An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
NCT ID: NCT03252587
Last Updated: 2022-12-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
363 participants
INTERVENTIONAL
2017-09-21
2021-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BMS-986165 Dose 1 oral administration
BMS-986165
Specified dose on specified days
BMS-986165 Dose 2 oral administration
BMS-986165
Specified dose on specified days
BMS-986165 Dose 3 oral administration
BMS-986165
Specified dose on specified days
Placebo oral administration
Placebo
Specified dose on specified days
Interventions
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BMS-986165
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0178
Birmingham, Alabama, United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States
Local Institution - 0023
El Cajon, California, United States
BioSolutions Clinical Research Center
La Mesa, California, United States
Los Angeles County Hospital and University of Southern California Medical Center
Los Angeles, California, United States
University of California at Irvine College of Medicine
Orange, California, United States
Local Institution - 0227
Palm Desert, California, United States
Millennium Clinical Trials - Thousand Oaks
Thousand Oaks, California, United States
The Lundquist Institute at Harbor-UCLA Medical Center
Torrance, California, United States
Inland Rheumatology Clinical Trials
Upland, California, United States
Local Institution - 0034
Farmington, Connecticut, United States
Local Institution - 0195
New Haven, Connecticut, United States
Local Institution - 0010
Aventura, Florida, United States
Local Institution - 0066
Brandon, Florida, United States
Local Institution - 0214
Gainesville, Florida, United States
Local Institution - 0233
Orlando, Florida, United States
Local Institution - 0057
Ormond Beach, Florida, United States
Local Institution - 0002
Tamarac, Florida, United States
Local Institution - 0038
Tampa, Florida, United States
BayCare Medical Group
Tampa, Florida, United States
Local Institution - 0206
Atlanta, Georgia, United States
Local Institution - 0022
Decatur, Georgia, United States
Local Institution - 0083
Lawrenceville, Georgia, United States
Arthritis Research and Treatment Center
Stockbridge, Georgia, United States
Klein & Associates
Cumberland, Maryland, United States
Klein and Associates
Hagerstown, Maryland, United States
Advanced Rheumatology - Lansing
Lansing, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Local Institution - 0011
Brooklyn, New York, United States
SUNY Downstate Health Science University
Brooklyn, New York, United States
Local Institution - 0082
Lake Success, New York, United States
Local Institution - 0109
New York, New York, United States
Local Institution - 0232
New York, New York, United States
Local Institution - 0119
Chapel Hill, North Carolina, United States
Local Institution - 0026
Charlotte, North Carolina, United States
Local Institution - 0180
Oklahoma City, Oklahoma, United States
Local Institution - 0197
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Local Institution - 0174
Wyomissing, Pennsylvania, United States
Local Institution - 0190
Charleston, South Carolina, United States
Local Institution - 0001
Jackson, Tennessee, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
Local Institution - 0087
Austin, Texas, United States
Local Institution - 0086
Austin, Texas, United States
Pioneer Research Solutions
Cypress, Texas, United States
Baylor Research Institute
Dallas, Texas, United States
Local Institution - 0193
Dallas, Texas, United States
Local Institution - 0204
Houston, Texas, United States
Local Institution - 0061
Houston, Texas, United States
Local Institution - 0047
Mesquite, Texas, United States
Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas, United States
Local Institution - 0171
Chesapeake, Virginia, United States
University of Washington
Seattle, Washington, United States
Arthritis Northwest, PLLC
Spokane, Washington, United States
Local Institution - 0166
Caba, Buenos Aires, Argentina
Local Institution - 0139
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0185
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0136
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0138
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0152
Rosario, Santa Fe Province, Argentina
Local Institution - 0097
San Miguel de Tucum, Tucumán Province, Argentina
Local Institution - 0096
Córdoba, , Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, , Argentina
Local Institution - 0137
Mendoza, , Argentina
Local Institution - 0241
Maroochydore, Queensland, Australia
Heidelberg Repatriation Hospital
Heidelberg West, Victoria, Australia
Local Institution - 0130
Salvador, Estado de Bahia, Brazil
Local Institution - 0129
Goiânia, Goiás, Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0125
Juiz de Fora, Minas Gerais, Brazil
Local Institution - 0126
Curitiba, Paraná, Brazil
Local Institution - 0128
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, São Paulo, Brazil
Local Institution - 0151
São Bernardo do Campo, São Paulo, Brazil
CITIPA - Centro de Imunoterapia de Ipanema
Rio de Janeiro, , Brazil
Local Institution - 0148
São Paulo, , Brazil
Local Institution - 0247
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
Local Institution - 0245
Toronto, Ontario, Canada
Local Institution - 0098
Barranquilla, , Colombia
Local Institution - 0099
Barranquilla, , Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)
Bogotá, , Colombia
Medicity SAS
Bucaramanga, , Colombia
Local Institution - 0161
Cali, , Colombia
Local Institution - 0100
Chía, , Colombia
Local Institution - 0159
Zipaquirá, , Colombia
Allergie-Centrum-Charite Campus Charite Mitte Klinik fur Dermatologie Venerologie und Allergologi
Berlin, , Germany
Klinik fur Nieren- und Hochdruckerkrankungen
Hanover, , Germany
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz - I. Medizinische Klinik und Poliklin
Mainz, , Germany
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Local Institution - 0035
Gyula, , Hungary
Local Institution - 0123
Szeged, , Hungary
Local Institution
Haifa, , Israel
Local Institution
Jerusalem, , Israel
Local Institution
Kfar Saba, , Israel
Local Institution
Petah Tikva, , Israel
Local Institution
Tel Litwinsky, , Israel
Local Institution - 0117
Chiba, Chiba, Japan
Kameda Clinic
Kamogawa-shi, Chiba, Japan
Local Institution - 0177
Kitakyushu, Fukuoka, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Local Institution - 0141
Sapporo, Hokkaido, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Tomishiro Central Hospital
Tomigusuku-shi, Okinawa, Japan
Dokkyo Medical University
Shimotsuga-gun, Tochigi, Japan
Local Institution - 0183
Shimotsuke, Tochigi, Japan
Local Institution - 0154
Chuo-ku, Tokyo, Japan
Local Institution - 0144
Itabashi-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Kanazawa University Hospital
Ishikawa, , Japan
Local Institution - 0162
Tokyo, , Japan
Showa University Hospital
Tokyo, , Japan
National Hospital Organization Tokyo Medical Center
Tokyo, , Japan
Local Institution - 0133
Tokyo, , Japan
Local Institution - 0163
León, Guanajuato, Mexico
Local Institution - 0172
León, Guanajuato, Mexico
Local Institution - 0135
Guadalajara, Jalisco, Mexico
Local Institution - 0156
Zapopan, Jalisco, Mexico
Juan Alberto Rodriguez Ruiz
Zapopan, Jalisco, Mexico
Local Institution - 0173
Mexico City, Mexico City, Mexico
Local Institution - 0140
Mexico City, Mexico City, Mexico
Local Institution - 0134
Monterrey, Nuevo León, Mexico
Local Institution - 0149
San Luis Potosí City, , Mexico
Faicic S. de R.L. de C.V.
Veracruz, , Mexico
Local Institution - 0089
Bydgoszcz, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej BIF-MED S.C
Bytom, , Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Centrum Medyczne Pratia w Gdyni
Gdynia, , Poland
Zespol Opieki Zdrowotnej w Konskich
Gmina Końskie, , Poland
Silmedic Sp. z o.o.
Katowice, , Poland
Local Institution - 0182
Kościan, , Poland
Local Institution - 0211
Krakow, , Poland
Local Institution - 0222
Krakow, , Poland
Centrum Medyczne ProMiMed
Krak, , Poland
REUMED Sp. z o.o.
Lublin, , Poland
Medyczne Centrum Hetmanska - Poznan
Poznan, , Poland
Solumed Centrum Medyczne
Poznan, , Poland
Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Med-Polonia
Poznan, , Poland
Local Institution - 0093
Sosnowiec, , Poland
SANUS Szpital Specjalistyczny
Stalowa Wola, , Poland
Local Institution - 0219
Warsaw, , Poland
Local Institution - 0192
Warsaw, , Poland
Local Institution - 0090
Warsaw, , Poland
Centrum Medyczne AMED Warszawa Targowek
Warsaw, , Poland
Local Institution - 0077
Wroclaw, , Poland
Local Institution - 0184
Wroclaw, , Poland
Local Institution - 0025
Wroclaw, , Poland
Neomed Research
Brasov, , Romania
Centrul Medical Sana
Bucharest, , Romania
Spitalul Sfanta Maria
Bucharest, , Romania
Spitalul Clinic Dr. Ioan Cantacuzino
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, , Romania
Spitalul Clinic Judeߥan de Urgenߡ Sfantul Apostol Andrei
Galati, , Romania
Spitalul Judetean de Urgenta Valcea
Râmnicu Vâlcea, , Romania
Kemerovo State Medical University
Kemerovo, , Russia
Medical Center Maksimum Zdorovia
Kemerovo, , Russia
Local Institution - 0210
Novosibirsk, , Russia
Local Institution - 0006
Orenburg, , Russia
State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova
Petrozavodsk, , Russia
Clinical Rheumatological Hospital Number 25
Saint Petersburg, , Russia
Local Institution - 0207
Saint Petersburg, , Russia
Polyclinic of Private Security Personnel
Saint Petersburg, , Russia
Local Institution - 0223
Saint Petersburg, , Russia
Private Healthcare Institution Clinical Hospital
Smolensk, , Russia
Tolyatti city clinical hospital ߵ
Tolyatti, , Russia
Biomed
Vladimir, , Russia
Local Institution - 0208
Yaroslavl, , Russia
State Budgetary Healthcare Institution of the Yaroslavl Region Clinical Hospital No. 2
Yaroslavl, , Russia
CjSC
Yekaterinburg, , Russia
Local Institution
Daegu, , South Korea
Local Institution
Daegu, , South Korea
Local Institution
Daejeon, , South Korea
Local Institution - 0253
Gwangju, , South Korea
Local Institution
Incheon, , South Korea
Local Institution - 0054
Seoul, , South Korea
Local Institution - 0050
Suwon, , South Korea
Complejo Hospitalario Universitario A Coruna
A Coru, , Spain
Hospital Universitari Vall dHebron
Barcelona, , Spain
Hospital Regional Universitario de Malaga Hospital General
Málaga, , Spain
Hospital de Merida
Mérida, , Spain
Corporacio Sanitaria Parc Tauli
Sabadell, , Spain
Local Institution - 0228
Seville, , Spain
Local Institution
Changhua, , Taiwan
Local Institution - 0114
Taichung, , Taiwan
Local Institution - 0088
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taipei, , Taiwan
Local Institution
Taoyuan District, , Taiwan
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2017-001203-79
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IM011-021
Identifier Type: -
Identifier Source: org_study_id