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AzTrials

Systemic Lupus ErythematosusPhase 2NCT03252587

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

A Phase 2 study testing BMS-986165 in people with Systemic Lupus Erythematosus, run by Bristol-Myers Squibb at 192 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
BMS-986165
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
363 participants
Where
192 sitesin 17 countries
Study dates
21 Sep 2017to 28 Oct 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

192 sites in 17 countries.

192 sites in 17 countries

United States55 sites

  • Local Institution - 0206

    Atlanta, Georgia, 30303

  • Local Institution - 0087

    Austin, Texas, 78731-3146

  • Local Institution - 0086

    Austin, Texas, 78745

  • Local Institution - 0010

    Aventura, Florida, 33180

  • Local Institution - 0178

    Birmingham, Alabama, 35205

  • Local Institution - 0066

    Brandon, Florida, 33511

  • Local Institution - 0011

    Brooklyn, New York, 11201

  • SUNY Downstate Health Science University

    Brooklyn, New York, 11203

  • Local Institution - 0119

    Chapel Hill, North Carolina, 27599-7280

  • Local Institution - 0190

    Charleston, South Carolina, 29425

  • Local Institution - 0026

    Charlotte, North Carolina, 28204

  • Local Institution - 0171

    Chesapeake, Virginia, 23320-4985

  • Klein & Associates

    Cumberland, Maryland, 21502

  • Pioneer Research Solutions

    Cypress, Texas, 77429-5890

  • Baylor Research Institute

    Dallas, Texas, 75231

  • Local Institution - 0193

    Dallas, Texas, 75390

  • Local Institution - 0022

    Decatur, Georgia, 30033

  • Local Institution - 0023

    El Cajon, California, 92020

  • Local Institution - 0034

    Farmington, Connecticut, 06030-5353

  • Local Institution - 0214

    Gainesville, Florida, 32603

  • Klein and Associates

    Hagerstown, Maryland, 21740

  • Local Institution - 0204

    Houston, Texas, 77084

  • Local Institution - 0061

    Houston, Texas, 77089

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Local Institution - 0001

    Jackson, Tennessee, 38305

  • BioSolutions Clinical Research Center

    La Mesa, California, 91942

  • Local Institution - 0082

    Lake Success, New York, 11042

  • Advanced Rheumatology - Lansing

    Lansing, Michigan, 48910

  • Local Institution - 0083

    Lawrenceville, Georgia, 30046

  • Little Rock Diagnostic Clinic

    Little Rock, Arkansas, 72205

  • Los Angeles County Hospital and University of Southern California Medical Center

    Los Angeles, California, 90033

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

  • Local Institution - 0047

    Mesquite, Texas, 75150

  • University of Minnesota

    Minneapolis, Minnesota, 55455-0341

  • Local Institution - 0195

    New Haven, Connecticut, 06520-8018

  • Local Institution - 0109

    New York, New York, 10016

  • Local Institution - 0232

    New York, New York, 10032

  • Local Institution - 0180

    Oklahoma City, Oklahoma, 73103

  • Local Institution - 0197

    Oklahoma City, Oklahoma, 73104

  • University of California at Irvine College of Medicine

    Orange, California, 92868

  • Local Institution - 0233

    Orlando, Florida, 32808

  • Local Institution - 0057

    Ormond Beach, Florida, 32174-1139

  • Local Institution - 0227

    Palm Desert, California, 92260

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261

  • Arthritis and Osteoporosis Center of South Texas

    San Antonio, Texas, 78232

  • University of Washington

    Seattle, Washington, 98195

  • Arthritis Northwest, PLLC

    Spokane, Washington, 99204

  • Arthritis Research and Treatment Center

    Stockbridge, Georgia, 30281

  • Local Institution - 0002

    Tamarac, Florida, 33321

  • Local Institution - 0038

    Tampa, Florida, 33613

  • BayCare Medical Group

    Tampa, Florida, 33614

  • Millennium Clinical Trials - Thousand Oaks

    Thousand Oaks, California, 91360

  • The Lundquist Institute at Harbor-UCLA Medical Center

    Torrance, California, 90502

  • Inland Rheumatology Clinical Trials

    Upland, California, 91786

  • Local Institution - 0174

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Poland23 sites

  • Local Institution - 0089

    Bydgoszcz, 85-168

  • Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C

    Bytom, 41-902

  • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

    Elblag, 82-300

  • Centrum Medyczne Pratia w Gdyni

    Gdynia, 81-338

  • Zespol Opieki Zdrowotnej w Konskich

    Gmina Końskie, 26-200

  • Silmedic Sp. z o.o.

    Katowice, 40-282

  • Local Institution - 0182

    Kościan, 64-000

  • Centrum Medyczne ProMiMed

    Krak, 31-637

  • Local Institution - 0211

    Krakow, 30-363

  • Local Institution - 0222

    Krakow, 31-011

  • REUMED Sp. z o.o.

    Lublin, 20-607

  • Medyczne Centrum Hetmanska - Poznan

    Poznan, 60-218

  • Solumed Centrum Medyczne

    Poznan, 60-529

  • Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Med-Polonia

    Poznan, 60-693

  • Local Institution - 0093

    Sosnowiec, 41-200

  • SANUS Szpital Specjalistyczny

    Stalowa Wola, 37-450

  • Local Institution - 0219

    Warsaw, 00-660

  • Local Institution - 0192

    Warsaw, 01-868

  • Local Institution - 0090

    Warsaw, 02-691

  • Centrum Medyczne AMED Warszawa Targowek

    Warsaw, 03-291

  • Local Institution - 0077

    Wroclaw, 50-363

  • Local Institution - 0184

    Wroclaw, 51-685

  • Local Institution - 0025

    Wroclaw, 52-416

Other trials in Poland

Japan17 sites

  • Local Institution - 0117

    Chiba, Chiba, 260-8712

  • Local Institution - 0154

    Chuo-ku, Tokyo, 104-8560

  • Kanazawa University Hospital

    Ishikawa, 920-8641

  • Kameda Clinic

    Kamogawa-shi, Chiba, 296-0041

  • Local Institution - 0177

    Kitakyushu, Fukuoka, 807-8556

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Local Institution - 0141

    Sapporo, Hokkaido, 0608604

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Dokkyo Medical University

    Shimotsuga-gun, Tochigi, 3210293

  • Local Institution - 0183

    Shimotsuke, Tochigi, 329-0498

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 1608582

  • Local Institution - 0144

    tabashi City, Tokyo, 1738610

  • Local Institution - 0162

    Tokyo, 113-8431

  • Showa University Hospital

    Tokyo, 142-8666

  • National Hospital Organization Tokyo Medical Center

    Tokyo, 152-8902

  • Local Institution - 0133

    Tokyo, 162-8655

  • Tomishiro Central Hospital

    Tomigusuku-shi, Okinawa, 9010243

Other trials in Japan

Russia15 sites

  • Kemerovo State Medical University

    Kemerovo, 650000

  • Medical Center Maksimum Zdorovia

    Kemerovo, 650066

  • Local Institution - 0210

    Novosibirsk, 630099

  • Local Institution - 0006

    Orenburg, 460018

  • State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova

    Petrozavodsk, 185019

  • Clinical Rheumatological Hospital Number 25

    Saint Petersburg, 190068

  • Local Institution - 0207

    Saint Petersburg, 191045

  • Polyclinic of Private Security Personnel

    Saint Petersburg, 192007

  • Local Institution - 0223

    Saint Petersburg, 197341

  • Private Healthcare Institution Clinical Hospital

    Smolensk, 214025

  • Tolyatti city clinical hospital ߵ

    Tolyatti, 445039

  • Biomed

    Vladimir, 600005

  • Local Institution - 0208

    Yaroslavl, 150002

  • State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2

    Yaroslavl, 150030

  • CjSC

    Yekaterinburg, 620043

Other trials in Russia

Argentina10 sites

  • Local Institution - 0166

    Caba, Buenos Aires, C1114AAF

  • Local Institution - 0139

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1430

  • Local Institution - 0185

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1046AAQ

  • Local Institution - 0136

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1111AAL

  • Local Institution - 0138

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC

  • Local Institution - 0096

    Córdoba, X5004FHP

  • Hospital Privado Centro Medico de Cordoba

    Córdoba, X5016KEH

  • Local Institution - 0137

    Mendoza, 5500

  • Local Institution - 0152

    Rosario, Santa Fe Province, S2000PBJ

  • Local Institution - 0097

    San Miguel de Tucum, Tucumán Province, T4000AXL

Other trials in Argentina

Brazil10 sites

  • Santa Casa de Misericordia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-223

  • Local Institution - 0126

    Curitiba, Paraná, 80030-110

  • Local Institution - 0129

    Goiânia, Goiás, 74110-120

  • Local Institution - 0125

    Juiz de Fora, Minas Gerais, 36010-570

  • Local Institution - 0128

    Porto Alegre, Rio Grande do Sul, 90480-000

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, São Paulo, 90035-903

  • CITIPA - Centro de Imunoterapia de Ipanema

    Rio de Janeiro, 22221-020

  • Local Institution - 0130

    Salvador, Estado de Bahia, 40150150

  • Local Institution - 0151

    São Bernardo do Campo, São Paulo, 09715-090

  • Local Institution - 0148

    São Paulo, 01228-200

Other trials in Brazil

Mexico10 sites

  • Local Institution - 0135

    Guadalajara, Jalisco, 44160

  • Local Institution - 0163

    León, Guanajuato, 37000

  • Local Institution - 0172

    León, Guanajuato, 37160

  • Local Institution - 0173

    Mexico City, Mexico City, 06760

  • Local Institution - 0140

    Mexico City, Mexico City, 11850

  • Local Institution - 0134

    Monterrey, Nuevo León, 64000

  • Local Institution - 0149

    San Luis Potosí City, 78213

  • Faicic S. de R.L. de C.V.

    Veracruz, 91900

  • Local Institution - 0156

    Zapopan, Jalisco, 45070

  • Juan Alberto Rodriguez Ruiz

    Zapopan, Jalisco, 45116

Other trials in Mexico

Colombia7 sites

  • Local Institution - 0098

    Barranquilla, 080002

  • Local Institution - 0099

    Barranquilla, 0

  • Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)

    Bogotá

  • Medicity SAS

    Bucaramanga, 680003

  • Local Institution - 0161

    Cali

  • Local Institution - 0100

    Chía, 250001

  • Local Institution - 0159

    Zipaquirá, 250252

Other trials in Colombia

Romania7 sites

  • Neomed Research

    Brasov, 500283

  • Centrul Medical Sana

    Bucharest, 011025

  • Spitalul Sfanta Maria

    Bucharest, 011172

  • Spitalul Clinic Dr. Ioan Cantacuzino

    Bucharest, 020475

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    Cluj-Napoca, 400006

  • Spitalul Clinic Judeߥan de Urgenߡ Sfantul Apostol Andrei

    Galati, 800578

  • Spitalul Judetean de Urgenta Valcea

    Râmnicu Vâlcea, 240277

Other trials in Romania

South Korea7 sites

  • Local Institution

    Daegu, 41944

  • Local Institution

    Daegu, 42601

  • Local Institution

    Daejeon, 35015

  • Local Institution - 0253

    Gwangju, 61469

  • Local Institution

    Incheon, 400-711

  • Local Institution - 0054

    Seoul, 03080

  • Local Institution - 0050

    Suwon, 16499

Other trials in South Korea

Taiwan7 sites

  • Local Institution

    Changhua, 500

  • Local Institution - 0114

    Taichung, 40201

  • Local Institution - 0088

    Taipei, 10002

  • Local Institution

    Taipei, 10630

  • Local Institution

    Taipei, 110

  • Local Institution

    Taipei, 11217

  • Local Institution

    Taoyuan, 333

Other trials in Taiwan

Spain6 sites

  • Complejo Hospitalario Universitario A Coruna

    A Coru, 15006

  • Hospital Universitari Vall dHebron

    Barcelona, 08035

  • Hospital Regional Universitario de Malaga Hospital General

    Málaga, 29010

  • Hospital de Merida

    Mérida, 06800

  • Corporacio Sanitaria Parc Tauli

    Sabadell, 08208

  • Local Institution - 0228

    Seville, 41014

Other trials in Spain

Israel5 sites

  • Local Institution

    Haifa, 33394

  • Local Institution

    Jerusalem, 9122001

  • Local Institution

    Kfar Saba, 4428164

  • Local Institution

    Petah Tikva, 4941492

  • Local Institution

    Tel HaShomer, 52621

Other trials in Israel

Canada4 sites

  • Local Institution - 0247

    Calgary, Alberta, T2N 4Z6

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2G3

  • McMaster University Medical Centre

    Hamilton, Ontario, L8S 4K1

  • Local Institution - 0245

    Toronto, Ontario, M5T 2S8

Other trials in Canada

Hungary4 sites

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Local Institution - 0035

    Gyula, 5700

  • Local Institution - 0123

    Szeged, 6725

Other trials in Hungary

Germany3 sites

  • Allergie-Centrum-Charite Campus Charite Mitte Klinik fur Dermatologie Venerologie und Allergologi

    Berlin, D-10117

  • Klinik fur Nieren- und Hochdruckerkrankungen

    Hanover, 30625

  • Universitatsmedizin der Johannes Gutenberg-Universitat Mainz - I. Medizinische Klinik und Poliklin

    Mainz, 55131

Other trials in Germany

Australia2 sites

  • Heidelberg Repatriation Hospital

    Heidelberg West, Victoria, 3081

  • Local Institution - 0241

    Maroochydore, Queensland, 4558

Other trials in Australia

About this study

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

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

Being tested
BMS-986165, Placebo
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986165Drug

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT03252587
Study groupRoleWhat they receive
BMS-986165 Dose 1 oral administrationExperimentalNot described
Receives: Drug: BMS-986165
BMS-986165 Dose 2 oral administrationExperimentalNot described
Receives: Drug: BMS-986165
BMS-986165 Dose 3 oral administrationExperimentalNot described
Receives: Drug: BMS-986165
Placebo oral administrationPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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:

    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

    Measured: At week 32

Secondary outcomes (19)

  1. 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:

    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

    Measured: At week 48

  2. 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:

    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

    Measured: At week 48

  3. Number of Participants Who Achieve Lupus Low Disease Activity State (LLDAS)

    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

    Measured: At Week 48

  4. 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

    Measured: At week 48

  5. 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:

    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.

    Measured: Baseline and week 48

  6. 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

    Measured: From first dose to 30 days post last dose (Up to 52 weeks)

  7. 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:

    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

    Measured: From first dose to 30 days post last dose (Up to 52 weeks)

  8. 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

    Measured: From first dose to 30 days post last dose (Up to 52 weeks)

  9. Number of Participants With Abnormalities in Electrocardiograms (ECGs)

    Number of participants with abnormalities in electrocardiograms (ECGs) assessed by QTcF, PR interval, and QRS interval

    Measured: From baseline to up to week 48

  10. 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.

    Measured: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 12

  11. 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.

    Measured: Pre-dose, 0.5, 2, 4, 6, and 10 hours post dose on week 12

  12. 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.

    Measured: Pre-dose, 0.5, 2, 4, and 6 hours post dose on week 2, 4, 8, 12, 24, 32, and 48

  13. 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.

    Measured: From baseline to week 44

  14. 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.

    Measured: From baseline to week 32

  15. 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.

    Measured: From baseline to week 52

  16. 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.

    Measured: From baseline to week 32

  17. 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.

    Measured: From baseline to week 52

  18. 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.

    Measured: From baseline to week 32

  19. 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:

    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

    Measured: At week 32

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2017
  2. Study start21 Sep 2017
  3. Primary completion29 Jun 2021
  4. Study completion28 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
363 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03252587
Sponsor's protocol ID
IM011-021
Other IDs
2017-001203-79, 2017
Status last verified
Nov 2022
First submitted
15 Aug 2017
Last updated
20 Dec 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Mosca M, Arnaud L, Askanase A, Hobar C, Becker B, Singhal S, Banerjee S, Pomponi S, Choi J, Strand V. Deucravacitinib, an oral, selective, allosteric, tyrosine kinase 2 inhibitor, in patients with active SLE: efficacy on patient-reported outcomes in a phase II randomised trial. Lupus Sci Med. 2025 Jun 1;12(1):e001517. doi: 10.1136/lupus-2025-001517.

    PubMed 40451616

  • Morand E, Pike M, Merrill JT, van Vollenhoven R, Werth VP, Hobar C, Delev N, Shah V, Sharkey B, Wegman T, Catlett I, Banerjee S, Singhal S. Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2023 Feb;75(2):242-252. doi: 10.1002/art.42391. Epub 2022 Nov 11.

    PubMed 36369798

  • 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.

    PubMed 33687069

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986165 in people with Systemic Lupus Erythematosus, run by Bristol-Myers Squibb at 192 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 192 sites in United States, Poland, Japan, Russia, Argentina and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32 (time frame: At week 32). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03252587, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.

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