A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Launched by BRISTOL-MYERS SQUIBB · Nov 8, 2022
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called deucravacitinib to see how well it works and how safe it is for people with moderate to severe Systemic Lupus Erythematosus (SLE), a condition that can cause inflammation and pain in various parts of the body. Participants will be compared to those receiving a placebo, which is a treatment that looks like the medication but has no active ingredients. The trial is currently recruiting individuals aged 18 to 75 who have been diagnosed with SLE for at least six months and have specific signs of the disease, such as positive blood tests and certain symptoms like joint pain or skin rashes.
If you or someone you know is considering participating, it's important to know that participants will need to be on a stable background treatment for SLE for a certain period before joining the study, and they cannot have other serious autoimmune diseases or specific complications from lupus. Throughout the trial, participants will receive regular check-ups to monitor their health and how they respond to the treatment. This study aims to provide valuable information that could help improve treatment options for people living with SLE.
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.
- • 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
Birmingham, Alabama, United States
Baltimore, Maryland, United States
Rochester, New York, United States
Bronx, New York, United States
Detroit, Michigan, United States
Rochester, New York, United States
New Orleans, Louisiana, United States
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Toronto, Ontario, Canada
Birmingham, Alabama, United States
New Haven, Connecticut, United States
Dallas, Texas, United States
Seattle, Washington, United States
Gainesville, Florida, United States
Denver, Colorado, United States
Seattle, Washington, United States
London, Ontario, Canada
Hamilton, Ontario, Canada
Milano, , Italy
Miami, Florida, United States
Guangzhou, Guangdong, China
Anniston, Alabama, United States
Buenos Aires, , Argentina
Tucson, Arizona, United States
Bucuresti, , Romania
Manhasset, New York, United States
Lübeck, Schleswig Holstein, Germany
Changsha, Hunan, China
Leon, Guanajuato, Mexico
Brescia, , Italy
Erlangen, , Germany
Shenzhen, Guangdong, China
Shenyang, Liaoning, China
Guangzhou, Guangdong, China
Nanchang, Jiangxi, China
Shenyang, Liaoning, China
Tamarac, Florida, United States
Eagan, Minnesota, United States
Atlanta, Georgia, United States
Nanchang, Jiangxi, China
New York, New York, United States
Shanghai, , China
Suwon, , Korea, Republic Of
Wuhan, Hubei, China
Luoyang, Henan, China
Shanghai, Shanghai, China
Indianapolis, Indiana, United States
Kocaeli, , Turkey
Xiamen, Fujian, China
Seoul, , Korea, Republic Of
Chisinau, , Moldova, Republic Of
Juiz De Fora, Minas Gerais, Brazil
Urumqi, Xinjiang, China
Chihuahua, , Mexico
Zhuzhou, Hunan, China
Katowice, , Poland
Pisa, Toscana, Italy
Mexico, Distrito Federal, Mexico
São José Do Rio Preto, São Paulo, Brazil
Shanghai, Shanghai, China
Hohhot, Inner Mongolia, China
Changzhou, Jiangsu, China
Roanoke, Virginia, United States
Mexico City, Distrito Federal, Mexico
Fontana, California, United States
Hyderabad, Telangana, India
Tübingen, , Germany
Gwangju Si, , Korea, Republic Of
Pingxiang, Jiangxi, China
Poznan, , Poland
Lawrenceville, Georgia, United States
Chia, , Colombia
Krakow, , Poland
São José Do Rio Preto, , Brazil
Orlando, Florida, United States
Tampa, Florida, United States
Guangzhou, Guangdong, China
Jiujiang, Jiangxi, China
Bydgoszcz, Kujawsko Pomorskie, Poland
Bucuresti, , Romania
Mexicali, Baja California, Mexico
San Juan, , Puerto Rico
Dublin, , Ireland
Zhengzhou, Henan, China
Bogotá, , Colombia
Rio De Janeiro, , Brazil
Beijing, Beijing, China
Milano, Lombardia, Italy
Köln, , Germany
Caguas, , Puerto Rico
Hangzhou, Zhejiang, China
Zhengzhou, Henan, China
Napoli, , Italy
Bogota, , Colombia
Córdoba, , Argentina
Ahmedabad, Gujarat, India
Verona, , Italy
Memphis, Tennessee, United States
Schaumburg, Illinois, United States
Allen, Texas, United States
La Palma, California, United States
La Palma, California, United States
Allen, Texas, United States
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Ankara, , Turkey
Miami, Florida, United States
Istanbul, , Turkey
Dresden, Sachsen, Germany
São Paulo, , Brazil
Strasbourg, Alsace, France
Cutler Bay, Florida, United States
Tübingen, Baden Württemberg, Germany
Bengbu, Anhui, China
Tampa, Florida, United States
San Miguel De Tucuman, Tucumán, Argentina
Cork, , Ireland
Wenzhou, Zhejiang, China
Los Angeles, California, United States
Hemet, California, United States
Boca Raton, Florida, United States
Springboro, Ohio, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
The Woodlands, Texas, United States
Roanoke, Virginia, United States
Franklin, Wisconsin, United States
Caba, Buenos Aires, Argentina
Quilmes, Buenos Aires, Argentina
Buenos Aires, , Argentina
Lago Sul, Distrito Federal, Brazil
Juiz De Fora, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Niteroi, Rio De Janeiro, Brazil
São José Do Rio Preto, São Paulo, Brazil
São Paulo, , Brazil
London, Ontario, Canada
Toronto, Ontario, Canada
Bengbu, Anhui, China
Beijing, Beijing, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Baotou, Inner Mongolia, China
Hohhot, Inner Mongolia, China
Hohhot, Inner Mongolia, China
Nanchang, Jiangxi, China
Nanchang, Jiangxi, China
Shenyang, Liaoning, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Cheng Du, Sichuan, China
Tianjin, Tianjin, China
Barranquilla, Atlántico, Colombia
Bogotá, Distrito Capital De Bogotá, Colombia
Cali, Valle Del Cauca, Colombia
Cali, Valle Del Cauca, Colombia
Bucaramanga, , Colombia
Chía, , Colombia
Medellin, , Colombia
Nantes, Loire Atlantique, France
Tübingen, Baden Württemberg, Germany
Bad Abbach, Bayern, Germany
Erlangen, , Germany
Köln, , Germany
Planegg, , Germany
Tuen Mun, , Hong Kong
Manorhamilton, Leitrim, Ireland
Roma, Lazio, Italy
Milano, Lombardia, Italy
Milan, Milano, Italy
Padova, Veneto, Italy
Brescia, , Italy
Milano, , Italy
Pavia, , Italy
Pisa, , Italy
Gwangju Si, Kwangju Kwangyǒkshi, Korea, Republic Of
Suwon, Kyǒnggi Do, Korea, Republic Of
Jung Gu, Taegu Kwangyǒkshi, Korea, Republic Of
Jung Gu, Taejǒn Kwangyǒkshi, Korea, Republic Of
Mexico City, Distrito Federal, Mexico
Mexico City, Distrito Federal, Mexico
Mexico City, Distrito Federal, Mexico
Leon, Guanajuato, Mexico
Guadalajara, Jalisco, Mexico
Guadalajara, Jalisco, Mexico
Puebla, , Mexico
Lima, , Peru
Lima, , Peru
Lima, , Peru
Krakow, Małopolskie, Poland
Poznań, Wielkopolskie, Poland
Lisbon, , Portugal
Bucharest, București, Romania
Râmnicu Vâlcea, , Romania
Roma, Lazio, Italy
Plovdiv, , Bulgaria
Mendoza, , Argentina
Bucharest, București, Romania
Santa Barbara, California, United States
Great Neck, New York, United States
Charlotte, North Carolina, United States
Fort Worth, Texas, United States
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Caba, Ciudad Autónoma De Buenos Aires, Argentina
San Miguel De Tucuman, Tucumán, Argentina
Buenos Aires, , Argentina
Ciudad Autónoma De Buenos Aires, , Argentina
Córdoba, , Argentina
Mendoza, , Argentina
Belo Horizonte, Minas Gerais, Brazil
Juiz De Fora, Minas Gerais, Brazil
Sao Paulo, São Paulo, Brazil
Calgary, Alberta, Canada
Hamilton, Ontario, Canada
Rimouski, Quebec, Canada
Shenzhen, Guangdong, China
Baoding, Hebei, China
Luoyang, Henan, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Changsha, Hunan, China
Zhuzhou, Hunan, China
Changzhou, Jiangsu, China
Jiujiang, Jiangxi, China
Pingxiang, Jiangxi, China
Shenyang, Liaoning, China
Jinan, Shandong, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Urumqi, Xinjiang, China
Hangzhou, Zhejiang, China
Hangzhou, Zhejiang, China
Wenzhou, Zhejiang, China
Taiyuan, , China
Cali, Valle Del Cauca, Colombia
Strasbourg, Alsace, France
Tours, , France
Dresden, Sachsen, Germany
Lübeck, Schleswig Holstein, Germany
Cork, , Ireland
Dublin, , Ireland
Napoli, , Italy
Verona, , Italy
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Mexicali, Baja California, Mexico
Ciudad De México, Distrito Federal, Mexico
Mexico City, Distrito Federal, Mexico
Mexico, Distrito Federal, Mexico
Chihuahua, , Mexico
Bydgoszcz, Kujawsko Pomorskie, Poland
Nadarzyn, Mazowieckie, Poland
Bialystok, Podlaskie, Poland
Poznan, Wielkopolskie, Poland
Katowice, śląskie, Poland
Bucharest, București, Romania
Bucharest, București, Romania
Bucuresti, București, Romania
Timişoara, Timiș, Romania
Craiova, , Romania
Bucharest, București, Romania
Pisa, Toscana, Italy
Mexico City, , Mexico
Tours, , France
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Kaunas, Kauno Apskritis, Lithuania
Warsaw, Mazowieckie, Poland
Warszawa, Mazowieckie, Poland
Detroit, Michigan, United States
Belo Horizonte, Minas Gerais, Brazil
Cheng Du, Sichuan, China
Kaunas, Kauno Apskritis, Lithuania
Zapopan, Jalisco, Mexico
Istanbul, , Turkey
Ribeirão Preto, São Paulo, Brazil
Bogotá, , Colombia
Le Kremlin Bicêtre, , France
Dublin, , Ireland
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Suwon, Kyǒnggi Do, Korea, Republic Of
Medellín, Antioquia, Colombia
Râmnicu Vâlcea, , Romania
Summit, New Jersey, United States
Baoding, Hebei, China
München, Bayern, Germany
Nantes, Loire Atlantique, France
Le Kremlin Bicêtre, , France
Katowice, śląskie, Poland
Buena Park, California, United States
Salvador, Bahia, Brazil
Bialystok, , Poland
Craiova, Dolj, Romania
Porto Alegre, Rio Grande Do Sul, Brazil
Rio De Janeiro, , Brazil
Sofia, Sofia (Stolitsa), Bulgaria
Guangzhou, Guangdong, China
Gera, Thüringen, Germany
Ankara, , Turkey
New Albany, Indiana, United States
Ribeirão Preto, São Paulo, Brazil
Kocaeli, , Turkey
Curitiba, Paraná, Brazil
Caba, Buenos Aires, Argentina
Campinas, São Paulo, Brazil
Sao Paulo, São Paulo, Brazil
São José Do Rio Preto, São Paulo, Brazil
Seoul, , Korea, Republic Of
Padova, Veneto, Italy
Dublin, , Ireland
Bucuresti, București, Romania
Warsaw, Mazowieckie, Poland
Shanghai, , China
Chemnitz, Sachsen, Germany
Wroclaw, Dolnośląskie, Poland
Buenos Aires, , Argentina
São Paulo, , Brazil
Munchen, Bayern, Germany
Lago Sul, Distrito Federal, Brazil
Zhengzhou, Henan, China
Muenchen, Bayern, Germany
Arequipa, Ariqipa, Peru
Timisoara, , Romania
New Haven, Connecticut, United States
Shanghai, Shanghai, China
Ahmedabad, Gujarat, India
Gurugram, Haryana, India
Bengaluru, Karnataka, India
Hyderabad, Telangana, India
Memphis, Tennessee, United States
Fort Worth, Texas, United States
Quilmes, Buenos Aires, Argentina
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Caba, Ciudad Autónoma De Buenos Aires, Argentina
Ciudad De México, Distrito Federal, Mexico
Nadarzyn, Mazowieckie, Poland
Wolomin, Mazowieckie, Poland
Poznan, Wielkopolskie, Poland
Bialystok, , Poland
Timisoara, , Romania
Buenos Aires, , Argentina
Medellín, Antioquia, Colombia
Chía, , Colombia
Atlanta, Georgia, United States
Franklin, Wisconsin, United States
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Barranquilla, Atlántico, Colombia
Belchatow, łódzkie, Poland
Indianapolis, Indiana, United States
Buenos Aires, , Argentina
Bucharest, București, Romania
Gwangju Si, Kwangju Kwangyǒkshi, Korea, Republic Of
Lima, , Peru
Sofia, , Bulgaria
Rimouski, Quebec, Canada
Muenchen, Bayern, Germany
Krakow, Małopolskie, Poland
Poznan, Wielkopolskie, Poland
Campinas, São Paulo, Brazil
Chemnitz, , Germany
Vizianagaram, Andhra Pradesh, India
Bucharest, București, Romania
Bucuresti, București, Romania
Iasi, Iași, Romania
Svidnik, Prešovský Kraj, Slovakia
Martin, žilinský Kraj, Slovakia
Tuen Mun, , Hong Kong
Sofia, , Bulgaria
Bucaramanga, Santander, Colombia
Mexico City, Distrito Federal, Mexico
Puebla, , Mexico
Warszawa, Mazowieckie, Poland
Bucuresti, București, Romania
Bucharest, , Romania
Bucharest, , Romania
Taiyuan, , China
Bucaramanga, Santander, Colombia
Lubbock, Texas, United States
Sao Paulo, São Paulo, Brazil
Chemnitz, , Germany
Cali, Valle Del Cauca, Colombia
Sao Paulo, , Brazil
Ciudad Autónoma De Buenos Aires, , Argentina
Calgary, Alberta, Canada
Nanchang, Jiangxi, China
Bogotá, Distrito Capital De Bogotá, Colombia
Planegg, , Germany
Lima, , Peru
Lima, , Peru
Cali, , Colombia
Barranquilla, Atlántico, Colombia
Bogotá, , Colombia
Cali, , Colombia
Gurugram, Haryana, India
Hyderabad, Telangana, India
Wolomin, Mazowieckie, Poland
Bucharest, Bucureşti, Romania
Craiova, Dolj, Romania
Iasi, Iași, Romania
Râmnicu Vâlcea, Vâlcea, Romania
Gurugram, Haryana, India
Tucson, Arizona, United States
Orlando, Florida, United States
Salvador, Bahia, Brazil
Arequipa, Ariqipa, Peru
Schaumburg, Illinois, United States
Medellín, Antioquia, Colombia
Arequipa, , Peru
New Orleans, Louisiana, United States
Des Plaines, Illinois, United States
Hamilton, Ontario, Canada
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tampa, Florida, United States
Lawrenceville, Georgia, United States
Lawrenceville, Georgia, United States
Bengaluru, Karnataka, India
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Stellenbosch, Western Cape, South Africa
Bronx, New York, United States
Bengaluru, Karnataka, India
Chisinau, Chișinău, Moldova, Republic Of
Chisinau, Chișinău, Moldova, Republic Of
Chisinau, , Moldova, Republic Of
Denver, Colorado, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Seattle, Washington, United States
Pretoria, Gp, South Africa
Buenos Aires, , Argentina
Hyderabad, Telangana, India
Morton Grove, Illinois, United States
Ciudad Autónoma De Buenos Aires, , Argentina
Sofia, , Bulgaria
Bucharest, , Romania
San Miguel De Tucuman, , Argentina
Ribeirão Preto, , Brazil
Caba, , Argentina
Curitiba, , Brazil
Campinas, , Brazil
Barranquilla, , Colombia
Jung Gu, , Korea, Republic Of
Jung Gu, , Korea, Republic Of
Chisinau, , Moldova, Republic Of
Chisinau, , Moldova, Republic Of
Wroclaw, , Poland
Belchatow, , Poland
Bucharest, , Romania
Iasi, , Romania
Râmnicu Vâlcea, , Romania
Svidnik, , Slovakia
Martin, , Slovakia
Santa Barbara, California, United States
Plantation, Florida, United States
Bengbu, Anhui, China
Lublin, Lubelskie, Poland
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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