A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
NCT ID: NCT05946941
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
756 participants
INTERVENTIONAL
2023-09-11
2028-11-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Deucravacitinib, Dose 1
Deucravacitinib
Specified dose on specified days
Deucravacitinib, Dose 2
Deucravacitinib
Specified dose on specified days
Placebo, followed by Deucravacitinib Dose 1 or Dose 2
Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 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 - 0162
Pingxiang, Jiangxi, China
Local Institution - 0101
Xi'an, Shaanxi, China
Local Institution - 0182
Taiyuan, Shan1xi, China
Local Institution - 0102
Shanghai, Shanghai Municipality, China
Local Institution - 0151
Shanghai, Shanghai Municipality, China
Local Institution - 0157
Shanghai Shi, Shanghai Sheng, China
Local Institution - 0178
Chengdu, Sichuan, China
Local Institution - 0179
Ürümqi, Xinjiang Sheng, China
Local Institution - 0181
Hangzhou, Zhejiang, China
Local Institution - 0228
Fullerton, California, United States
Local Institution - 0222
La Palma, California, United States
Local Institution - 0218
San Francisco, California, United States
Local Institution - 0203
Santa Monica, California, United States
Local Institution - 0067
Denver, Colorado, United States
Local Institution - 0049
Clearwater, Florida, United States
GNP Research
Cooper City, Florida, United States
Local Institution - 0223
Sarasota, Florida, United States
Local Institution - 0140
Augusta, Georgia, United States
Local Institution - 0229
Lawrenceville, Georgia, United States
Local Institution - 0174
Skokie, Illinois, United States
Local Institution - 0016
Kansas City, Kansas, United States
Local Institution - 0123
Hopkinsville, Kentucky, United States
Local Institution - 0017
Baton Rouge, Louisiana, United States
Local Institution - 0125
Monroe, Louisiana, United States
Local Institution - 0187
Baltimore, Maryland, United States
Local Institution - 0173
Boston, Massachusetts, United States
Local Institution - 0131
Eagan, Minnesota, United States
Local Institution - 0138
Summit, New Jersey, United States
Local Institution - 0009
Albuquerque, New Mexico, United States
Local Institution - 0184
Mineola, New York, United States
Local Institution - 0224
Salisbury, North Carolina, United States
Local Institution - 0132
Corvallis, Oregon, United States
Local Institution - 0130
Duncansville, Pennsylvania, United States
Local Institution - 0022
Jackson, Tennessee, United States
Local Institution - 0144
Allen, Texas, United States
Local Institution - 0227
Katy, Texas, United States
Local Institution - 0175
Plano, Texas, United States
Local Institution - 0225
The Woodlands, Texas, United States
Local Institution - 0133
Seattle, Washington, United States
Local Institution - 0189
Spokane, Washington, United States
Local Institution - 0050
San Isidro, Alabama, Argentina
Local Institution - 0100
CABA, Buenos Aires, Argentina
Local Institution - 0019
Quilmes, Buenos Aires, Argentina
Local Institution - 0026
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0003
Buenos Aires, , Argentina
Local Institution - 0058
Buenos Aires, , Argentina
Local Institution - 0137
CABA, , Argentina
Local Institution - 0109
City of Buenos Aires, , Argentina
Local Institution - 0061
Córdoba, , Argentina
Local Institution - 0039
Córdoba, , Argentina
Local Institution - 0120
Woodville South, South Australia, Australia
Local Institution - 0165
Nedlands, Western Australia, Australia
Local Institution - 0117
Graz, , Austria
Local Institution - 0087
Vienna, , Austria
Local Institution - 0183
Aalst, , Belgium
Local Institution - 0172
Ghent, , Belgium
Local Institution - 0170
Vitória, Espírito Santo, Brazil
Local Institution - 0106
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0091
Juiz de Fora, Minas Gerais, Brazil
Local Institution - 0055
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0018
São Paulo, São Paulo, Brazil
Local Institution - 0111
Uberlândia, , Brazil
Local Institution - 0008
Plovdiv, , Bulgaria
Local Institution - 0221
Sofia, , Bulgaria
Local Institution - 0134
Vancouver, British Columbia, Canada
Local Institution - 0063
Toronto, Ontario, Canada
Local Institution - 0004
Sherbrooke, Quebec, Canada
Local Institution - 0056
Trois-Rivières, Quebec, Canada
Local Institution - 0103
Valdivia, Los Ríos Region, Chile
Local Institution - 0136
Santiago, Providencia, Chile
Local Institution - 0032
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 0097
Santiago, Santiago Metropolitan, Chile
Local Institution - 0015
Santiago de Chlie, Santiago Metropolitan, Chile
Local Institution - 0099
Osorno, , Chile
Local Institution - 0121
Santiago, , Chile
Local Institution - 0216
Santiago, , Chile
Local Institution - 0200
Valdivia, , Chile
Local Institution - 0153
Beijing, Beijing Municipality, China
Local Institution - 0156
Beijing, Beijing Municipality, China
Local Institution - 0160
Beijing, Beijing Municipality, China
Local Institution - 0096
Chongqing, Chongqing Municipality, China
Local Institution - 0155
Xiamen, Fujian, China
Local Institution - 0095
Guangzhou, Guangdong, China
Local Institution - 0212
Shenzhen, Guangdong, China
Local Institution - 0180
Luoyang, Henan, China
Local Institution - 0214
Zhengzhou, Henan, China
Local Institution - 0149
Wuhan, Hubei, China
Local Institution - 0094
Changsha, Hunan, China
Local Institution - 0158
Changsha, Hunan, China
Local Institution - 0098
Baotou Shi, Inner Mongolia, China
Local Institution - 0150
Hohhot, Inner Mongolia, China
Local Institution - 0215
Nanjing, Jiangsu, China
Local Institution - 0159
Nanjing, Jiangsu, China
Local Institution - 0154
Suzhou, Jiangsu, China
Local Institution - 0163
Jiujiang, Jiangxi, China
Local Institution - 0177
Nanchang, Jiangxi, China
Local Institution - 0213
Nanchang, Jiangxi, China
Local Institution - 0152
Hangzhou, Zhejiang, China
Local Institution - 0161
Ningbo, Zhejiang, China
Local Institution - 0093
Wenzhou, Zhejiang, China
Local Institution - 0168
Barranquilla, Atlántico, 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 Municipality, , Denmark
Local Institution - 0199
Helsinki, , Finland
Local Institution - 0135
Kuopio, , Finland
Local Institution - 0119
Turku, , Finland
Local Institution - 0072
Orléans, Centre-Val de Loire, France
Local Institution - 0005
Amiens, , France
Local Institution - 0073
Bordeaux, , France
Local Institution - 0070
Grenoble, , France
Local Institution - 0074
Le Havre, , France
Local Institution - 0167
Le Kremlin-Bictre, , France
Local Institution - 0078
Marseille, , France
Local Institution - 0025
Paris, , France
Local Institution - 0107
Paris, , France
Local Institution - 0057
Paris, , France
Local Institution - 0079
Munich, Bavaria, Germany
Local Institution - 0092
Berlin, , Germany
Local Institution - 0031
Freiburg im Breisgau, , Germany
Local Institution - 0033
Hamburg, , Germany
Local Institution - 0075
Tübingen, , Germany
Local Institution - 0051
Würzburg, , Germany
Local Institution - 0052
Athens, , Greece
Local Institution - 0077
Athens, , Greece
Local Institution - 0108
Larissa, , Greece
Local Institution - 0115
Budapest, IX, Válassz Egy Opciót…, Hungary
Local Institution - 0113
Budapest, , Hungary
Local Institution - 0083
Debrecen, , Hungary
Local Institution - 0090
Gyula, , Hungary
Local Institution - 0145
Ramat Gan, IA, Israel
Local Institution - 0142
Kfar Saba, , Israel
Local Institution - 0065
Brescia, , Italy
Local Institution - 0029
Milan, , Italy
Local Institution - 0124
Napoli, , Italy
Local Institution - 0082
Padua, , Italy
Local Institution - 0128
Pisa, , Italy
Local Institution - 0069
Rome, , Italy
Local Institution - 0062
Rome, , Italy
Local Institution - 0081
Udine, , Italy
Local Institution - 0146
Nagoya, Aichi-ken, Japan
Local Institution - 0205
Toyoake-shi, Aichi-ken, Japan
Local Institution - 0148
Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0122
Sapporo, Hokkaido, Japan
Local Institution - 0188
Sapporo, Hokkaido, Japan
Local Institution - 0211
Nishinomiya-shi, Hyōgo, Japan
Local Institution - 0193
Tsukuba, Ibaraki, Japan
Local Institution - 0202
Kahoku-gun, Ishikawa-ken, Japan
Local Institution - 0118
Kanazawa, Ishikawa-ken, Japan
Local Institution - 0206
Kawasaki-shi, Kanagawa, Japan
Local Institution - 0191
Yokohama, Kanagawa, Japan
Local Institution - 0139
Sendai, Miyagi, Japan
Local Institution - 0147
Nagasaki, Nagasaki, Japan
Local Institution - 0129
Sasebo, Nagasaki, Japan
Local Institution - 0207
Kurashiki, Okayama-ken, Japan
Local Institution - 0198
Ōtsu, Shiga, Japan
Local Institution - 0194
Hamamatsu, Shizuoka, Japan
Local Institution - 0195
Shimotsugagun, Tochigi, Japan
Local Institution - 0210
Bunkyo-ku, Tokyo, Japan
Local Institution - 0196
Bunkyo-ku, Tokyo, Japan
Local Institution - 0190
Chuo-ku, Tokyo, Japan
Local Institution - 0201
Meguro-ku, Tokyo, Japan
Local Institution - 0208
Meguro-ku, Tokyo, Japan
Local Institution - 0204
Shinagawa-ku, Tokyo, Japan
Local Institution - 0197
Shinjuku, Tokyo, Japan
Local Institution - 0192
tabashi City, Tokyo, Japan
Local Institution - 0020
León, Guanajuato, Mexico
Local Institution - 0023
Guadalajara, Jalisco, Mexico
Local Institution - 0048
Guadalajara, Jalisco, Mexico
Local Institution - 0169
Mexico City, Mexico City, Mexico
Local Institution - 0021
Chihuahua City, , Mexico
Local Institution - 0046
Leeuwarden, Provincie Friesland, Netherlands
Local Institution - 0001
Groningen, , Netherlands
Local Institution - 0105
Rotterdam, , Netherlands
Local Institution - 0047
Jesus Maria, Lima region, Peru
Local Institution - 0011
Santiago de Surco, Lima region, Peru
Local Institution - 0171
Lima, , Peru
Local Institution - 0084
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0054
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0141
Warsaw, Woj. Mazowieckie, Poland
Local Institution - 0010
Warsaw, Woj. Mazowieckie, Poland
Local Institution - 0024
Bydgoszcz, , Poland
Local Institution - 0085
Bydgoszcz, , Poland
Local Institution - 0040
Lublin, , Poland
Local Institution - 0089
Poznan, , Poland
Local Institution - 0080
Warsaw, , Poland
Local Institution - 0076
Warsaw, , Poland
Local Institution - 0185
Warsaw, , Poland
Local Institution - 0064
Wroclaw, , Poland
Local Institution - 0036
Wroclaw, , Poland
Local Institution - 0028
Lisbon, , Portugal
Local Institution - 0014
Lisbon, , Portugal
Local Institution - 0143
San Juan, , Puerto Rico
Local Institution - 0127
San Juan, , Puerto Rico
Local Institution - 0220
Cluj-Napoca, Cluj, Romania
Local Institution - 0041
Brasov, , Romania
Local Institution - 0219
Bucharest, , Romania
Local Institution - 0104
Iași, , Romania
Local Institution - 0110
Seongdong-gu, Seoul, South Korea
Local Institution - 0042
Gwangju, , South Korea
Local Institution - 0126
Seoul, , South Korea
Local Institution - 0209
Seoul, , South Korea
Local Institution - 0038
Mérida, Badajoz, Spain
Local Institution - 0059
Santander, Cantabria, Spain
Local Institution - 0114
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Local Institution - 0112
A Coruña, , Spain
Local Institution - 0068
Santiago de Compostela, , Spain
Local Institution - 0071
Seville, , Spain
Local Institution - 0166
Gothenburg, , Sweden
Local Institution - 0164
Solna, , Sweden
Local Institution - 0066
Basel, Baden-Württemberg, Switzerland
Local Institution - 0013
Bern, , Switzerland
Local Institution - 0034
Southwest, , Switzerland
Local Institution - 0116
Kaohsiung City, , Taiwan
Local Institution - 0012
Taichung, , Taiwan
Local Institution - 0002
Taichung, , Taiwan
Local Institution - 0027
Taipei, , Taiwan
Local Institution - 0045
Taoyuan, , Taiwan
Local Institution - 0035
Yenimahalle, Ankara, Turkey (Türkiye)
Local Institution - 0088
Ankara, , Turkey (Türkiye)
Local Institution - 0007
Antalya, , Turkey (Türkiye)
Local Institution - 0086
Istanbul, , Turkey (Türkiye)
Local Institution - 0044
Istanbul, , Turkey (Türkiye)
Local Institution - 0176
Southampton, Hampshire, United Kingdom
Local Institution - 0053
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Local Institution - 0217
Wolverhampton, West Midlands, United Kingdom
Local Institution - 0030
Birmingham, , United Kingdom
Local Institution - 0060
Cannock, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Mark Jaffee, Site 0226
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2023-503327-26
Identifier Type: REGISTRY
Identifier Source: secondary_id
U111-1289-6072
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM011-1069
Identifier Type: -
Identifier Source: org_study_id