Outcome Measures

Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48
SRI(4) responder is defined as a patient whose disease course fulfills all of the following: A 4-point or greater reduction from baseline in SLEDAI-2K score No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response
BICLA responder is defined as a patient whose disease course fulfills all of the following: Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score) No increase ≥ 10% in the Physician's Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment
Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)
LLDAS is defined as follows: SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity A current prednisolone (or equivalent) dose ≤ 7.5 mg daily Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents
Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10
Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia
Change From Baseline in the 40-Joint Count
Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of: Tender joint count (0 to 40) Swollen joint count (0 to 40) Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following: Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation > 3× Upper Limit of Normal (ULN) Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase) No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic
Number of Participants With Abnormalities in Vital Signs
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure
Number of Participants With Abnormalities in Electrocardiograms (ECGs)
Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval
BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)
Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)
Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels
Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32
Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.
Percent Change From Baseline in Complement Proteins C3 and C4 Levels
Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
Percent Change From Baseline in Complement (C3, C4) Levels at Week 32
Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels
Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32
Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status
Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following: A 4-point or greater reduction from baseline in SLEDAI-2K score No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity

Full Information

First Posted
August 15, 2017
Last Updated
November 28, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03252587
Brief Title
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
October 28, 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
This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
363 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-986165 Dose 1 oral administration
Arm Type
Experimental
Arm Title
BMS-986165 Dose 2 oral administration
Arm Type
Experimental
Arm Title
BMS-986165 Dose 3 oral administration
Arm Type
Experimental
Arm Title
Placebo oral administration
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
Description
SRI(4) responder is defined as a patient whose disease course fulfills all of the following: A 4-point or greater reduction from baseline in SLEDAI-2K score No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
Time Frame
At week 32
Secondary Outcome Measure Information:
Title
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48
Description
SRI(4) responder is defined as a patient whose disease course fulfills all of the following: A 4-point or greater reduction from baseline in SLEDAI-2K score No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
Time Frame
At week 48
Title
Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response
Description
BICLA responder is defined as a patient whose disease course fulfills all of the following: Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score) No increase ≥ 10% in the Physician's Global Assessment of Disease Activity on a 3-point visual analog scale from no disease activity to severe disease activity No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment
Time Frame
At week 48
Title
Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)
Description
LLDAS is defined as follows: SLEDAI-2K ≤ 4, with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis, fever) and no hemolytic anemia or gastrointestinal activity measured as maintaining a D (no disease activity but suggests the system had previously been affected) or E (no current or previous disease activity) score in BILAG Gastrointestinal Body System No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity A current prednisolone (or equivalent) dose ≤ 7.5 mg daily Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents
Time Frame
At Week 48
Title
Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10
Description
Number of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score (ranges from 0-70, where a higher score is associated with high disease activity). CLASI assesses by body surface area; points are given for presence of erythema, scale, hypertrophy, mucous membrane lesions, recent hair loss, and physician-observed alopecia
Time Frame
At week 48
Title
Change From Baseline in the 40-Joint Count
Description
Change from baseline in the following 40-joint count: phalangeal joints of the hand, second through fifth metacarpophalangeal joints of the hand, and individual metatarsophalangeal joints of the feet, Bilateral first metacarpophalangeal joints and shoulders. Each of 40 joints count is evaluated based upon the presence or absence of: Tender joint count (0 to 40) Swollen joint count (0 to 40) Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease.
Time Frame
Baseline and week 48
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Number of participants with any grade adverse events (AEs) and any grade serious adverse events (SAEs). An adverse event (AE) including SAEs is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants that do not necessarily have causal relationship with treatment
Time Frame
From first dose to 30 days post last dose (Up to 52 weeks)
Title
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Description
Number of participants with laboratory abnormalities in specific liver tests based on US conventional units. The potential drug-induced liver injury is defined by the presence of all of the following: Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation > 3× Upper Limit of Normal (ULN) Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase) No other immediately apparent possible causes of AST or AST elevation and hyperbilirubinemia, including, but not limited to, viral hepatitis, preexisting chronic or acute liver disease, or the administration of other drug(s) known to be hepatotoxic
Time Frame
From first dose to 30 days post last dose (Up to 52 weeks)
Title
Number of Participants With Abnormalities in Vital Signs
Description
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure
Time Frame
From first dose to 30 days post last dose (Up to 52 weeks)
Title
Number of Participants With Abnormalities in Electrocardiograms (ECGs)
Description
Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval
Time Frame
From baseline to up to week 48
Title
BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)
Description
Maximum observed plasma concentration (Cmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Time Frame
Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12
Title
BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)
Description
Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.
Time Frame
Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12
Title
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)
Description
Trough observed plasma concentration (Ctrough) for the following treatments: BMS-986165 and its active metabolite BMT-153261. Geometric coefficient of variation was not calculated and the arithmetic coefficient of variation (% CV) is being reported.
Time Frame
Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48
Title
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels
Description
Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.
Time Frame
From baseline to week 44
Title
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32
Description
Percent change from baseline in interferon-regulated gene (IRG) expression levels. IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. Baseline values are defined as the last measurement before the first dose.
Time Frame
From baseline to week 32
Title
Percent Change From Baseline in Complement Proteins C3 and C4 Levels
Description
Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
Time Frame
From baseline to week 52
Title
Percent Change From Baseline in Complement (C3, C4) Levels at Week 32
Description
Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
Time Frame
From baseline to week 32
Title
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels
Description
Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
Time Frame
From baseline to week 52
Title
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32
Description
Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
Time Frame
From baseline to week 32
Title
Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status
Description
Global systemic lupus erythematosus (SLE) clinical response in participants based on interferon-regulated gene (IRG) status (high versus low IRG signature). IRG-high vs. IRG-low was determined using a 5-interferon (IFN) gene set during the sample collected at screening period. SRI(4) responder is defined as a patient whose disease course fulfills all of the following: A 4-point or greater reduction from baseline in SLEDAI-2K score No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) or not more than 1 new BILAG B (moderate disease activity) organ domain grade No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity
Time Frame
At week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening visit Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash [score must be confirmed by Central Review Services (CRS)] Men and women must agree to follow specific methods of contraception, if applicable Exclusion Criteria: 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 electrocardiogram (ECG) History of any significant drug allergy 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
Local Institution - 0178
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Little Rock Diagnostic Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Local Institution - 0023
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
BioSolutions Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Los Angeles County Hospital and University of Southern California Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California at Irvine College of Medicine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Local Institution - 0227
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Millennium Clinical Trials - Thousand Oaks
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
The Lundquist Institute at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Inland Rheumatology Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Local Institution - 0034
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-5353
Country
United States
Facility Name
Local Institution - 0195
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8018
Country
United States
Facility Name
Local Institution - 0010
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Local Institution - 0066
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Local Institution - 0214
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32603
Country
United States
Facility Name
Local Institution - 0233
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Local Institution - 0057
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174-1139
Country
United States
Facility Name
Local Institution - 0002
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Local Institution - 0038
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
BayCare Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Local Institution - 0206
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Local Institution - 0022
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Local Institution - 0083
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Arthritis Research and Treatment Center
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Klein & Associates
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Klein and Associates
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Advanced Rheumatology - Lansing
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455-0341
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Local Institution - 0011
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
SUNY Downstate Health Science University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Local Institution - 0082
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Local Institution - 0109
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 0232
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Local Institution - 0119
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7280
Country
United States
Facility Name
Local Institution - 0026
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Local Institution - 0180
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Local Institution - 0197
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Local Institution - 0174
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Local Institution - 0190
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0001
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Local Institution - 0087
City
Austin
State/Province
Texas
ZIP/Postal Code
78731-3146
Country
United States
Facility Name
Local Institution - 0086
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Pioneer Research Solutions
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429-5890
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Local Institution - 0193
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Local Institution - 0204
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Local Institution - 0061
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Local Institution - 0047
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Arthritis and Osteoporosis Center of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Local Institution - 0171
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320-4985
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Arthritis Northwest, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Local Institution - 0166
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1114AAF
Country
Argentina
Facility Name
Local Institution - 0139
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1430
Country
Argentina
Facility Name
Local Institution - 0185
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1046AAQ
Country
Argentina
Facility Name
Local Institution - 0136
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1111AAL
Country
Argentina
Facility Name
Local Institution - 0138
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1425AGC
Country
Argentina
Facility Name
Local Institution - 0152
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000PBJ
Country
Argentina
Facility Name
Local Institution - 0097
City
San Miguel De Tucum
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Local Institution - 0096
City
Cordoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
Hospital Privado Centro Medico de Cordoba
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Local Institution - 0137
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Local Institution - 0241
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Heidelberg Repatriation Hospital
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Local Institution - 0130
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40150150
Country
Brazil
Facility Name
Local Institution - 0129
City
Goiania
State/Province
Goias
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Santa Casa de Misericordia de Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-223
Country
Brazil
Facility Name
Local Institution - 0125
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Local Institution - 0126
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Local Institution - 0128
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
SAO Paulo
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Local Institution - 0151
City
Sao Bernardo do Campo
State/Province
SAO Paulo
ZIP/Postal Code
09715-090
Country
Brazil
Facility Name
CITIPA - Centro de Imunoterapia de Ipanema
City
Rio de Janeiro
ZIP/Postal Code
22221-020
Country
Brazil
Facility Name
Local Institution - 0148
City
Sao Paulo
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
Local Institution - 0247
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
Local Institution - 0245
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Local Institution - 0098
City
Barranquilla
ZIP/Postal Code
080002
Country
Colombia
Facility Name
Local Institution - 0099
City
Barranquilla
ZIP/Postal Code
0
Country
Colombia
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)
City
Bogota
Country
Colombia
Facility Name
Medicity SAS
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Facility Name
Local Institution - 0161
City
Cali
Country
Colombia
Facility Name
Local Institution - 0100
City
Chia
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Local Institution - 0159
City
Zipaquira
ZIP/Postal Code
250252
Country
Colombia
Facility Name
Allergie-Centrum-Charite Campus Charite Mitte Klinik fur Dermatologie Venerologie und Allergologi
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Klinik fur Nieren- und Hochdruckerkrankungen
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz - I. Medizinische Klinik und Poliklin
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Local Institution - 0035
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Local Institution - 0123
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
33394
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
9122001
Country
Israel
Facility Name
Local Institution
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Local Institution
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Local Institution
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution - 0117
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Kameda Clinic
City
Kamogawa-shi
State/Province
Chiba
ZIP/Postal Code
296-0041
Country
Japan
Facility Name
Local Institution - 0177
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Local Institution - 0141
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608604
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai City
State/Province
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Tomishiro Central Hospital
City
Tomigusuku-shi
State/Province
Okinawa
ZIP/Postal Code
9010243
Country
Japan
Facility Name
Dokkyo Medical University
City
Shimotsuga-gun
State/Province
Tochigi
ZIP/Postal Code
3210293
Country
Japan
Facility Name
Local Institution - 0183
City
Shimotsuke-city
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Local Institution - 0154
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Local Institution - 0144
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
1738610
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Facility Name
Kanazawa University Hospital
City
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Local Institution - 0162
City
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Showa University Hospital
City
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center
City
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Local Institution - 0133
City
Tokyo
ZIP/Postal Code
162-8655
Country
Japan
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Facility Name
Local Institution
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Facility Name
Local Institution - 0253
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Local Institution - 0054
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution - 0050
City
Suwon
ZIP/Postal Code
16499
Country
Korea, Republic of
Facility Name
Local Institution - 0140
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Local Institution - 0173
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06760
Country
Mexico
Facility Name
Local Institution - 0163
City
Leon, Guanajuato
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Local Institution - 0172
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37160
Country
Mexico
Facility Name
Local Institution - 0135
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Local Institution - 0156
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Juan Alberto Rodriguez Ruiz
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45116
Country
Mexico
Facility Name
Local Institution - 0134
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64000
Country
Mexico
Facility Name
Local Institution - 0149
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Faicic S. de R.L. de C.V.
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Facility Name
Local Institution - 0089
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Centrum Medyczne Pratia w Gdyni
City
Gdynia
ZIP/Postal Code
81-338
Country
Poland
Facility Name
Silmedic Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-282
Country
Poland
Facility Name
Zespol Opieki Zdrowotnej w Konskich
City
Konskie
ZIP/Postal Code
26-200
Country
Poland
Facility Name
Local Institution - 0182
City
Koscian
ZIP/Postal Code
64-000
Country
Poland
Facility Name
Local Institution - 0211
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Facility Name
Local Institution - 0222
City
Krakow
ZIP/Postal Code
31-011
Country
Poland
Facility Name
Centrum Medyczne ProMiMed
City
Krak
ZIP/Postal Code
31-637
Country
Poland
Facility Name
REUMED Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-607
Country
Poland
Facility Name
Medyczne Centrum Hetmanska - Poznan
City
Poznan
ZIP/Postal Code
60-218
Country
Poland
Facility Name
Solumed Centrum Medyczne
City
Poznan
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Med-Polonia
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Local Institution - 0093
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
Facility Name
SANUS Szpital Specjalistyczny
City
Stalowa Wola
ZIP/Postal Code
37-450
Country
Poland
Facility Name
Local Institution - 0219
City
Warszawa
ZIP/Postal Code
00-660
Country
Poland
Facility Name
Local Institution - 0192
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Local Institution - 0090
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Centrum Medyczne AMED Warszawa Targowek
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Local Institution - 0077
City
Wroclaw
ZIP/Postal Code
50-363
Country
Poland
Facility Name
Local Institution - 0184
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Local Institution - 0025
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Neomed Research
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Centrul Medical Sana
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Facility Name
Spitalul Sfanta Maria
City
Bucuresti
ZIP/Postal Code
011172
Country
Romania
Facility Name
Spitalul Clinic Dr. Ioan Cantacuzino
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Spitalul Clinic Judeߥan de Urgenߡ Sfantul Apostol Andrei
City
Galati
ZIP/Postal Code
800578
Country
Romania
Facility Name
Spitalul Judetean de Urgenta Valcea
City
Ramnicu Valcea
ZIP/Postal Code
240277
Country
Romania
Facility Name
CjSC
City
Ekaterinburg
ZIP/Postal Code
620043
Country
Russian Federation
Facility Name
Kemerovo State Medical University
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Medical Center Maksimum Zdorovia
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Local Institution - 0210
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Local Institution - 0006
City
Orenburg
ZIP/Postal Code
460018
Country
Russian Federation
Facility Name
State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Local Institution - 0207
City
Saint - Petersburg
ZIP/Postal Code
191045
Country
Russian Federation
Facility Name
Clinical Rheumatological Hospital Number 25
City
Saint Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Polyclinic of Private Security Personnel
City
Saint Petersburg
ZIP/Postal Code
192007
Country
Russian Federation
Facility Name
Private Healthcare Institution Clinical Hospital
City
Smolensk
ZIP/Postal Code
214025
Country
Russian Federation
Facility Name
Local Institution - 0223
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Tolyatti city clinical hospital ߵ
City
Tolyatti
ZIP/Postal Code
445039
Country
Russian Federation
Facility Name
Biomed
City
Vladimir
ZIP/Postal Code
600005
Country
Russian Federation
Facility Name
Local Institution - 0208
City
Yaroslavl
ZIP/Postal Code
150002
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2
City
Yaroslavl
ZIP/Postal Code
150030
Country
Russian Federation
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coru
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitari Vall dHebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga Hospital General
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital de Merida
City
Merida
ZIP/Postal Code
06800
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Local Institution - 0228
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Local Institution
City
Changhua City
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Local Institution - 0114
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
Facility Name
Local Institution
City
Taipei City
ZIP/Postal Code
10630
Country
Taiwan
Facility Name
Local Institution - 0088
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33687069
Citation
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Results Reference
derived
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.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
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 BMS-986165 in Participants With Systemic Lupus Erythematosus

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