A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified February 2026 by Bristol-Myers Squibb
Sponsor
Bristol-Myers Squibb
Information Provided by (Responsible Party)
Bristol-Myers Squibb
Clinicaltrials.gov Identifier
NCT05946941
Other Study ID Numbers:
IM011-1069
First Submitted
July 6, 2023
First Posted
July 13, 2023
Last Update Posted
March 31, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Sjögren's Syndrome
Drug: DeucravacitinibDrug: DeucravacitinibDrug: Deucravacitinib

Study Design

Study TypeInterventional
Actual Enrollment774 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)
Study Start DateSeptember 10, 2023
Actual Primary Completion Date3mos 3w from now
Actual Study Completion Date2yrs 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Deucravacitinib, Dose 1
Drug: Deucravacitinib
Specified dose on specified days
Deucravacitinib, Dose 2
Drug: Deucravacitinib
Specified dose on specified days
Placebo, followed by Deucravacitinib Dose 1 or Dose 2
Drug: Deucravacitinib
Specified dose on specified days

Outcome Measures

Primary Outcome Measures
  1. Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
Secondary Outcome Measures
  1. Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
  2. Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
  3. Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
  4. Number of participants with ESSDAI < 5 at Week 52
  5. Change from baseline in ESSDAI at Week 24
  6. Change from baseline in stimulated whole salivary flow (SWSF) at Week 52
  7. Change from baseline in physician global assessment (PhGA) at Week 52
  8. Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
  9. Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52
  10. Change from baseline in oral dryness NRS at Week 52
  11. Change from baseline in joint/ muscle pain NRS at Week 52
  12. 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
  13. Number of participants with adverse events (AEs)
  14. Number of participants with serious AEs (SAEs)
  15. Number of participants with AEs leading to discontinuation of treatment and study discontinuation
  16. Number of participants with AEs of special interest (AESIs)
  17. Number of participants with clinical laboratory abnormalities
  18. Number of participants with electrocardiogram (ECG) abnormalities
  19. Number of participants with vital sign abnormalities

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion 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
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.

Contacts and Locations

Sponsors and CollaboratorsBristol-Myers Squibb
Locations
Local Institution - 0228 | Fullerton California, United States, 92835Local Institution - 0222 | La Palma California, United States, 90623Local Institution - 0218 | San Francisco California, United States, 94143Local Institution - 0203 | Santa Monica California, United States, 90404Local Institution - 0067 | Denver Colorado, United States, 80230Local Institution - 0049 | Clearwater Florida, United States, 33765Local Institution - 0226 | Cooper City Florida, United States, 33024Local Institution - 0223 | Sarasota Florida, United States, 34239Local Institution - 0140 | Augusta Georgia, United States, 30912Local Institution - 0229 | Lawrenceville Georgia, United States, 30046Local Institution - 0174 | Skokie Illinois, United States, 60076Local Institution - 0016 | Kansas City Kansas, United States, 66160Local Institution - 0017 | Baton Rouge Louisiana, United States, 70836Local Institution - 0125 | Monroe Louisiana, United States, 71203Local Institution - 0187 | Baltimore Maryland, United States, 21224-2746Local Institution - 0173 | Boston Massachusetts, United States, 02111Local Institution - 0131 | Eagan Minnesota, United States, 55123Local Institution - 0138 | Summit New Jersey, United States, 07901Local Institution - 0009 | Albuquerque New Mexico, United States, 87106Local Institution - 0184 | Mineola New York, United States, 11501Local Institution - 0224 | Salisbury North Carolina, United States, 28144Local Institution - 0130 | Duncansville Pennsylvania, United States, 16635Local Institution - 0022 | Jackson Tennessee, United States, 38305Local Institution - 0144 | Allen Texas, United States, 75013Local Institution - 0227 | Katy Texas, United States, 77494Local Institution - 0175 | Plano Texas, United States, 75024Local Institution - 0133 | Seattle Washington, United States, 98195Local Institution - 0189 | Spokane Washington, United States, 99204Local Institution - 0050 | San Isidro Alabama, Argentina, 1643Local Institution - 0100 | CABA Buenos Aires, Argentina, 1114Local Institution - 0003 | Ciudad Autonoma de Buenos Aires Buenos Aires, Argentina, C1123AAOLocal Institution - 0019 | Quilmes Buenos Aires, Argentina, 1878Local Institution - 0026 | San Miguel de Tucumán Tucumán Province, Argentina, 4000Local Institution - 0137 | CABA , Argentina, 1405Local Institution - 0109 | City of Buenos Aires , Argentina, 1425Local Institution - 0061 | Córdoba , Argentina, X5004AULLocal Institution - 0120 | Woodville South South Australia, Australia, 5011Local Institution - 0117 | Graz , Austria, A-8036Local Institution - 0087 | Vienna , Austria, A-1180Local Institution - 0172 | Ghent , Belgium, 9000Local Institution - 0170 | Vitória Espírito Santo, Brazil, 29041-295Local Institution - 0106 | Belo Horizonte Minas Gerais, Brazil, 30130-100Local Institution - 0091 | Juiz de Fora Minas Gerais, Brazil, 36010-570Local Institution - 0055 | Porto Alegre Rio Grande do Sul, Brazil, 90560-030Local Institution - 0018 | São Paulo São Paulo, Brazil, 04266-010Local Institution - 0111 | Uberlândia , Brazil, 38405-320Local Institution - 0008 | Plovdiv , Bulgaria, 4001Local Institution - 0221 | Sofia , Bulgaria, 1618Local Institution - 0134 | Vancouver British Columbia, Canada, V5Z 1L7Local Institution - 0063 | Toronto Ontario, Canada, M5T 2S8Local Institution - 0004 | Sherbrooke Quebec, Canada, J1L 0H8Local Institution - 0056 | Trois-Rivières Quebec, Canada, G8Z1Y2Local Institution - 0136 | Santiago Providencia, Chile, 7501126Local Institution - 0097 | Santiago Santiago Metropolitan, Chile, 7500710Local Institution - 0015 | Santiago de Chlie Santiago Metropolitan, Chile, 8207257Local Institution - 0032 | Viña del Mar Valparaiso, Chile, 2531172Local Institution - 0216 | Santiago , Chile, 8350488Local Institution - 0200 | Valdivia , Chile, 5110683Local Institution - 0153 | Beijing Beijing Municipality, China, 100034Local Institution - 0156 | Beijing Beijing Municipality, China, 100044Local Institution - 0160 | Beijing Beijing Municipality, China, 100191Local Institution - 0155 | Xiamen Fujian, China, 361003Local Institution - 0095 | Guangzhou Guangdong, China, 510080Local Institution - 0212 | Shenzhen Guangdong, China, 518020Local Institution - 0214 | Zhengzhou Henan, China, 450052Local Institution - 0149 | Wuhan Hubei, China, 430030Local Institution - 0094 | Changsha Hunan, China, 410011Local Institution - 0158 | Changsha Hunan, China, 410024Local Institution - 0150 | Hohhot Inner Mongolia, China, 10000Local Institution - 0215 | Nanjing Jiangsu, China, 210008Local Institution - 0159 | Nanjing Jiangsu, China, 210029Local Institution - 0154 | Suzhou Jiangsu, China, 215006Local Institution - 0177 | Nanchang Jiangxi, China, 330006Local Institution - 0213 | Nanchang Jiangxi, China, 330006Local Institution - 0162 | Pingxiang Jiangxi, China, 337099Local Institution - 0101 | Xi'an Shaanxi, China, 710061Local Institution - 0182 | Taiyuan Shan1xi, China, 030032Local Institution - 0102 | Shanghai Shanghai Municipality, China, 200000Local Institution - 0151 | Shanghai Shanghai Municipality, China, 200065Local Institution - 0157 | Shanghai Shi Shanghai Sheng, China, 200011Local Institution - 0178 | Chengdu Sichuan, China, 610041Local Institution - 0179 | Ürümqi Xinjiang Sheng, China, 830001Local Institution - 0181 | Hangzhou Zhejiang, China, 310003Local Institution - 0152 | Hangzhou Zhejiang, China, 314408Local Institution - 0161 | Ningbo Zhejiang, China, 315010Local Institution - 0093 | Wenzhou Zhejiang, China, 325000Local Institution - 0168 | Barranquilla Atlántico, Colombia, 080003Local Institution - 0043 | Chía Cundinamarca, Colombia, 250001Local Institution - 0037 | Bogota D.C , Colombia, 110221Local Institution - 0199 | Helsinki , Finland, 00290Local Institution - 0135 | Kuopio , Finland, 70100Local Institution - 0119 | Turku , Finland, 20520Local Institution - 0005 | Amiens , France, 80054Local Institution - 0073 | Bordeaux , France, 33075Local Institution - 0070 | Grenoble , France, 38043Local Institution - 0074 | Le Havre , France, 76083Local Institution - 0167 | Le Kremlin-Bictre , France, 94270Local Institution - 0025 | Paris , France, 75012Local Institution - 0107 | Paris , France, 75014Local Institution - 0057 | Paris , France, 75651Local Institution - 0079 | Munich Bavaria, Germany, 80336Local Institution - 0092 | Berlin , Germany, 10117Local Institution - 0031 | Freiburg im Breisgau , Germany, 79106Local Institution - 0033 | Hamburg , Germany, 20095Local Institution - 0075 | Tübingen , Germany, 72076Local Institution - 0051 | Würzburg , Germany, 97080Local Institution - 0077 | Athens , Greece, 11527Local Institution - 0108 | Larissa , Greece, 41110Local Institution - 0083 | Debrecen , Hungary, 4032Local Institution - 0090 | Gyula , Hungary, 5700Local Institution - 0145 | Ramat Gan IA, Israel, 5265601Local Institution - 0142 | Kfar Saba , Israel, 4428164Local Institution - 0065 | Brescia , Italy, 25123Local Institution - 0029 | Milan , Italy, 20122Local Institution - 0124 | Naples , Italy, 80131Local Institution - 0128 | Pisa , Italy, 56126Local Institution - 0069 | Rome , Italy, 00128Local Institution - 0081 | Udine , Italy, 33100Local Institution - 0146 | Nagoya Aichi-ken, Japan, 457-8511Local Institution - 0205 | Toyoake-shi Aichi-ken, Japan, 470-1192Local Institution - 0148 | Kitakyushu-shi Fukuoka, Japan, 807-8556Local Institution - 0122 | Sapporo Hokkaido, Japan, 0608543Local Institution - 0188 | Sapporo Hokkaido, Japan, 0608648Local Institution - 0211 | Nishinomiya-shi Hyōgo, Japan, 6638501Local Institution - 0193 | Tsukuba Ibaraki, Japan, 3058576Local Institution - 0202 | Kahoku-gun Ishikawa-ken, Japan, 9200293Local Institution - 0118 | Kanazawa Ishikawa-ken, Japan, 9208641Local Institution - 0206 | Kawasaki-shi Kanagawa, Japan, 2168511Local Institution - 0191 | Yokohama Kanagawa, Japan, 2458575Local Institution - 0139 | Sendai Miyagi, Japan, 980-8574Local Institution - 0147 | Nagasaki Nagasaki, Japan, 8528501Local Institution - 0129 | Sasebo Nagasaki, Japan, 8571195Local Institution - 0207 | Kurashiki Okayama-ken, Japan, 7100824Local Institution - 0198 | Ōtsu Shiga, Japan, 5250072Local Institution - 0194 | Hamamatsu Shizuoka, Japan, 4313192Local Institution - 0195 | Shimotsugagun Tochigi, Japan, 3210293Local Institution - 0210 | Bunkyo-ku Tokyo, Japan, 1138421Local Institution - 0196 | Bunkyo-ku Tokyo, Japan, 1138519Local Institution - 0190 | Chuo-ku Tokyo, Japan, 1048560Local Institution - 0201 | Meguro-ku Tokyo, Japan, 1528902Local Institution - 0208 | Meguro-ku Tokyo, Japan, 1538515Local Institution - 0204 | Shinagawa-ku Tokyo, Japan, 1420054Local Institution - 0197 | Shinjuku Tokyo, Japan, 1608582Local Institution - 0192 | tabashi City Tokyo, Japan, 1738610Local Institution - 0020 | León Guanajuato, Mexico, 37000Local Institution - 0023 | Guadalajara Jalisco, Mexico, 44620Local Institution - 0048 | Guadalajara Jalisco, Mexico, 44690Local Institution - 0169 | Mexico City Mexico City, Mexico, 11850Local Institution - 0001 | Groningen , Netherlands, 9713 GZLocal Institution - 0105 | Rotterdam , Netherlands, 3015 GDLocal Institution - 0047 | Jesus Maria Lima region, Peru, 15076Local Institution - 0011 | Santiago de Surco Lima region, Peru, 1111Local Institution - 0171 | Lima , Peru, Lima 26Local Institution - 0084 | Krakow Lesser Poland Voivodeship, Poland, 30-363Local Institution - 0054 | Warsaw Masovian Voivodeship, Poland, 00-874Local Institution - 0141 | Warsaw Woj. Mazowieckie, Poland, 02-118Local Institution - 0024 | Bydgoszcz , Poland, 85-065Local Institution - 0085 | Bydgoszcz , Poland, 85-168Local Institution - 0040 | Lublin , Poland, 20-412Local Institution - 0089 | Poznan , Poland, 60-693Local Institution - 0080 | Warsaw , Poland, 02 665Local Institution - 0076 | Warsaw , Poland, 02-637Local Institution - 0185 | Warsaw , Poland, 03-291Local Institution - 0064 | Wroclaw , Poland, 53-224Local Institution - 0036 | Wroclaw , Poland, 54-049Local Institution - 0028 | Lisbon , Portugal, 1050-078Local Institution - 0014 | Lisbon , Portugal, 1649-035Local Institution - 0143 | San Juan , Puerto Rico, 00917Local Institution - 0127 | San Juan , Puerto Rico, 00918Local Institution - 0220 | Cluj-Napoca Cluj, Romania, 400006Local Institution - 0041 | Brasov , Romania, 500283Local Institution - 0219 | Bucharest , Romania, 011658Local Institution - 0110 | Seongdong-gu Seoul, South Korea, 04763Local Institution - 0042 | Gwangju , South Korea, 61469Local Institution - 0126 | Seoul , South Korea, 06591Local Institution - 0209 | Seoul , South Korea, 5030Local Institution - 0038 | Mérida Badajoz, Spain, 06800Local Institution - 0059 | Santander Cantabria, Spain, 39008Local Institution - 0114 | San Cristóbal de La Laguna Santa Cruz De Tenerife, Spain, 38320Local Institution - 0112 | A Coruña , Spain, 15006Local Institution - 0068 | Santiago de Compostela , Spain, 15702Local Institution - 0071 | Seville , Spain, 41010Local Institution - 0166 | Gothenburg , Sweden, 405 30Local Institution - 0164 | Stockholm , Sweden, 11361Local Institution - 0013 | Bern , Switzerland, 3010Local Institution - 0034 | Sankt Gallen , Switzerland, 9007Local Institution - 0116 | Kaohsiung City , Taiwan, 83301Local Institution - 0012 | Taichung , Taiwan, 40447Local Institution - 0002 | Taichung , Taiwan, 40705Local Institution - 0027 | Taipei , Taiwan, 100Local Institution - 0045 | Taoyuan City , Taiwan, 333Local Institution - 0035 | Yenimahalle Ankara, Turkey (Türkiye), 06500Local Institution - 0088 | Ankara , Turkey (Türkiye), 06100Local Institution - 0007 | Antalya , Turkey (Türkiye), 7058Local Institution - 0044 | Istanbul , Turkey (Türkiye), 34098Local Institution - 0176 | Southampton Hampshire, United Kingdom, SO16 6YDLocal Institution - 0217 | Wolverhampton West Midlands, United Kingdom, WV10 0QPLocal Institution - 0030 | Birmingham , United Kingdom, B15 2WBLocal Institution - 0060 | Cannock , United Kingdom, WS11 5XY
Investigators
Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb