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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503327-26 | Registry Identifier | EU Clinical Trial Number | |
| U111-1289-6072 | Registry Identifier | WHO |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deucravacitinib, Dose 1 | Experimental |
| |
| Deucravacitinib, Dose 2 | Experimental |
| |
| Placebo, followed by Deucravacitinib Dose 1 or Dose 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 | Baseline, Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52 | Baseline, Week 52 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0228 | Fullerton | California | 92835 | United States | ||
| Local Institution - 0222 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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|
| Placebo | Other | Specified dose on specified days |
|
| Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52 | Baseline, Week 52 |
| Number of participants with ESSDAI < 5 at Week 52 | Baseline, Week 52 |
| Change from baseline in ESSDAI at Week 24 | Baseline, Week 24 |
| Change from baseline in stimulated whole salivary flow (SWSF) at Week 52 | Baseline, Week 52 |
| Change from baseline in physician global assessment (PhGA) at Week 52 | Baseline, Week 52 |
| Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue 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 |
| Change from baseline in joint/ muscle pain NRS 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 leading to discontinuation of treatment and study discontinuation | Up to Week 160 |
| Number of participants with AEs of special interest (AESIs) | Up to Week 160 |
| Number of participants with clinical laboratory abnormalities | Up to Week 160 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Week 156 |
| Number of participants with vital sign abnormalities | Up to Week 160 |
| La Palma |
| California |
| 90623 |
| United States |
| Local Institution - 0218 | San Francisco | California | 94143 | United States |
| Local Institution - 0203 | Santa Monica | California | 90404 | United States |
| Local Institution - 0067 | Denver | Colorado | 80230 | United States |
| Local Institution - 0049 | Clearwater | Florida | 33765 | United States |
| Local Institution - 0226 | Cooper City | Florida | 33024 | United States |
| Local Institution - 0223 | Sarasota | Florida | 34239 | United States |
| Local Institution - 0140 | Augusta | Georgia | 30912 | United States |
| Local Institution - 0229 | Lawrenceville | Georgia | 30046 | United States |
| Local Institution - 0174 | Skokie | Illinois | 60076 | United States |
| Local Institution - 0016 | Kansas City | Kansas | 66160 | United States |
| Local Institution - 0017 | Baton Rouge | Louisiana | 70836 | United States |
| Local Institution - 0125 | Monroe | Louisiana | 71203 | United States |
| Local Institution - 0187 | Baltimore | Maryland | 21224-2746 | United States |
| Local Institution - 0173 | Boston | Massachusetts | 02111 | United States |
| Local Institution - 0131 | Eagan | Minnesota | 55123 | United States |
| Local Institution - 0138 | Summit | New Jersey | 07901 | United States |
| Local Institution - 0009 | Albuquerque | New Mexico | 87106 | United States |
| Local Institution - 0184 | Mineola | New York | 11501 | United States |
| Local Institution - 0224 | Salisbury | North Carolina | 28144 | United States |
| Local Institution - 0130 | Duncansville | Pennsylvania | 16635 | United States |
| Local Institution - 0022 | Jackson | Tennessee | 38305 | United States |
| Local Institution - 0144 | Allen | Texas | 75013 | United States |
| Local Institution - 0227 | Katy | Texas | 77494 | United States |
| Local Institution - 0175 | Plano | Texas | 75024 | United States |
| Local Institution - 0133 | Seattle | Washington | 98195 | United States |
| Local Institution - 0189 | Spokane | Washington | 99204 | United States |
| Local Institution - 0050 | San Isidro | Alabama | 1643 | Argentina |
| Local Institution - 0100 | CABA | Buenos Aires | 1114 | Argentina |
| Local Institution - 0003 | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1123AAO | Argentina |
| Local Institution - 0019 | Quilmes | Buenos Aires | 1878 | Argentina |
| Local Institution - 0026 | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Local Institution - 0137 | CABA | 1405 | Argentina |
| Local Institution - 0109 | City of Buenos Aires | 1425 | Argentina |
| Local Institution - 0061 | Córdoba | X5004AUL | Argentina |
| Local Institution - 0120 | Woodville South | South Australia | 5011 | Australia |
| Local Institution - 0117 | Graz | A-8036 | Austria |
| Local Institution - 0087 | Vienna | A-1180 | Austria |
| Local Institution - 0172 | Ghent | 9000 | Belgium |
| Local Institution - 0170 | Vitória | Espírito Santo | 29041-295 | Brazil |
| Local Institution - 0106 | Belo Horizonte | Minas Gerais | 30130-100 | Brazil |
| Local Institution - 0091 | Juiz de Fora | Minas Gerais | 36010-570 | Brazil |
| Local Institution - 0055 | Porto Alegre | Rio Grande do Sul | 90560-030 | Brazil |
| Local Institution - 0018 | São Paulo | São Paulo | 04266-010 | Brazil |
| Local Institution - 0111 | Uberlândia | 38405-320 | Brazil |
| Local Institution - 0008 | Plovdiv | 4001 | Bulgaria |
| Local Institution - 0221 | Sofia | 1618 | Bulgaria |
| Local Institution - 0134 | Vancouver | British Columbia | V5Z 1L7 | Canada |
| Local Institution - 0063 | Toronto | Ontario | M5T 2S8 | Canada |
| Local Institution - 0004 | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Local Institution - 0056 | Trois-Rivières | Quebec | G8Z1Y2 | Canada |
| Local Institution - 0136 | Santiago | Providencia | 7501126 | Chile |
| Local Institution - 0097 | Santiago | Santiago Metropolitan | 7500710 | Chile |
| Local Institution - 0015 | Santiago de Chlie | Santiago Metropolitan | 8207257 | Chile |
| Local Institution - 0032 | Viña del Mar | Valparaiso | 2531172 | Chile |
| Local Institution - 0216 | Santiago | 8350488 | Chile |
| Local Institution - 0200 | Valdivia | 5110683 | Chile |
| Local Institution - 0153 | Beijing | Beijing Municipality | 100034 | China |
| Local Institution - 0156 | Beijing | Beijing Municipality | 100044 | China |
| Local Institution - 0160 | Beijing | Beijing Municipality | 100191 | China |
| Local Institution - 0155 | Xiamen | Fujian | 361003 | China |
| Local Institution - 0095 | Guangzhou | Guangdong | 510080 | China |
| Local Institution - 0212 | Shenzhen | Guangdong | 518020 | China |
| Local Institution - 0214 | Zhengzhou | Henan | 450052 | China |
| Local Institution - 0149 | Wuhan | Hubei | 430030 | China |
| Local Institution - 0094 | Changsha | Hunan | 410011 | China |
| Local Institution - 0158 | Changsha | Hunan | 410024 | China |
| Local Institution - 0150 | Hohhot | Inner Mongolia | 10000 | China |
| Local Institution - 0215 | Nanjing | Jiangsu | 210008 | China |
| Local Institution - 0159 | Nanjing | Jiangsu | 210029 | China |
| Local Institution - 0154 | Suzhou | Jiangsu | 215006 | China |
| Local Institution - 0177 | Nanchang | Jiangxi | 330006 | China |
| Local Institution - 0213 | Nanchang | Jiangxi | 330006 | China |
| Local Institution - 0162 | Pingxiang | Jiangxi | 337099 | China |
| Local Institution - 0101 | Xi'an | Shaanxi | 710061 | China |
| Local Institution - 0182 | Taiyuan | Shan1xi | 030032 | China |
| Local Institution - 0102 | Shanghai | Shanghai Municipality | 200000 | China |
| Local Institution - 0151 | Shanghai | Shanghai Municipality | 200065 | China |
| Local Institution - 0157 | Shanghai Shi | Shanghai Sheng | 200011 | China |
| Local Institution - 0178 | Chengdu | Sichuan | 610041 | China |
| Local Institution - 0179 | Ürümqi | Xinjiang Sheng | 830001 | China |
| Local Institution - 0181 | Hangzhou | Zhejiang | 310003 | China |
| Local Institution - 0152 | Hangzhou | Zhejiang | 314408 | China |
| Local Institution - 0161 | Ningbo | Zhejiang | 315010 | China |
| Local Institution - 0093 | Wenzhou | Zhejiang | 325000 | China |
| Local Institution - 0168 | Barranquilla | Atlántico | 080003 | Colombia |
| Local Institution - 0043 | Chía | Cundinamarca | 250001 | Colombia |
| Local Institution - 0037 | Bogota D.C | 110221 | Colombia |
| Local Institution - 0199 | Helsinki | 00290 | Finland |
| Local Institution - 0135 | Kuopio | 70100 | Finland |
| Local Institution - 0119 | Turku | 20520 | Finland |
| Local Institution - 0005 | Amiens | 80054 | France |
| Local Institution - 0073 | Bordeaux | 33075 | France |
| Local Institution - 0070 | Grenoble | 38043 | France |
| Local Institution - 0074 | Le Havre | 76083 | France |
| Local Institution - 0167 | Le Kremlin-Bictre | 94270 | France |
| Local Institution - 0025 | Paris | 75012 | France |
| Local Institution - 0107 | Paris | 75014 | France |
| Local Institution - 0057 | Paris | 75651 | France |
| Local Institution - 0079 | Munich | Bavaria | 80336 | Germany |
| Local Institution - 0092 | Berlin | 10117 | Germany |
| Local Institution - 0031 | Freiburg im Breisgau | 79106 | Germany |
| Local Institution - 0033 | Hamburg | 20095 | Germany |
| Local Institution - 0075 | Tübingen | 72076 | Germany |
| Local Institution - 0051 | Würzburg | 97080 | Germany |
| Local Institution - 0077 | Athens | 11527 | Greece |
| Local Institution - 0108 | Larissa | 41110 | Greece |
| Local Institution - 0083 | Debrecen | 4032 | Hungary |
| Local Institution - 0090 | Gyula | 5700 | Hungary |
| Local Institution - 0145 | Ramat Gan | IA | 5265601 | Israel |
| Local Institution - 0142 | Kfar Saba | 4428164 | Israel |
| Local Institution - 0065 | Brescia | 25123 | Italy |
| Local Institution - 0029 | Milan | 20122 | Italy |
| Local Institution - 0124 | Naples | 80131 | Italy |
| Local Institution - 0128 | Pisa | 56126 | Italy |
| Local Institution - 0069 | Rome | 00128 | Italy |
| Local Institution - 0081 | Udine | 33100 | Italy |
| Local Institution - 0146 | Nagoya | Aichi-ken | 457-8511 | Japan |
| Local Institution - 0205 | Toyoake-shi | Aichi-ken | 470-1192 | Japan |
| Local Institution - 0148 | Kitakyushu-shi | Fukuoka | 807-8556 | Japan |
| Local Institution - 0122 | Sapporo | Hokkaido | 0608543 | Japan |
| Local Institution - 0188 | Sapporo | Hokkaido | 0608648 | Japan |
| Local Institution - 0211 | Nishinomiya-shi | Hyōgo | 6638501 | Japan |
| Local Institution - 0193 | Tsukuba | Ibaraki | 3058576 | Japan |
| Local Institution - 0202 | Kahoku-gun | Ishikawa-ken | 9200293 | Japan |
| Local Institution - 0118 | Kanazawa | Ishikawa-ken | 9208641 | Japan |
| Local Institution - 0206 | Kawasaki-shi | Kanagawa | 2168511 | Japan |
| Local Institution - 0191 | Yokohama | Kanagawa | 2458575 | Japan |
| Local Institution - 0139 | Sendai | Miyagi | 980-8574 | Japan |
| Local Institution - 0147 | Nagasaki | Nagasaki | 8528501 | Japan |
| Local Institution - 0129 | Sasebo | Nagasaki | 8571195 | Japan |
| Local Institution - 0207 | Kurashiki | Okayama-ken | 7100824 | Japan |
| Local Institution - 0198 | Ōtsu | Shiga | 5250072 | Japan |
| Local Institution - 0194 | Hamamatsu | Shizuoka | 4313192 | Japan |
| Local Institution - 0195 | Shimotsugagun | Tochigi | 3210293 | Japan |
| Local Institution - 0210 | Bunkyo-ku | Tokyo | 1138421 | Japan |
| Local Institution - 0196 | Bunkyo-ku | Tokyo | 1138519 | Japan |
| Local Institution - 0190 | Chuo-ku | Tokyo | 1048560 | Japan |
| Local Institution - 0201 | Meguro-ku | Tokyo | 1528902 | Japan |
| Local Institution - 0208 | Meguro-ku | Tokyo | 1538515 | Japan |
| Local Institution - 0204 | Shinagawa-ku | Tokyo | 1420054 | Japan |
| Local Institution - 0197 | Shinjuku | Tokyo | 1608582 | Japan |
| Local Institution - 0192 | tabashi City | Tokyo | 1738610 | Japan |
| Local Institution - 0020 | León | Guanajuato | 37000 | Mexico |
| Local Institution - 0023 | Guadalajara | Jalisco | 44620 | Mexico |
| Local Institution - 0048 | Guadalajara | Jalisco | 44690 | Mexico |
| Local Institution - 0169 | Mexico City | Mexico City | 11850 | Mexico |
| Local Institution - 0001 | Groningen | 9713 GZ | Netherlands |
| Local Institution - 0105 | Rotterdam | 3015 GD | Netherlands |
| Local Institution - 0047 | Jesus Maria | Lima region | 15076 | Peru |
| Local Institution - 0011 | Santiago de Surco | Lima region | 1111 | Peru |
| Local Institution - 0171 | Lima | Lima 26 | Peru |
| Local Institution - 0084 | Krakow | Lesser Poland Voivodeship | 30-363 | Poland |
| Local Institution - 0054 | Warsaw | Masovian Voivodeship | 00-874 | Poland |
| Local Institution - 0141 | Warsaw | Woj. Mazowieckie | 02-118 | Poland |
| Local Institution - 0024 | Bydgoszcz | 85-065 | Poland |
| Local Institution - 0085 | Bydgoszcz | 85-168 | Poland |
| Local Institution - 0040 | Lublin | 20-412 | Poland |
| Local Institution - 0089 | Poznan | 60-693 | Poland |
| Local Institution - 0080 | Warsaw | 02 665 | Poland |
| Local Institution - 0076 | Warsaw | 02-637 | Poland |
| Local Institution - 0185 | Warsaw | 03-291 | Poland |
| Local Institution - 0064 | Wroclaw | 53-224 | Poland |
| Local Institution - 0036 | Wroclaw | 54-049 | Poland |
| Local Institution - 0028 | Lisbon | 1050-078 | Portugal |
| Local Institution - 0014 | Lisbon | 1649-035 | Portugal |
| Local Institution - 0143 | San Juan | 00917 | Puerto Rico |
| Local Institution - 0127 | San Juan | 00918 | Puerto Rico |
| Local Institution - 0220 | Cluj-Napoca | Cluj | 400006 | Romania |
| Local Institution - 0041 | Brasov | 500283 | Romania |
| Local Institution - 0219 | Bucharest | 011658 | Romania |
| Local Institution - 0110 | Seongdong-gu | Seoul | 04763 | South Korea |
| Local Institution - 0042 | Gwangju | 61469 | South Korea |
| Local Institution - 0126 | Seoul | 06591 | South Korea |
| Local Institution - 0209 | Seoul | 5030 | South Korea |
| Local Institution - 0038 | Mérida | Badajoz | 06800 | Spain |
| Local Institution - 0059 | Santander | Cantabria | 39008 | Spain |
| Local Institution - 0114 | San Cristóbal de La Laguna | Santa Cruz De Tenerife | 38320 | Spain |
| Local Institution - 0112 | A Coruña | 15006 | Spain |
| Local Institution - 0068 | Santiago de Compostela | 15702 | Spain |
| Local Institution - 0071 | Seville | 41010 | Spain |
| Local Institution - 0166 | Gothenburg | 405 30 | Sweden |
| Local Institution - 0164 | Stockholm | 11361 | Sweden |
| Local Institution - 0013 | Bern | 3010 | Switzerland |
| Local Institution - 0034 | Sankt Gallen | 9007 | Switzerland |
| Local Institution - 0116 | Kaohsiung City | 83301 | Taiwan |
| Local Institution - 0012 | Taichung | 40447 | Taiwan |
| Local Institution - 0002 | Taichung | 40705 | Taiwan |
| Local Institution - 0027 | Taipei | 100 | Taiwan |
| Local Institution - 0045 | Taoyuan City | 333 | Taiwan |
| Local Institution - 0035 | Yenimahalle | Ankara | 06500 | Turkey (Türkiye) |
| Local Institution - 0088 | Ankara | 06100 | Turkey (Türkiye) |
| Local Institution - 0007 | Antalya | 7058 | Turkey (Türkiye) |
| Local Institution - 0044 | Istanbul | 34098 | Turkey (Türkiye) |
| Local Institution - 0176 | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Local Institution - 0217 | Wolverhampton | West Midlands | WV10 0QP | United Kingdom |
| Local Institution - 0030 | Birmingham | B15 2WB | United Kingdom |
| Local Institution - 0060 | Cannock | WS11 5XY | United Kingdom |
| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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