Sjögren's SyndromePhase 3POETYK SjS-1NCT05946941

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

A Phase 3 study testing Deucravacitinib in people with Sjögren's Syndrome, run by Bristol-Myers Squibb at 199 sites in 33 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sjögren's Syndrome
What is being tested?: Deucravacitinib
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 774 participants
Where: 199 sitesin 33 countries
Study dates: 11 Sep 2023to 16 Nov 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

199 sites in 33 countries.

Country

City, postcode or hospital

199 sites in 33 countries

United States28 sites

Local Institution - 0009
Albuquerque, New Mexico, 87106
Local Institution - 0144
Allen, Texas, 75013
Local Institution - 0140
Augusta, Georgia, 30912
Local Institution - 0187
Baltimore, Maryland, 21224-2746
Local Institution - 0017
Baton Rouge, Louisiana, 70836
Local Institution - 0173
Boston, Massachusetts, 02111
Local Institution - 0049
Clearwater, Florida, 33765
Local Institution - 0226
Cooper City, Florida, 33024
Local Institution - 0067
Denver, Colorado, 80230
Local Institution - 0130
Duncansville, Pennsylvania, 16635
Local Institution - 0131
Eagan, Minnesota, 55123
Local Institution - 0228
Fullerton, California, 92835
Local Institution - 0022
Jackson, Tennessee, 38305
Local Institution - 0016
Kansas City, Kansas, 66160
Local Institution - 0227
Katy, Texas, 77494
Local Institution - 0222
La Palma, California, 90623
Local Institution - 0229
Lawrenceville, Georgia, 30046
Local Institution - 0184
Mineola, New York, 11501
Local Institution - 0125
Monroe, Louisiana, 71203
Local Institution - 0175
Plano, Texas, 75024
Local Institution - 0224
Salisbury, North Carolina, 28144
Local Institution - 0218
San Francisco, California, 94143
Local Institution - 0203
Santa Monica, California, 90404
Local Institution - 0223
Sarasota, Florida, 34239
Local Institution - 0133
Seattle, Washington, 98195
Local Institution - 0174
Skokie, Illinois, 60076
Local Institution - 0189
Spokane, Washington, 99204
Local Institution - 0138
Summit, New Jersey, 07901

Other trials in United States

China28 sites

Local Institution - 0153
Beijing, Beijing Municipality, 100034
Local Institution - 0156
Beijing, Beijing Municipality, 100044
Local Institution - 0160
Beijing, Beijing Municipality, 100191
Local Institution - 0094
Changsha, Hunan, 410011
Local Institution - 0158
Changsha, Hunan, 410024
Local Institution - 0178
Chengdu, Sichuan, 610041
Local Institution - 0095
Guangzhou, Guangdong, 510080
Local Institution - 0181
Hangzhou, Zhejiang, 310003
Local Institution - 0152
Hangzhou, Zhejiang, 314408
Local Institution - 0150
Hohhot, Inner Mongolia, 10000
Local Institution - 0177
Nanchang, Jiangxi, 330006
Local Institution - 0213
Nanchang, Jiangxi, 330006
Local Institution - 0215
Nanjing, Jiangsu, 210008
Local Institution - 0159
Nanjing, Jiangsu, 210029
Local Institution - 0161
Ningbo, Zhejiang, 315010
Local Institution - 0162
Pingxiang, Jiangxi, 337099
Local Institution - 0102
Shanghai, Shanghai Municipality, 200000
Local Institution - 0151
Shanghai, Shanghai Municipality, 200065
Local Institution - 0157
Shanghai Shi, Shanghai Sheng, 200011
Local Institution - 0212
Shenzhen, Guangdong, 518020
Local Institution - 0154
Suzhou, Jiangsu, 215006
Local Institution - 0182
Taiyuan, Shan1xi, 030032
Local Institution - 0179
Ürümqi, Xinjiang Sheng, 830001
Local Institution - 0093
Wenzhou, Zhejiang, 325000
Local Institution - 0149
Wuhan, Hubei, 430030
Local Institution - 0101
Xi'an, Shaanxi, 710061
Local Institution - 0155
Xiamen, Fujian, 361003
Local Institution - 0214
Zhengzhou, Henan, 450052

Other trials in China

Japan26 sites

Local Institution - 0210
Bunkyo-ku, Tokyo, 1138421
Local Institution - 0196
Bunkyo-ku, Tokyo, 1138519
Local Institution - 0190
Chuo-ku, Tokyo, 1048560
Local Institution - 0194
Hamamatsu, Shizuoka, 4313192
Local Institution - 0202
Kahoku-gun, Ishikawa-ken, 9200293
Local Institution - 0118
Kanazawa, Ishikawa-ken, 9208641
Local Institution - 0206
Kawasaki-shi, Kanagawa, 2168511
Local Institution - 0148
Kitakyushu-shi, Fukuoka, 807-8556
Local Institution - 0207
Kurashiki, Okayama-ken, 7100824
Local Institution - 0201
Meguro-ku, Tokyo, 1528902
Local Institution - 0208
Meguro-ku, Tokyo, 1538515
Local Institution - 0147
Nagasaki, Nagasaki, 8528501
Local Institution - 0146
Nagoya, Aichi-ken, 457-8511
Local Institution - 0211
Nishinomiya-shi, Hyōgo, 6638501
Local Institution - 0198
Ōtsu, Shiga, 5250072
Local Institution - 0122
Sapporo, Hokkaido, 0608543
Local Institution - 0188
Sapporo, Hokkaido, 0608648
Local Institution - 0129
Sasebo, Nagasaki, 8571195
Local Institution - 0139
Sendai, Miyagi, 980-8574
Local Institution - 0195
Shimotsugagun, Tochigi, 3210293
Local Institution - 0204
Shinagawa-ku, Tokyo, 1420054
Local Institution - 0197
Shinjuku, Tokyo, 1608582
Local Institution - 0192
tabashi City, Tokyo, 1738610
Local Institution - 0205
Toyoake-shi, Aichi-ken, 470-1192
Local Institution - 0193
Tsukuba, Ibaraki, 3058576
Local Institution - 0191
Yokohama, Kanagawa, 2458575

Other trials in Japan

Poland12 sites

Local Institution - 0024
Bydgoszcz, 85-065
Local Institution - 0085
Bydgoszcz, 85-168
Local Institution - 0084
Krakow, Lesser Poland Voivodeship, 30-363
Local Institution - 0040
Lublin, 20-412
Local Institution - 0089
Poznan, 60-693
Local Institution - 0054
Warsaw, Masovian Voivodeship, 00-874
Local Institution - 0141
Warsaw, Woj. Mazowieckie, 02-118
Local Institution - 0080
Warsaw, 02 665
Local Institution - 0076
Warsaw, 02-637
Local Institution - 0185
Warsaw, 03-291
Local Institution - 0064
Wroclaw, 53-224
Local Institution - 0036
Wroclaw, 54-049

Other trials in Poland

Argentina8 sites

Local Institution - 0100
CABA, Buenos Aires, 1114
Local Institution - 0137
CABA, 1405
Local Institution - 0109
City of Buenos Aires, 1425
Local Institution - 0003
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1123AAO
Local Institution - 0061
Córdoba, X5004AUL
Local Institution - 0019
Quilmes, Buenos Aires, 1878
Local Institution - 0050
San Isidro, Alabama, 1643
Local Institution - 0026
San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

France8 sites

Local Institution - 0005
Amiens, 80054
Local Institution - 0073
Bordeaux, 33075
Local Institution - 0070
Grenoble, 38043
Local Institution - 0074
Le Havre, 76083
Local Institution - 0167
Le Kremlin-Bictre, 94270
Local Institution - 0025
Paris, 75012
Local Institution - 0107
Paris, 75014
Local Institution - 0057
Paris, 75651

Other trials in France

Brazil6 sites

Local Institution - 0106
Belo Horizonte, Minas Gerais, 30130-100
Local Institution - 0091
Juiz de Fora, Minas Gerais, 36010-570
Local Institution - 0055
Porto Alegre, Rio Grande do Sul, 90560-030
Local Institution - 0018
São Paulo, São Paulo, 04266-010
Local Institution - 0111
Uberlândia, 38405-320
Local Institution - 0170
Vitória, Espírito Santo, 29041-295

Other trials in Brazil

Chile6 sites

Local Institution - 0136
Santiago, Providencia, 7501126
Local Institution - 0097
Santiago, Santiago Metropolitan, 7500710
Local Institution - 0216
Santiago, 8350488
Local Institution - 0015
Santiago de Chlie, Santiago Metropolitan, 8207257
Local Institution - 0200
Valdivia, 5110683
Local Institution - 0032
Viña del Mar, Valparaiso, 2531172

Other trials in Chile

Germany6 sites

Local Institution - 0092
Berlin, 10117
Local Institution - 0031
Freiburg im Breisgau, 79106
Local Institution - 0033
Hamburg, 20095
Local Institution - 0079
Munich, Bavaria, 80336
Local Institution - 0075
Tübingen, 72076
Local Institution - 0051
Würzburg, 97080

Other trials in Germany

Italy6 sites

Local Institution - 0065
Brescia, 25123
Local Institution - 0029
Milan, 20122
Local Institution - 0124
Naples, 80131
Local Institution - 0128
Pisa, 56126
Local Institution - 0069
Rome, 00128
Local Institution - 0081
Udine, 33100

Other trials in Italy

Spain6 sites

Local Institution - 0112
A Coruña, 15006
Local Institution - 0038
Mérida, Badajoz, 06800
Local Institution - 0114
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
Local Institution - 0059
Santander, Cantabria, 39008
Local Institution - 0068
Santiago de Compostela, 15702
Local Institution - 0071
Seville, 41010

Other trials in Spain

Taiwan5 sites

Local Institution - 0116
Kaohsiung City, 83301
Local Institution - 0012
Taichung, 40447
Local Institution - 0002
Taichung, 40705
Local Institution - 0027
Taipei, 100
Local Institution - 0045
Taoyuan City, 333

Other trials in Taiwan

Canada4 sites

Local Institution - 0004
Sherbrooke, Quebec, J1L 0H8
Local Institution - 0063
Toronto, Ontario, M5T 2S8
Local Institution - 0056
Trois-Rivières, Quebec, G8Z1Y2
Local Institution - 0134
Vancouver, British Columbia, V5Z 1L7

Other trials in Canada

Mexico4 sites

Local Institution - 0023
Guadalajara, Jalisco, 44620
Local Institution - 0048
Guadalajara, Jalisco, 44690
Local Institution - 0020
León, Guanajuato, 37000
Local Institution - 0169
Mexico City, Mexico City, 11850

Other trials in Mexico

South Korea4 sites

Local Institution - 0042
Gwangju, 61469
Local Institution - 0110
Seongdong-gu, Seoul, 04763
Local Institution - 0126
Seoul, 06591
Local Institution - 0209
Seoul, 5030

Other trials in South Korea

Turkey (Türkiye)4 sites

Local Institution - 0088
Ankara, 06100
Local Institution - 0007
Antalya, 7058
Local Institution - 0044
Istanbul, 34098
Local Institution - 0035
Yenimahalle, Ankara, 06500

Other trials in Turkey (Türkiye)

United Kingdom4 sites

Local Institution - 0030
Birmingham, B15 2WB
Local Institution - 0060
Cannock, WS11 5XY
Local Institution - 0176
Southampton, Hampshire, SO16 6YD
Local Institution - 0217
Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Colombia3 sites

Local Institution - 0168
Barranquilla, Atlántico, 080003
Local Institution - 0037
Bogota D.C, 110221
Local Institution - 0043
Chía, Cundinamarca, 250001

Other trials in Colombia

Finland3 sites

Local Institution - 0199
Helsinki, 00290
Local Institution - 0135
Kuopio, 70100
Local Institution - 0119
Turku, 20520

Other trials in Finland

Peru3 sites

Local Institution - 0047
Jesus Maria, Lima region, 15076
Local Institution - 0171
Lima, Lima 26
Local Institution - 0011
Santiago de Surco, Lima region, 1111

Other trials in Peru

Romania3 sites

Local Institution - 0041
Brasov, 500283
Local Institution - 0219
Bucharest, 011658
Local Institution - 0220
Cluj-Napoca, Cluj, 400006

Other trials in Romania

Austria2 sites

Local Institution - 0117
Graz, A-8036
Local Institution - 0087
Vienna, A-1180

Other trials in Austria

Bulgaria2 sites

Local Institution - 0008
Plovdiv, 4001
Local Institution - 0221
Sofia, 1618

Other trials in Bulgaria

Greece2 sites

Local Institution - 0077
Athens, 11527
Local Institution - 0108
Larissa, 41110

Other trials in Greece

Hungary2 sites

Local Institution - 0083
Debrecen, 4032
Local Institution - 0090
Gyula, 5700

Other trials in Hungary

Israel2 sites

Local Institution - 0142
Kfar Saba, 4428164
Local Institution - 0145
Ramat Gan, IA, 5265601

Other trials in Israel

Netherlands2 sites

Local Institution - 0001
Groningen, 9713 GZ
Local Institution - 0105
Rotterdam, 3015 GD

Other trials in Netherlands

Portugal2 sites

Local Institution - 0028
Lisbon, 1050-078
Local Institution - 0014
Lisbon, 1649-035

Other trials in Portugal

Puerto Rico2 sites

Local Institution - 0143
San Juan, 00917
Local Institution - 0127
San Juan, 00918

Other trials in Puerto Rico

Sweden2 sites

Local Institution - 0166
Gothenburg, 405 30
Local Institution - 0164
Stockholm, 11361

Other trials in Sweden

Switzerland2 sites

Local Institution - 0013
Bern, 3010
Local Institution - 0034
Sankt Gallen, 9007

Other trials in Switzerland

Australia1 site

Local Institution - 0120
Woodville South, South Australia, 5011

Other trials in Australia

Belgium1 site

Local Institution - 0172
Ghent, 9000

Other trials in Belgium

About this study

Official title: A 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)

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.

Conditions: Sjögren's Syndrome
Being tested: Deucravacitinib, Placebo
Keywords: Deucravacitinib, Sjogren's Syndrome, BMS-986165, POETYK, Sjogren Syndrome, Sjogren-Larson Syndrome, Gougerot-Sjogren, Gougerot Sjogren Syndrome, Sjogren, Sjogren's, Sjogren Disease, Sjogren's Disease
Medical subject headings: Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DeucravacitinibDrug
Also called BMS-986165
Specified dose on specified days
PlaceboOther
Specified dose on specified days

Study groups in NCT05946941
Study group	Role	What they receive
Deucravacitinib, Dose 1	Experimental	Not described Receives: Drug: Deucravacitinib
Deucravacitinib, Dose 2	Experimental	Not described Receives: Drug: Deucravacitinib
Placebo, followed by Deucravacitinib Dose 1 or Dose 2	Placebo comparator	Not described Receives: Drug: Deucravacitinib; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
Measured: Baseline, Week 52

Secondary outcomes (19)

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
Measured: Baseline, Week 52
Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
Measured: Baseline, Week 52
Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
Measured: Baseline, Week 52
Number of participants with ESSDAI < 5 at Week 52
Measured: Baseline, Week 52
Change from baseline in ESSDAI at Week 24
Measured: Baseline, Week 24
Change from baseline in stimulated whole salivary flow (SWSF) at Week 52
Measured: Baseline, Week 52
Change from baseline in physician global assessment (PhGA) at Week 52
Measured: Baseline, Week 52
Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
Measured: Baseline, Week 52
Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52
Measured: Baseline, Week 52
Change from baseline in oral dryness NRS at Week 52
Measured: Baseline, Week 52
Change from baseline in joint/ muscle pain NRS at Week 52
Measured: 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
Measured: Baseline, Week 52
Number of participants with adverse events (AEs)
Measured: Up to Week 160
Number of participants with serious AEs (SAEs)
Measured: Up to Week 160
Number of participants with AEs leading to discontinuation of treatment and study discontinuation
Measured: Up to Week 160
Number of participants with AEs of special interest (AESIs)
Measured: Up to Week 160
Number of participants with clinical laboratory abnormalities
Measured: Up to Week 160
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Week 156
Number of participants with vital sign abnormalities
Measured: Up to Week 160

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 202316 Nov 2028

First posted14 Jul 2023
Study start11 Sep 2023
Primary completion18 Nov 2026 (estimated)
Study completion16 Nov 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 774 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05946941
Sponsor's protocol ID: IM011-1069
Other IDs: 2023-503327-26, U111-1289-6072, 2023
Acronym: POETYK SjS-1
Status last verified: Mar 2026
First submitted: 7 Jul 2023
Last updated: 1 Apr 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 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)
ClinicalTrials.gov ID: NCT05946941
Acronym / sponsor ID: POETYK SjS-1 / IM011-1069
Conditions: Sjögren's Syndrome
Keywords: Deucravacitinib, Sjogren's Syndrome, BMS-986165, POETYK, Sjogren Syndrome, Sjogren-Larson Syndrome, Gougerot-Sjogren, Gougerot Sjogren Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 774 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 11 Sep 2023 (actual)
Primary completion: 18 Nov 2026 (estimated)
Study completion: 16 Nov 2028 (estimated)
First posted: 14 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Deucravacitinib, Dose 1	Experimental	Drug: Deucravacitinib
Deucravacitinib, Dose 2	Experimental	Drug: Deucravacitinib
Placebo, followed by Deucravacitinib Dose 1 or Dose 2	Placebo comparator	Drug: Deucravacitinib, Other: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DeucravacitinibAlso: BMS-986165Specified dose on specified days	Drug	Deucravacitinib, Dose 1, Deucravacitinib, Dose 2, Placebo, followed by Deucravacitinib Dose 1 or Dose 2
PlaceboSpecified dose on specified days	Other	Placebo, followed by Deucravacitinib Dose 1 or Dose 2

Primary outcome

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
Time frame: Baseline, Week 52

19 secondary outcomes

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
Time frame: Baseline, Week 52
Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
Time frame: Baseline, Week 52
Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
Time frame: Baseline, Week 52
Number of participants with ESSDAI < 5 at Week 52
Time frame: Baseline, Week 52
Change from baseline in ESSDAI at Week 24
Time frame: Baseline, Week 24
Change from baseline in stimulated whole salivary flow (SWSF) at Week 52
Time frame: Baseline, Week 52
Change from baseline in physician global assessment (PhGA) at Week 52
Time frame: Baseline, Week 52
Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
Time frame: Baseline, Week 52
Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52
Time frame: Baseline, Week 52
Change from baseline in oral dryness NRS at Week 52
Time frame: Baseline, Week 52
Change from baseline in joint/ muscle pain NRS at Week 52
Time frame: 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
Time frame: Baseline, Week 52
Number of participants with adverse events (AEs)
Time frame: Up to Week 160
Number of participants with serious AEs (SAEs)
Time frame: Up to Week 160
Number of participants with AEs leading to discontinuation of treatment and study discontinuation
Time frame: Up to Week 160
Number of participants with AEs of special interest (AESIs)
Time frame: Up to Week 160
Number of participants with clinical laboratory abnormalities
Time frame: Up to Week 160
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Week 156
Number of participants with vital sign abnormalities
Time frame: Up to Week 160

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

199 sites in 33 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Deucravacitinib in people with Sjögren's Syndrome, run by Bristol-Myers Squibb at 199 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 199 sites in United States, China, Japan, Poland, Argentina and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52 (time frame: Baseline, Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05946941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.