A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
Launched by BRISTOL-MYERS SQUIBB · Nov 10, 2022
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called deucravacitinib to see how effective and safe it is for people with active systemic lupus erythematosus (SLE), a condition that can cause inflammation and damage in various parts of the body. The trial is looking for participants aged 18 to 75 who have been diagnosed with SLE for at least six months and have specific signs of disease activity. To join, participants must have been on stable background treatments for lupus for a certain period before the study.
Participants in this trial will receive either the new medication (deucravacitinib) or a placebo, which is a harmless pill that looks like the real drug but contains no active ingredients. Throughout the study, they will be closely monitored for any changes in their condition and for any side effects. This research is crucial because it may help improve treatments for SLE, which can be challenging to manage. It’s important to note that individuals with certain other health conditions or those taking specific medications may not be eligible to participate.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit.
- • Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.
- • One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening.
- • Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash.
- • Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry.
- • At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation.
- • Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant.
- • Exclusion Criteria
- • Diagnosis of drug-induced SLE rather than idiopathic SLE.
- • Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.
- • Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria.
- • Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.
- • History of congenital or acquired immunodeficiency.
- • Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria).
- • Taking more than 1 immunosuppressant at screening.
- • In Japan only: Participants with positive result of β - D-glucan assay.
- • Other protocol-defined Inclusion/Exclusion criteria apply.
About Bristol Myers Squibb
Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Ann Arbor, Michigan, United States
Boston, Massachusetts, United States
New York, New York, United States
New York, New York, United States
Oklahoma City, Oklahoma, United States
Charleston, South Carolina, United States
Boston, Massachusetts, United States
Liverpool, New South Wales, Australia
Philadelphia, Pennsylvania, United States
Sapporo, Hokkaido, Japan
Syracuse, New York, United States
Singapore, , Singapore
Ridgewood, New Jersey, United States
Cincinnati, Ohio, United States
Wheaton, Maryland, United States
Tokyo, , Japan
Santander, Cantabria, Spain
Fukuoka, , Japan
Okayama, , Japan
Taipei, , Taiwan
Tokyo, , Japan
Taichung, , Taiwan
Porto Alegre, Rio Grande Do Sul, Brazil
Dallas, Texas, United States
Jackson, Tennessee, United States
Praha 2, , Czechia
Barcelona, , Spain
Nagoya, Aichi, Japan
Nagasaki, , Japan
La Plata, Buenos Aires, Argentina
Fukushima, , Japan
Niigata, , Japan
Cleveland, Ohio, United States
Oaxaca, , Mexico
Sapporo, Hokkaido, Japan
Taipei, , Taiwan
Sagamihara, Kanagawa, Japan
Valladolid, , Spain
Santander, Cantabria, Spain
Austin, Texas, United States
Santiago, , Chile
Kawagoe, Saitama, Japan
Gifu, , Japan
Pilar, Buenos Aires, Argentina
Maroochydore, Queensland, Australia
London, Greater London, United Kingdom
Mérida, Badajoz, Spain
Sendai Shi, Miyagi, Japan
Victoria Park, Western Australia, Australia
Szeged, Csongrád, Hungary
Kitakyushu, Fukuoka, Japan
Yokohama, Kanagawa, Japan
Lisbon, , Portugal
San Juan, , Puerto Rico
Sevilla, , Spain
London, , United Kingdom
Florencio Varela, Buenos Aires, Argentina
Bangkok, Krung Thep Maha Nakhon, Thailand
Wakayama, , Japan
Porto Alegre, Rio Grande Do Sul, Brazil
Danville, Virginia, United States
Veszprem, , Hungary
Brooklyn, New York, United States
Lajeado, Rio Grande Do Sul, Brazil
Athens, , Greece
Wroclaw, , Poland
Osaka, , Japan
Toyoake, Aichi, Japan
Houston, Texas, United States
Szeged, , Hungary
Nagpur, Maharashtra, India
Rochester, Minnesota, United States
València, , Spain
Temple, Texas, United States
Chiba, , Japan
Clearwater, Florida, United States
San M. De Tucuman, Tucumán, Argentina
Bunkyō, Tokyo, Japan
Veszprem, Veszprém City, Hungary
Torreon, Coahuila, Mexico
Margate, Florida, United States
Vellore, Tamil Nadu, India
Oxford, , United Kingdom
Antalya, , Turkey
San Francisco, California, United States
Marietta, Georgia, United States
San Leandro, California, United States
Ostrava, , Czechia
Bilbo, País Vasco, Spain
Nagoya, Aichi, Japan
Shimotsuga, Tochigi, Japan
Lodz, , Poland
Katy, Texas, United States
Grand Blanc, Michigan, United States
El Paso, Texas, United States
São Paulo, , Brazil
Ostrava, Ostrava Město, Czechia
Hubli, Karnataka, India
Santiago, , Chile
Taichung, , Taiwan
São Paulo, , Brazil
Barretos, São Paulo, Brazil
Atlanta, Georgia, United States
Vitória, Espírito Santo, Brazil
Pécs, Baranya, Hungary
Mysore, Karnataka, India
Pergamino, Buenos Aires, Argentina
Torreón, Coahuila, Mexico
Warszawa, , Poland
Orland Park, Illinois, United States
Maroochydore, Queensland, Australia
Barcelona, Barcelona [Barcelona], Spain
Worcester, Massachusetts, United States
London, London, City Of, United Kingdom
Taichung City, Taichung, Taiwan
Kita, Kagawa, Japan
Mexico City, Distrito Federal, Mexico
Zapopan, Jalisco, Mexico
Grand Blanc, Michigan, United States
Bothell, Washington, United States
Athens, Attikí, Greece
Skokie, Illinois, United States
Lisbon, Lisboa, Portugal
Sao Bernardo Do Campo, São Paulo, Brazil
São Paulo, , Brazil
Elbląg, Warmińsko Mazurskie, Poland
Cuernavaca, Morelos, Mexico
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Rio De Janeiro, , Brazil
Saint Louis, Missouri, United States
Warszawa, Mazowieckie, Poland
Paramatta, New South Wales, Australia
La Jolla, California, United States
Lisbon, , Portugal
Jacksonville, Florida, United States
Pergamino, Buenos Aires, Argentina
San Miguel De Tucumán, Tucumán, Argentina
La Plata, , Argentina
Curitiba, Paraná, Brazil
Santo André, São Paulo, Brazil
Sao Bernardo Do Campo, São Paulo, Brazil
Rio De Janeiro, , Brazil
Valdivia, Los Ríos, Chile
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Praha 2, , Czechia
Athens, Attikí, Greece
Pécs, Baranya, Hungary
Gyula, Békés, Hungary
Veszprem, Veszprém City, Hungary
Nagoya, Aichi, Japan
Eiheiji Cho,Yoshida Gun, Fukui, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sagamihara, Kanagawa, Japan
Sasebo, Nagasaki, Japan
Bunkyo Ku, Tokyo, Japan
Itabashiku, Tokyo, Japan
Meguro Ku, Tokyo, Japan
Shinjyuku Ku, Tokyo, Japan
Chiba, , Japan
Fukushima, , Japan
Okayama, , Japan
Osaka, , Japan
Tokyo, , Japan
Tokyo, , Japan
Tokyo, , Japan
Torreon, Coahuila, Mexico
Mexico City, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Chihuahua, , Mexico
Chihuahua, , Mexico
Oaxaca, , Mexico
Lima, , Peru
Lima, , Peru
Lima, , Peru
Warszawa, Mazowieckie, Poland
Szczecin, Zachodniopomorskie, Poland
Warszawa, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Lodz, łódzkie, Poland
Lisbon, Lisboa, Portugal
Vila Nova De Gaia, Porto, Portugal
Barcelona, Barcelona [Barcelona], Spain
Santander, Cantabria, Spain
Sabadell, Catalunya [Cataluña], Spain
Cordoba, Córdoba, Spain
Bilbo, País Vasco, Spain
Vitoria Gasteiz, País Vasco, Spain
Sevilla, , Spain
Valladolid, , Spain
València, , Spain
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Taichung City, Taichung, Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
London, London, City Of, United Kingdom
London, London, City Of, United Kingdom
Cannock, Staffordshire, United Kingdom
Bradford, , United Kingdom
London, London, City Of, United Kingdom
Charlotte, North Carolina, United States
Pompano Beach, Florida, United States
Cuernavaca, Morelos, Mexico
Santa Monica, California, United States
Decatur, Georgia, United States
Colleyville, Texas, United States
Ciudad De Buenos Aires, Buenos Aires, Argentina
Florencio Varela, Buenos Aires, Argentina
Pilar, Buenos Aires, Argentina
San Miguel, Buenos Aires, Argentina
Quilmes, Ciudad Autónoma De Buenos Aires, Argentina
San M. De Tucuman, Tucumán, Argentina
San Juan, , Argentina
Victoria Park, Western Australia, Australia
Lajeado, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
São Paulo, , Brazil
La Serena, Coquimbo, Chile
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Athens, Attikí (Region), Greece
Larissa, Thessalía, Greece
Szeged, Csongrád, Hungary
Kitakyushu, Fukuoka, Japan
Sendai Shi, Miyagi, Japan
Kawagoe, Saitama, Japan
Nagasaki, , Japan
Niigata, , Japan
Wakayama, , Japan
Cdmx, Distrito Federal, Mexico
Mexico City, Distrito Federal, Mexico
Leon, Guanajuato, Mexico
Zapopan, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Lima, , Peru
Krakow, Małopolskie, Poland
Elbląg, Warmińsko Mazurskie, Poland
Poznan, Wielkopolskie, Poland
ód, łódzkie, Poland
Lisbon, , Portugal
Singapore, , Singapore
Singapore, , Singapore
Mérida, Badajoz, Spain
Cordoba, Madrid, Spain
Taipei, , Taiwan
London, , United Kingdom
Oxford, , United Kingdom
Santiago, , Chile
Nagoya, Aichi, Japan
Toyoake, Aichi, Japan
Asahikawa, Hokkaido, Japan
Vitória, Espírito Santo, Brazil
São Paulo, , Brazil
Yokohama, Kanagawa, Japan
Kraków, , Poland
Kita, Kagawa, Japan
Sasebo, Nagasaki, Japan
Hollywood, Florida, United States
Gifu, , Japan
Antalya, , Turkey
Bunkyo Ku, Tokyo, Japan
Central Middlesbrough, Middlesbrough, United Kingdom
Brooklyn, New York, United States
Istanbul, , Turkey
Shimotsuga, Tochigi, Japan
Bunkyō, Tokyo, Japan
Meguro Ku, Tokyo, Japan
Ostrava, Ostrava Město, Czechia
Río Cuarto, , Argentina
Barretos, São Paulo, Brazil
Itabashi Ku, Tokyo, Japan
Lima, , Peru
Taipei, , Taiwan
San Miguel, Buenos Aires, Argentina
Plovdiv, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Altindağ, Ankara, Turkey
Charlotte, North Carolina, United States
Lublin, Lubelskie, Poland
Warszawa, Mazowieckie, Poland
Lodz, łódzkie, Poland
Paramatta, New South Wales, Australia
Ivanhoe, Victoria, Australia
Shinjyuku Ku, Tokyo, Japan
Quilmes, Ciudad Autónoma De Buenos Aires, Argentina
Jacksonville, Florida, United States
Liverpool, New South Wales, Australia
Guadajalara, Jalisco, Mexico
Singapore, Central Singapore, Singapore
Santiago, Región Metropolitana De Santiago, Chile
Gaziantep, , Turkey
La Plata, Buenos Aires, Argentina
São Paulo, , Brazil
Curitiba, , Brazil
Ciudad De México, Distrito Federal, Mexico
Tainan City, , Taiwan
New Delhi, Delhi, India
Hubli, Karnataka, India
Hyderabad, Telangana, India
Ankara, , Turkey
Pittsburgh, Pennsylvania, United States
Vellore, Tamil Nadu, India
Las Vegas, Nevada, United States
Santiago, Región Metropolitana De Santiago, Chile
Leon, Guanajuato, Mexico
Guadalajara, Jalisco, Mexico
Warszawa, Mazowieckie, Poland
Szczecin, , Poland
Central Middlesbrough, Middlesbrough, United Kingdom
San Miguel De Tucumán, Tucumán, Argentina
Bangkok, Krung Thep Maha Nakhon, Thailand
Katy, Texas, United States
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Monterrey, Nuevo León, Mexico
Lima, , Peru
Santiago, Región Metropolitana De Santiago, Chile
Lublin, Lubelskie, Poland
Warszawa, Mazowieckie, Poland
Lodz, łódzkie, Poland
Ciudad De Buenos Aires, Buenos Aires, Argentina
Ivanhoe, Victoria, Australia
Ruse, , Bulgaria
La Serena, Coquimbo, Chile
Ciudad De México, Distrito Federal, Mexico
Chihuahua, , Mexico
Poznan, Wielkopolskie, Poland
Plovdiv, , Bulgaria
Pompano Beach, Florida, United States
Sofia, , Bulgaria
Athens, Attikí (Region), Greece
Larissa, Thessalía, Greece
Ahmedabad, Gujarat, India
Vellore, Tamil Nadu, India
Kraków, Małopolskie, Poland
Bila Nova De Gaia, , Portugal
Bangkok, Krung Thep Maha Nakhon, Thailand
Bangkok, Krung Thep Maha Nakhon, Thailand
Gyula, Békés, Hungary
Clearwater, Florida, United States
Sofia, , Bulgaria
Santiago, Región Metropolitana De Santiago, Chile
Asahikawa, Hokkaido, Japan
Lima, , Peru
Toyoma, Toyama, Japan
Bunkyo Ku, Tokyo, Japan
Bunkyo Ku, Tokyo, Japan
Paramus, New Jersey, United States
Santiago, Región Metropolitana De Santiago, Chile
Mexico City, Distrito Federal, Mexico
Guadajalara, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
Las Vegas, Nevada, United States
Paramus, New Jersey, United States
London, Greater London, United Kingdom
Sasebo, Nagasaki, Japan
Great Neck, New York, United States
Warszawa, Mazowieckie, Poland
Meguro Ku, Tokyo, Japan
Colleyville, Texas, United States
Sofia, Sofia (Stolitsa), Bulgaria
Santiago, Región Metropolitana De Santiago, Chile
Santiago, Región Metropolitana De Santiago, Chile
Mysore, Karnataka, India
Lima, , Peru
Wroclaw, Dolnośląskie, Poland
Chorzów, śląskie, Poland
London, England, United Kingdom
London, England, United Kingdom
Orland Park, Illinois, United States
Skokie, Illinois, United States
Las Vegas, Nevada, United States
Lima, , Peru
Cordoba, Madrid, Spain
Gaziantep, , Turkey
Charlotte, North Carolina, United States
Toyoma, Toyama, Japan
Lima, , Peru
Katy, Texas, United States
Fukuoka, , Japan
Bangkok, Krung Thep Maha Nakhon, Thailand
Great Neck, New York, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Chorzów, śląskie, Poland
Florence, South Carolina, United States
Florence, South Carolina, United States
Secundarabad, Telangana, India
Florence, South Carolina, United States
Nagpur, Maharashtra, India
Secundarabad, Telangana, India
Porto Alegre, Rio Grande Do Sul, Brazil
San Miguel De Tucumán, Tucumán, Argentina
Porto Velho, Rondônia, Brazil
San Miguel, Buenos Aires, Argentina
Delray Beach, Florida, United States
New Orleans, Louisiana, United States
Recife, Pernambuco, Brazil
Ahmedabad, Gujarat, India
Lisbon, , Portugal
San M. De Tucuman, , Argentina
Quilmes, , Argentina
Barretos, , Brazil
Bilbo, , Spain
Sao Bernardo Do Campo, , Brazil
Vitória, , Brazil
Athens, , Greece
San Miguel De Tucumán, , Argentina
Porto Velho, , Brazil
Santo André, , Brazil
Sofia, , Bulgaria
Valdivia, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Santiago, , Chile
Larissa, , Greece
Gyula, , Hungary
Wroclaw, , Poland
Elbląg, , Poland
Chorzów, , Poland
Vitoria Gasteiz, , Spain
Searcy, Arkansas, United States
Ahmedabad, Gujarat, India
Ahmedabad, Gujarat, India
Hyderabad, Telangana, India
Vila Nova De Gaia, Porto, Portugal
Larbert, Falkirk, United Kingdom
San Diego, California, United States
Plant City, Florida, United States
Charleston, South Carolina, United States
Porto Velho, , Brazil
Caguas, , Puerto Rico
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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