A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
- Registration Number
- NCT05946941
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 756
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo, followed by Deucravacitinib Dose 1 or Dose 2 Placebo - Placebo, followed by Deucravacitinib Dose 1 or Dose 2 Deucravacitinib - Deucravacitinib, Dose 1 Deucravacitinib - Deucravacitinib, Dose 2 Deucravacitinib -
- Primary Outcome Measures
Name Time Method Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 Baseline, Week 52
- Secondary Outcome Measures
Name Time Method Change from baseline in joint/ muscle pain NRS at Week 52 Baseline, Week 52 Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52 Baseline, Week 52 Number of participants with ESSDAI < 5 at Week 52 Baseline, Week 52 Change from baseline in stimulated whole salivary flow (SWSF) at Week 52 Baseline, Week 52 Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52 Baseline, Week 52 Change from baseline in oral dryness NRS at Week 52 Baseline, Week 52 Number of participants with electrocardiogram (ECG) abnormalities Up to Week 156 Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52 Baseline, Week 52 Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52 Baseline, Week 52 Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52 Baseline, Week 52 Number of participants with AEs leading to discontinuation of treatment and study discontinuation Up to Week 160 Number of participants with clinical laboratory abnormalities Up to Week 160 Change from baseline in ESSDAI at Week 24 Baseline, Week 24 Change from baseline in physician global assessment (PhGA) at Week 52 Baseline, Week 52 Number of participants with an increase of Schirmer's test ≥ 5 mm if abnormal baseline or no change of Schirmer's test to abnormal if baseline is normal Baseline, Week 52 Number of participants with adverse events (AEs) Up to Week 160 Number of participants with serious AEs (SAEs) Up to Week 160 Number of participants with AEs of special interest (AESIs) Up to Week 160 Number of participants with vital sign abnormalities Up to Week 160
Trial Locations
- Locations (229)
Local Institution - 0062
🇮🇹Rome, Italy
Santa Maria della Misericordia
🇮🇹Udine, Italy
Local Institution - 0225
🇺🇸The Woodlands, Texas, United States
University Multiprofile Hospital for Active Treatment Kaspela EOOD
🇧🇬Plovdiv, Bulgaria
Local Institution - 0052
🇬🇷Athina, Greece
Local Institution - 0228
🇺🇸Fullerton, California, United States
Arthritis and Osteoporosis Medical Center
🇺🇸La Palma, California, United States
UCSF Univ of California San Francisco
🇺🇸San Francisco, California, United States
Providence St. John's Health Center
🇺🇸Santa Monica, California, United States
Denver Arthritis Clinic
🇺🇸Denver, Colorado, United States
Clinical Research of West Florida; Inc
🇺🇸Clearwater, Florida, United States
Local Institution - 0226
🇺🇸Cooper City, Florida, United States
Sarasota Arthritis Center
🇺🇸Sarasota, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Local Institution - 0229
🇺🇸Lawrenceville, Georgia, United States
Clinic of Robert Hozman/Clinical Investigation Specialists Inc.
🇺🇸Skokie, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Local Institution - 0123
🇺🇸Hopkinsville, Kentucky, United States
Ochsner Health Center - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Arthritis and Diabetes Clinic
🇺🇸Monroe, Louisiana, United States
Johns Hopkins Medicine - Jerome L. Greene Sjogrens Syndrome Center
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Saint Paul Rheumatology
🇺🇸Eagan, Minnesota, United States
Institute for Rheumatic & Autoimmune Diseases; Overlook Medical Center
🇺🇸Summit, New Jersey, United States
New Mexico Clinical Research Osteoporosis
🇺🇸Albuquerque, New Mexico, United States
NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
Local Institution - 0224
🇺🇸Salisbury, North Carolina, United States
Local Institution - 0132
🇺🇸Corvallis, Oregon, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Local Institution - 0022
🇺🇸Jackson, Tennessee, United States
Arthritis & Rheumatology Research Institute; PLLC
🇺🇸Allen, Texas, United States
Local Institution - 0227
🇺🇸Katy, Texas, United States
Local Institution - 0175
🇺🇸Plano, Texas, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Arthritis Northwest
🇺🇸Spokane, Washington, United States
IMAC SI
🇦🇷San Isidro, Alabama, Argentina
Fundacion Respirar
🇦🇷Caba, Buenos Aires, Argentina
Iro Research
🇦🇷Caba, Buenos Aires, Argentina
CER Instituto Medico
🇦🇷Quilmes, Buenos Aires, Argentina
Centro de Investigaciones Medicas Tucuman
🇦🇷San Miguel de Tucuman, Tucuman, Argentina
Local Institution - 0058
🇦🇷Buenos Aires, Argentina
IME Instituto medico Especializado
🇦🇷Caba, Argentina
Centro Barrio Parque - Swiss Medical
🇦🇷City of Buenos Aires, Argentina
Consultora Integral de Salud SRL
🇦🇷Cordoba, Argentina
Local Institution - 0039
🇦🇷Cordoba, Argentina
The Queen Elizabeth Hospital
🇦🇺Woodville South, South Australia, Australia
Local Institution - 0165
🇦🇺Nedlands, Western Australia, Australia
Medical University of Graz
🇦🇹Graz, Austria
Local Institution - 0087
🇦🇹Wien, Austria
Local Institution - 0183
🇧🇪Aalst, Belgium
UZ Gent
🇧🇪Gent, Belgium
Hospital Universitario Cassiano Antonio Moraes
🇧🇷Vitoria, ES, Brazil
Cmip-Centro Mineiro de Pesquisa
🇧🇷Juiz de Fora, MG, Brazil
Universidade Federal de Minas Gerais (UFMG) - Faculdade de Medicina
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Hospital Moinhos de Vento
🇧🇷Porto Alegre, RS, Brazil
CEPIC Centro Paulista de Investigacao Clinica
🇧🇷Sao Paulo, SP, Brazil
Universidade Federal de Uberlandia (UFU) - Campus Santa Monica - Centro de Pesquisa Clinica
🇧🇷Uberlandia, Brazil
ARENSIA Research Clinic MBAL Sveta Sofia
🇧🇬Sofia, Bulgaria
Sjogren's Clinic at the Mary Pack Arthritis Center
🇨🇦Vancouver, British Columbia, Canada
University Health Network - Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
Diex Recherche Sherbrooke
🇨🇦Sherbrooke, Quebec, Canada
Centre De Recherche Musculo-Squelettique
🇨🇦Trois Rivières, Quebec, Canada
Clinical Research Chile SpA
🇨🇱Valdivia, LOS Lagos, Chile
Local Institution - 0103
🇨🇱Valdivia, Los Rios, Chile
BioMedica Research Group
🇨🇱Santiago, Metropolitana, Chile
Centro de Estudios Reumatologicos
🇨🇱Santiago, Providencia, Chile
Hospital Sotero del Rio
🇨🇱Santiago De Chlie, Region Metropolitana, Chile
CIERI
🇨🇱Vina Del Mar, Valparaiso, Chile
Local Institution - 0099
🇨🇱Osorno, Chile
Estudios Clinicos GyC
🇨🇱Santiago, Chile
Local Institution - 0121
🇨🇱Santiago, Chile
Peking University First Hospital (Beida Hospital) (No.1 Hospital Affiliated to Beijing Medical University)
🇨🇳Beijing Shi, Beijing, China
Peking University People's Hospital - Institute of Rheumatology and Immunology
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Local Institution - 0096
🇨🇳Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
Shenzhen Peoples Hospital
🇨🇳Shenzhen, Guangdong, China
Local Institution - 0180
🇨🇳Luoyang, Henan, China
1st Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Karolinska University Hospital
🇸🇪Solna, Sweden
Tongji Hospital affiliated to Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Hunan Province People's Hospital
🇨🇳Changsha, Hunan, China
Local Institution - 0098
🇨🇳Baotou Shi, Inner Mongolia, China
Inner Mongolia Medical University IMMU - The Affiliated Hospital
🇨🇳Hohhot, Inner Mongolia, China
Nanjing Drum Tower hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
🇨🇳Nanjing, Jiangsu, China
Ningbo First Hospital
🇨🇳Ningbo, Jiangsu, China
1st affiliated Hospital of Suzhou University
🇨🇳Suzhou, Jiangsu, China
Local Institution - 0163
🇨🇳Jiujiang, Jiangxi, China
1st Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jiangxi Provincial Peoples Hospital
🇨🇳Nanchang, Jiangxi, China
Pingxiang Peoples Hospital
🇨🇳Pingxiang, Jiangxi, China
The First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xian, Shaanxi, China
Shanxi Bethune Hospital;Shanxi Academy of Medical Sciences
🇨🇳Taiyuan, Shan1xi, China
Shanghai 9th Peoples Hospital
🇨🇳Shanghai Shi, Shanghai Sheng, China
Hopital Cochin
🇫🇷Paris, France
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine -Shanghai Institute of Rheumatology
🇨🇳Shanghai, Shanghai, China
Tongji University - Tongji Hospital
🇨🇳Shanghai, Shanghai, China
West China Hospital Sichuan University
🇨🇳Chengdu, Sichuan, China
Xinjiang Uygur Autonomous Region People's Hospital
🇨🇳Urumqi, Xinjiang Sheng, China
The First Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Wenzhou Medical University (WMU) - The First Affiliated Hospital
🇨🇳Wenzhou, Zhejiang, China
Local Institution - 0168
🇨🇴Barranquilla, Atlantico, Colombia
Local Institution - 0043
🇨🇴Chica, Cundinamarca, Colombia
Local Institution - 0037
🇨🇴Bogota D.C, Colombia
Local Institution - 0186
🇩🇰Aarhus, Region Midt, Denmark
Local Institution - 0006
🇩🇰Glostrup, Denmark
Local Institution - 0199
🇫🇮Helsinki, Finland
Local Institution - 0135
🇫🇮Kuopio, Finland
Local Institution - 0119
🇫🇮Turku, Finland
Hopital de la Pitie Salpetriere
🇫🇷Paris, Cedex 13, France
Local Institution - 0072
🇫🇷Orleans, Centre, France
CHU Amiens-Picardie - Site Nord Hopital Nord
🇫🇷Amiens, France
CHU de Bordeaux - Hopital Saint-Andre
🇫🇷Bordeaux, France
CHU Grenoble Alpes
🇫🇷Grenoble, France
Groupe Hospitalier du Havre (GHH) - Hopital Jacques Monod
🇫🇷Le Havre Cedex, France
CHU Hpital de Bicetre Universit Paris 11
🇫🇷Le Kremlin-Bictre, France
Local Institution - 0078
🇫🇷Marseille, France
Hopital Saint Antoine
🇫🇷Paris, France
Klinikum der Universitaet Muenchen LMU
🇩🇪Munich, Bayern, Germany
Charite University Hospitals
🇩🇪Berlin, Germany
University Hospital Freiburg
🇩🇪Freiburg, Germany
Hamburger Rheuma Forschungszentrum 2
🇩🇪Hamburg, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
National and Kapodistrian University of Athens NKUA - Laiko General Hospital
🇬🇷Athens, Greece
University of Thessaly - General University Hospital of Larissa UHL - Rheumatology Clinic
🇬🇷Larissa, Greece
Local Institution - 0115
🇭🇺Budapest, IX, Válassz Egy Opciót…, Hungary
Local Institution - 0113
🇭🇺Budapest, Hungary
Debreceni Egyetem - Orvos es Egeszsegtudomanyi Centrum (DEOEC) (University of Debrecen Medical and Health Science Center)
🇭🇺Debrecen, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
🇭🇺Gyula, Hungary
Sheba Medical Center
🇮🇱Ramat Gan, IA, Israel
Meir Medical Center
🇮🇱Kfar Sava, Israel
Asst Spedali Civili Di Brescia
🇮🇹Brescia, Italy
Local Institution - 0029
🇮🇹Milano, Italy
Università degli Studi della Campania Luigi Vanvitelli Napoli
🇮🇹Napoli, Italy
Local Institution - 0082
🇮🇹Padua, Italy
AOU Pisana
🇮🇹Pisa, Italy
Campus Biomedico University
🇮🇹Rome, Italy
Kojunkai Daido Clinic
🇯🇵Nagoya-shi, Aichi, Japan
Fujita Health University Hospital
🇯🇵Toyoake-shi, Aichi, Japan
Hospital of the University of Occupational and Environmental Health
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Hokkaido University Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Sapporo Medical University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Medical University Hospital
🇯🇵Nishinomiya-shi, Hyogo, Japan
Tsukuba University Hospital
🇯🇵Tsukuba City, Ibaraki, Japan
Kanazawa Medical University Hospital
🇯🇵Kahoku-gun, Ishikawa, Japan
Kanazawa University Hospital
🇯🇵Kanazawa-shi, Ishikawa, Japan
St.Marianna University Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
National Hospital Organization Yokohama Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Nagasaki University Hospital
🇯🇵Nagasaki-Shi, Nagasaki, Japan
Sasebo Chuo Hospital
🇯🇵Sasebo, Nagasaki, Japan
Kurashiki Medical Clinic
🇯🇵Kurashiki, Okayama, Japan
Shiga University of Medical Science Hospital
🇯🇵Otsu, Shiga, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
Dokkyo Medical University Hospital
🇯🇵Shimotsugagun, Tochigi, Japan
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Institute of Science Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
St. Luke's International Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Nihon University Itabashi Hospital
🇯🇵Itabashi City, Tokyo, Japan
National Hospital Organization Tokyo Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Toho University Ohashi Medical Center
🇯🇵Meguro-ku, Tokyo, Japan
Showa University East Hospital
🇯🇵Shinagawa-ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku, Tokyo, Japan
Hanyang University Seoul Hospital
🇰🇷Seongdong-gu, Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
The Catholic University of Korea; Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Korea, Republic of
CINTRE - Centro de investigacion y tratamiento reumatologico, S.C.
🇲🇽Mexico, Distrito Federal, Mexico
Consultorio Medico de Reumatologia
🇲🇽Leon, Guanajuato, Mexico
Local Institution - 0023
🇲🇽Guadalajara, Jalisco, Mexico
Centro de Estudios de Investigacion Basica y Clinica S.C.
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0021
🇲🇽Chihuahua, Mexico
Local Institution - 0046
🇳🇱Leeuwarden, Friesland, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Zuid-Holland, Netherlands
Universitair Medisch Centrum Groningen
🇳🇱Groningen, Netherlands
Local Institution - 0047
🇵🇪Jesus Maria, Lima, Peru
Local Institution - 0011
🇵🇪Santiago de Surco, Lima, Peru
Local Institution - 0171
🇵🇪Lima, Peru
Centrum Medyczne PLEJADY
🇵🇱Krakow, Malopolskie, Poland
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
Rheuma Medicus
🇵🇱Warszawa, Woj. Mazowieckie, Poland
Local Institution - 0010
🇵🇱Warszawa, Woj. Mazowieckie, Poland
MICS Centrum Medyczne Bydgoszcz
🇵🇱Bydgoszcz, Poland
Szpital Uniwersytecki nr 2 im.dr. Jana Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Etg Network
🇵🇱Lublin, Poland
Med-Polonia Sp. zo.o.
🇵🇱Poznan, Poland
Reuma Park Warszawa
🇵🇱Warsawa, Poland
FutureMeds Targowek
🇵🇱Warsaw, Poland
Narodowy Instytut Geriatrii; Reumatologii i Rehabilitacji
🇵🇱Warszawa, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o.
🇵🇱Wroclaw, Poland
Dolnoslaski Szpital Specjalistyczny im. Tadeusza Marciniaka
🇵🇱Wroclaw, Poland
Instituto Portugues de Reumatologia
🇵🇹Lisboa, Portugal
Centro Hospitalar Universitario Lisboa Norte E.P.E. (CHULN) - Hospital de Santa Maria
🇵🇹Lisboa, Portugal
GCM Medical Group, PSC - Hato Rey Site-Hato Rey
🇵🇷San Juan, Puerto Rico
Local Institution - 0127
🇵🇷San Juan, Puerto Rico
ARENSIA Research Clinic Emergency County Hospital
🇷🇴Cluj-Napoca, Cluj, Romania
CMDTA Neomed SRL
🇷🇴Brasov, Romania
Arensia Research Clinic
🇷🇴Bucharest, Romania
Local Institution - 0104
🇷🇴Iasi, Romania
Hospital de Merida
🇪🇸Merida, Badajoz, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario De Canarias - San Cristbal de La Laguna
🇪🇸La Laguna, Santa Cruz De Tenerife, Spain
Local Institution - 0112
🇪🇸A Coruna, Spain
Clinica GAIAS Santiago
🇪🇸Santiago De Compostela, Spain
Hospital Infantaluisa
🇪🇸Sevilla, Spain
Sahlgrenska University Hospital
🇸🇪Gotenburg, Sweden
Local Institution - 0066
🇨🇭Basel, Baden-Württemberg, Switzerland
Insel Gruppe AG
🇨🇭Bern, Switzerland
Kantonsspital St. Gallen
🇨🇭Southwest, Switzerland
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung City, Taiwan
China Medical University Hospital CMUH
🇨🇳Taichung, Taiwan
Taichung Veterans General Hospital (VGHTC)
🇨🇳Taichung, Taiwan
National Taiwan University Hospital NTUH
🇨🇳Taipei City, Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan City, Taiwan
Gazi University Hospital
🇹🇷Yenimahalle, Ankara, Turkey
Hacettepe University School Of Medicine
🇹🇷Ankara, Turkey
Akdeniz University Medical Faculty
🇹🇷Antalya, Turkey
Local Institution - 0086
🇹🇷Istanbul, Turkey
Istanbul University Cerrahpasa Medical School
🇹🇷Istanbul, Turkey
Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, Hampshire, United Kingdom
Local Institution - 0053
🇬🇧Newcastle Upon Tyne, Tyne And Wear, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, West Midlands, United Kingdom
University of Birmingham - Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Cannock Chase Hospital
🇬🇧Cannock, United Kingdom