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

November 28, 2022 updated by: Bristol-Myers Squibb

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of BMS-986165 in Subjects With Systemic Lupus Erythematosus

This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

363

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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
Experimental: BMS-986165 Dose 3 oral administration
Drug: BMS-986165
Specified dose on specified days
Placebo Comparator: Placebo oral administration
Other: Placebo
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
Time Frame: At week 32

SRI(4) responder is defined as a patient whose disease course fulfills all of the following:

  1. A 4-point or greater reduction from baseline in SLEDAI-2K score
  2. 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
  3. 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
At week 32

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 48
Time Frame: At week 48

SRI(4) responder is defined as a patient whose disease course fulfills all of the following:

  1. A 4-point or greater reduction from baseline in SLEDAI-2K score
  2. 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
  3. 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
At week 48
Number of Participants Who Achieve British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) Response
Time Frame: At week 48

BICLA responder is defined as a patient whose disease course fulfills all of the following:

  1. Improvement in all organ systems with activity graded as BILAG-2004 A (severe disease activity) or B (moderate disease activity) at baseline
  2. No new organ system with activity graded as BILAG A; no more than 1 new organ system with activity graded as BILAG B
  3. No increase from baseline in Systemic Lupus Erythematosus SLEDAI-2K score (≤ 0 points for change from baseline score)
  4. 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
  5. No discontinuation of investigational product or use of restricted medications beyond the protocol allowed threshold before assessment
At week 48
Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)
Time Frame: At Week 48

LLDAS is defined as follows:

  1. 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
  2. No new lupus disease activity compared with the previous assessment measured as no new or worsening individual BILAG parameters
  3. Physician's Global Assessment of Disease Activity ≤ 1 on a 3-point visual analog scale from no disease activity to severe disease activity
  4. A current prednisolone (or equivalent) dose ≤ 7.5 mg daily
  5. Well-tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents
At Week 48
Number of Participants With a ≥50% Reduction in CLASI Activity Score in the Sub-group With Baseline CLASI Activity Score ≥10
Time Frame: At week 48
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
At week 48
Change From Baseline in the 40-Joint Count
Time Frame: Baseline and week 48

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:

  1. Tender joint count (0 to 40)
  2. Swollen joint count (0 to 40)
  3. Tender and swollen joint count (0 to 40) A larger joint count indicates more severe disease.
Baseline and week 48
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From first dose to 30 days post last dose (Up to 52 weeks)
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
From first dose to 30 days post last dose (Up to 52 weeks)
Number of Participants With Laboratory Abnormalities in Specific Liver Tests
Time Frame: From first dose to 30 days post last dose (Up to 52 weeks)

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:

  1. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) elevation > 3× Upper Limit of Normal (ULN)
  2. Total bilirubin > 2× ULN, without initial findings of cholestasis (elevated serum alkaline phosphatase)
  3. 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
From first dose to 30 days post last dose (Up to 52 weeks)
Number of Participants With Abnormalities in Vital Signs
Time Frame: From first dose to 30 days post last dose (Up to 52 weeks)
Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure
From first dose to 30 days post last dose (Up to 52 weeks)
Number of Participants With Abnormalities in Electrocardiograms (ECGs)
Time Frame: From baseline to up to week 48
Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval
From baseline to up to week 48
BMS-986165 and Its Active Metabolite BMT-153261 Maximum Observed Plasma Concentration (Cmax)
Time Frame: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12
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.
Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12
BMS-986165 and Its Active Metabolite BMT-153261 Time of Maximum Observed Plasma Concentration (Tmax)
Time Frame: Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12
Time of maximum observed plasma concentration (Tmax) for the following treatments: BMS-986165 and its active metabolite BMT-153261.
Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12
BMS-986165 and Its Active Metabolite BMT-153261 Trough Observed Plasma Concentration (Ctrough)
Time Frame: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48
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.
Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels
Time Frame: From baseline to week 44
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.
From baseline to week 44
Percent Change From Baseline in Interferon-Regulated Gene (IRG) Expression Levels at Week 32
Time Frame: From baseline to 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.
From baseline to week 32
Percent Change From Baseline in Complement Proteins C3 and C4 Levels
Time Frame: From baseline to week 52
Percent change from baseline in complement proteins C3 and C4 levels. Baseline values are defined as the last measurement before the first dose.
From baseline to week 52
Percent Change From Baseline in Complement (C3, C4) Levels at Week 32
Time Frame: From baseline to 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.
From baseline to week 32
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels
Time Frame: From baseline to week 52
Percent change from baseline in anti-double-stranded DNA (dsDNA) levels. Baseline values are defined as the last measurement before the first dose.
From baseline to week 52
Percent Change From Baseline in Anti-Double-Stranded DNA (dsDNA) Antibody Levels at Week 32
Time Frame: From baseline to 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.
From baseline to week 32
Number of Participants With Global Systemic Lupus Erythematosus (SLE) Clinical Response Based on Interferon-Regulated Gene (IRG) Status
Time Frame: At week 32

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:

  1. A 4-point or greater reduction from baseline in SLEDAI-2K score
  2. 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
  3. 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
At week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2017

Primary Completion (Actual)

June 29, 2021

Study Completion (Actual)

October 28, 2021

Study Registration Dates

First Submitted

August 15, 2017

First Submitted That Met QC Criteria

August 15, 2017

First Posted (Actual)

August 17, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM011-021
  • 2017-001203-79 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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