A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
Launched by BRISTOL-MYERS SQUIBB · Jul 7, 2023
Trial Information
Current as of June 26, 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 adults with active Sjögren's Syndrome, a condition that affects the body's ability to produce moisture, leading to dry mouth and eyes. The trial is looking for participants aged 18 and older who have been diagnosed with Sjögren's Syndrome for at least 16 weeks and have moderate to severe symptoms. To be eligible, participants need to have a specific level of saliva production and a positive test for certain antibodies related to the condition.
If you join the trial, you will receive either Deucravacitinib or a placebo (a dummy treatment that looks like the real medication) for a set period. Throughout the study, your health will be monitored to track any changes in your symptoms and to ensure your safety. It's important to know that certain other health conditions, like other autoimmune diseases, may exclude you from participating. This study is currently looking for volunteers, so it could be a chance to help advance treatments for Sjögren's Syndrome while potentially benefiting from new medication.
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Satisfy the 2016 American College of Rheumatology/European League Against Rheumatism criteria for the classification of SjS at screening (score ≥ 4), and who have disease duration (from time of initial clinical SjS diagnosis) of at least 16 weeks prior to screening.
- • Have moderate to severe SjS ESSDAI ≥ 5.
- • Short duration of disease (≤ 10 years) before screening.
- • A stimulated whole salivary flow (SWSF) ≥ 0.05 mililiters/minute (mL/minute).
- • Positive anti-Sjögren's syndrome-associated antigen A (anti-Ro/SSA) at screening.
- • Exclusion Criteria
- • Autoimmune disease other than SjS (for example, rheumatoid arthritis, systemic lupus erthrematosus \[SLE\], systemic sclerosis).
- • Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment or requiring adjustment in medication within the 3 months before screening to control symptoms; participants with fibromyalgia that is well controlled on stable treatment may otherwise be considered.
- • Medical condition associated with sicca syndrome.
- • Previous exposure to tyrosine kinase 2 (TYK2) inhibitors such as deucravacitinib or related compounds.
- • 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
Kansas City, Kansas, United States
Paris, , France
Boston, Massachusetts, United States
Seattle, Washington, United States
Duncansville, Pennsylvania, United States
Clearwater, Florida, United States
Spokane, Washington, United States
Gent, , Belgium
Woodville South, South Australia, Australia
Sarasota, Florida, United States
Denver, Colorado, United States
Tuebingen, , Germany
Wuerzburg, , Germany
Clearwater, Florida, United States
Freiburg, , Germany
Santander, Cantabria, Spain
Groningen, , Netherlands
Toronto, Ontario, Canada
Augusta, Georgia, United States
Paris, , France
Rotterdam, , Netherlands
Graz, , Austria
Graz, , Austria
Jackson, Tennessee, United States
Gwangju, , Korea, Republic Of
San Juan, , Puerto Rico
Merida, Badajoz, Spain
Guangzhou, Guangdong, China
Monroe, Louisiana, United States
Nanjing, Jiangsu, China
Chengdu, Sichuan, China
Beijing, Beijing, China
Changsha, Hunan, China
Paris, , France
Cannock, , United Kingdom
Nagasaki Shi, Nagasaki, Japan
Eagan, Minnesota, United States
Kuopio, , Finland
Santiago, Metropolitana, Chile
Sendai Shi, Miyagi, Japan
Seoul, , Korea, Republic Of
Xiamen, Fujian, China
Wolverhampton, West Midlands, United Kingdom
Hangzhou, Zhejiang, China
Antalya, , Turkey
Brescia, , Italy
Warszawa, , Poland
Seoul, , Korea, Republic Of
Bern, , Switzerland
Sapporo Shi, Hokkaido, Japan
Solna, , Sweden
Summit, New Jersey, United States
San Miguel De Tucuman, Tucuman, Argentina
Santa Monica, California, United States
Udine, , Italy
Grenoble, , France
Plano, Texas, United States
Wroclaw, , Poland
Gyula, , Hungary
Istanbul, , Turkey
Ankara, , Turkey
Valdivia, Los Rios, Chile
La Palma, California, United States
Kitakyushu Shi, Fukuoka, Japan
Rotterdam, Zuid Holland, Netherlands
Kaohsiung City, , Taiwan
Taoyuan City, , Taiwan
Napoli, , Italy
Yokohama, Kanagawa, Japan
Toyoake Shi, Aichi, Japan
Mineola, New York, United States
Sherbrooke, Quebec, Canada
Bydgoszcz, , Poland
Taipei City, , Taiwan
Shinjuku, Tokyo, Japan
Allen, Texas, United States
San Juan, , Puerto Rico
Allen, Texas, United States
San Juan, , Puerto Rico
Krakow, Malopolskie, Poland
Kfar Sava, , Israel
Paris, , France
Debrecen, , Hungary
Chengdu, Sichuan, China
Leon, Guanajuato, Mexico
Salisbury, North Carolina, United States
Warszawa, Mazowieckie, Poland
Cooper City, Florida, United States
Paris, , France
Nagoya Shi, Aichi, Japan
Hangzhou, Zhejiang, China
Warsaw, , Poland
Corvallis, Oregon, United States
Valdivia, Los Rios, Chile
Shenzhen, Guangdong, China
Xian, Shaanxi, China
Santiago De Compostela, , Spain
Sao Paulo, , Brazil
Guangzhou, Guangdong, China
Wenzhou, Zhejiang, China
Glostrup, , Denmark
Orleans, Centre, France
Le Havre Cedex, , France
Budapest, Ix, Válassz Egy Opciót…, Hungary
Budapest, , Hungary
Padua, , Italy
Nishinomiya Shi, Hyogo Ken, Japan
Kawasaki Shi, Kanagawa, Japan
Bunkyo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Shinjuku, Tokyo, Japan
Albuquerque, New Mexico, United States
Shenzhen, Guangdong, China
Zhengzhou, Henan, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Jesus Maria, Lima, Peru
Vancouver, British Columbia, Canada
Santiago, , Chile
Santiago, , Chile
Ningbo, Jiangsu, China
Budapest, Válassz Egy Opciót…, Hungary
Guadalajara, Jalisco, Mexico
Kaohsiung City, , Taiwan
Vina Del Mar, , Chile
Caba, Buenos Aires, Argentina
Luoyang, Henan, China
Aarhus, Region Midt, Denmark
Woodville South, South Australia, Australia
Leeuwarden, Friesland, Netherlands
Warsaw, , Poland
Wien, , Austria
Chuo Ku, Tokyo, Japan
Aalst, , Belgium
Porto Alegre, Rs, Brazil
Bogota, Cundinamarca, Colombia
Nishinomiya Shi, Hyogo, Japan
Meguro Ku, Tokyo, Japan
Taoyuan, , Taiwan
Trois Rivières, Quebec, Canada
Taiyuan, Shanxi, China
Wenzhou, Zhejiang, China
Kanazawa Shi, Ishikawa, Japan
Bunkyo Ku, Tokyo, Japan
Newcastle Upon Tyne, Tyne And Wear, United Kingdom
Baton Rouge, Louisiana, United States
Tuebingen, , Germany
Taiyuan, Shanxi, China
Bordeaux, , France
Brasov, , Romania
Sapporo, Hokkaido, Japan
Nedlands, Western Australia, Australia
Beijing, Beijing, China
Bydgoszcz, , Poland
Lisboa, , Portugal
Solna, , Sweden
San Francisco, California, United States
Corvallis, Oregon, United States
Caba, Buenos Aires, Argentina
Cordoba, General Paz, Argentina
Graz, , Austria
Changsha, Hunan, China
Hangzhou, Zhejiang, China
Bunkyo Ku, Tokyo, Japan
Wolverhampton, West Midlands, United Kingdom
Cannock, , United Kingdom
Skokie, Illinois, United States
Paris, , France
Hamburg, , Germany
Brasov, , Romania
Taichung, , Taiwan
Taoyuan City, , Taiwan
Baltimore, Maryland, United States
Quilmes, Buenos Aires, Argentina
Beijing Shi, Beijing, China
Nanchang, Jiangxi, China
Augusta, Georgia, United States
Hopkinsville, Kentucky, United States
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Quilmes, Buenos Aires, Argentina
Buenos Aires, , Argentina
City Of Buenos Aires, , Argentina
Cordoba, , Argentina
San Isidro, , Argentina
Gent, , Belgium
Vitoria, Es, Brazil
Juiz De Fora, Mg, Brazil
Belo Horizonte, Minas Gerais, Brazil
Sao Paulo, , Brazil
Uberlandia, , Brazil
Plovdiv, , Bulgaria
Toronto, Ontario, Canada
Valdivia, Los Rios, Chile
Valdivia, Los Rios, Chile
Santiago, Metropolitana, Chile
Puente Alto, Region Metropolitana, Chile
Santiago, Rm, Chile
Osorno, , Chile
Valparaíso, , Chile
Beijing, Beijing, China
Chongqing, Chongqing, China
Xiamen, Fujian, China
Wuhan, Hubei, China
Changsha, Hunan, China
Changsha, Hunan, China
Baotou Shi, Inner Mongolia, China
Hohhot, Inner Mongolia, China
Nanjing, Jiangsu, China
Ningbo, Jiangsu, China
Suzhou, Jiangsu, China
Jiujiang, Jiangxi, China
Nanchang, Jiangxi, China
Pingxiang, Jiangxi, China
Shanghai Shi, Shanghai Sheng, China
Shanghai, Shanghai, China
Shanghai, Shanghai, China
Urumqi, Xinjiang Sheng, China
Wenzhou, Zhejiang, China
Barranquilla, Atlantico, Colombia
Chia, Cundinamarca, Colombia
Helsinki, , Finland
Kuopio, , Finland
Turku, , Finland
Amiens, , France
Grenoble, , France
Le Kremlin Bictre, , France
Marseille, , France
Paris, , France
Munich, Bayern, Germany
Wurzburg, Bayern, Germany
Berlin, , Germany
Freiburg, , Germany
Athens, , Greece
Athina, , Greece
Larissa, , Greece
Gyula, , Hungary
Ramat Gan, Ia, Israel
Kfar Sava, , Israel
Brescia, , Italy
Milano, , Italy
Pisa, , Italy
Rome, , Italy
Rome, , Italy
Udine, , Italy
Toyoake Shi, Aichi, Japan
Kitakyushu Shi, Fukuoka, Japan
Sapporo Shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Nishinomiya Shi, Hyogo, Japan
Tsukuba City, Ibaraki, Japan
Kahoku Gun, Ishikawa, Japan
Yokohama, Kanagawa, Japan
Sendai Shi, Miyagi, Japan
Nagasaki Shi, Nagasaki, Japan
Sasebo, Nagasaki, Japan
Kurashiki, Okayama, Japan
Otsu, Shiga, Japan
Higashi Ku, Shizuoka, Japan
Shimotsugagun, Tochigi, Japan
Bunkyo Ku, Tokyo, Japan
Bunkyo Ku, Tokyo, Japan
Itabashi City, Tokyo, Japan
Meguro Ku, Tokyo, Japan
Shinagawa Ku, Tokyo, Japan
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Guadalajara, Jalisco, Mexico
Chihuahua, , Mexico
Mexico, , Mexico
Rotterdam, Zuid Holland, Netherlands
Groningen, , Netherlands
Santiago De Surco, Lima, Peru
Lima, , Peru
Lublin, Lubelskie, Poland
Warsaw, Mazowieckie, Poland
Wroclaw, Woj. Dolnoslaskie, Poland
Warszawa, Woj. Mazowieckie, Poland
Warszawa, Woj. Mazowieckie, Poland
Bydgoszcz, , Poland
Poznan, , Poland
Warsawa, , Poland
Warsaw, , Poland
Warszawa, , Poland
Wroclaw, , Poland
Lisbon, , Portugal
Iasi, , Romania
Santander, Cantabria, Spain
La Laguna, Santa Cruz De Tenerife, Spain
A Coruna, , Spain
Merida, , Spain
Sevilla, , Spain
Gotenburg, , Sweden
Basel, Baden Württemberg, Switzerland
Bern, , Switzerland
Southwest, , Switzerland
Taichung, , Taiwan
Taipei City, , Taiwan
Ankara, , Turkey
Ankara, , Turkey
Antalya, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Southampton, Hampshire, United Kingdom
Birmingham, , United Kingdom
Wien, , Austria
Sofia, , Bulgaria
Vina Del Mar, , Chile
Beijing, Beijing, China
Kurashiki, Okayama, Japan
Chuo Ku, Tokyo, Japan
Bucharest, , Romania
Cluj Napoca, , Romania
Kanazawa Shi, Ishikawa, Japan
San Isidro, Alabama, Argentina
Buenos Aires, , Argentina
Vitoria, Es, Brazil
Santiago, , Chile
Zhengzhou, Henan, China
Tsukuba City, Ibaraki, Japan
Itabashi City, Tokyo, Japan
Meguro Ku, Tokyo, Japan
Bydgoszcz, , Poland
Poznan, , Poland
Lisbon, , Portugal
Bucharest, , Romania
A Coruna, , Spain
Caba, Buenos Aires, Argentina
San Miguel De Tucuman, Tucuman, Argentina
Uberlandia, , Brazil
Santiago De Chlie, Region Metropolitana, Chile
Kawasaki Shi, Kanagawa, Japan
Sasebo, Nagasaki, Japan
Higashi Ku, Shizuoka, Japan
Shimotsugagun, Tochigi, Japan
Shinagawa Ku, Tokyo, Japan
Taichung, , Taiwan
City Of Buenos Aires, , Argentina
Juiz De Fora, Mg, Brazil
Porto Alegre, Rs, Brazil
Santiago De Chlie, Region Metropolitana, Chile
Paris, , France
Ramat Gan, Ia, Israel
Meguro Ku, Tokyo, Japan
Seongdong Gu, Seoul, Korea, Republic Of
Lisboa, , Portugal
Merida, Badajoz, Spain
La Laguna, Santa Cruz De Tenerife, Spain
Yenimahalle, Ankara, Turkey
San Isidro, Alabama, Argentina
Quilmes, Buenos Aires, Argentina
Vitoria, Es, Brazil
Sao Paulo, Sp, Brazil
Vancouver, British Columbia, Canada
Santiago, Metropolitana, Chile
Shanghai Shi, Shanghai Sheng, China
Le Havre Cedex, , France
Le Kremlin Bictre, , France
Napoli, , Italy
Pisa, , Italy
Mexico, Distrito Federal, Mexico
Lublin, , Poland
Yenimahalle, Ankara, Turkey
Southampton, Hampshire, United Kingdom
Caba, , Argentina
Plovdiv, , Bulgaria
Bogota D.C, , Colombia
Athens, , Greece
Rotterdam, Zuid Holland, Netherlands
Wroclaw, , Poland
Birmingham, , United Kingdom
Caba, , Argentina
Santiago, Providencia, Chile
Chica, Cundinamarca, Colombia
Hamamatsu, Shizuoka, Japan
Otsu, Shiga, Japan
La Palma, California, United States
Larissa, , Greece
Rome, , Italy
Gotenburg, , Sweden
Amiens, , France
Southwest, , Switzerland
Wuerzburg, , Germany
Sarasota, Florida, United States
Belo Horizonte, Minas Gerais, Brazil
Munich, Bayern, Germany
Cordoba, , Argentina
Berlin, , Germany
Bunkyo Ku, Tokyo, Japan
Lisboa, , Portugal
Sofia, , Bulgaria
San Juan, , Puerto Rico
San Francisco, California, United States
Cluj Napoca, Cluj, Romania
Bucharest, , Romania
Salisbury, North Carolina, United States
The Woodlands, Texas, United States
Mexico, Distrito Federal, Mexico
Coconut Creek, Florida, United States
Guadalajara, Jalisco, Mexico
Fullerton, California, United States
Cooper City, Florida, United States
Katy, Texas, United States
Clearwater, Florida, United States
Cooper City, Florida, United States
Lawrenceville, Georgia, United States
Summit, New Jersey, United States
Allen, Texas, United States
Vina Del Mar, Valparaiso, Chile
Taiyuan, Shan1xi, China
Turku, , Finland
Seoul, , Korea, Republic Of
Leon, Guanajuato, Mexico
Warszawa, , Poland
Jackson, Tennessee, United States
Plano, Texas, United States
Valdivia, Los Lagos, Chile
Buenos Aires, , Argentina
Hohhot, Inner Mongolia, China
Suzhou, Jiangsu, China
Lima, , Peru
Monroe, Louisiana, United States
Warszawa, Woj. Mazowieckie, Poland
Taiyuan, , China
Budapest, Ix, , Hungary
Basel, , Switzerland
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported