A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome (POETYK SjS-1)

March 31, 2026 updated by: Bristol-Myers Squibb

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
774

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • CABA, Argentina, 1405
        • Local Institution - 0137
      • City of Buenos Aires, Argentina, 1425
        • Local Institution - 0109
      • Córdoba, Argentina, X5004AUL
        • Local Institution - 0061
    • Alabama
      • San Isidro, Alabama, Argentina, 1643
        • Local Institution - 0050
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, 1114
        • Local Institution - 0100
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1123AAO
        • Local Institution - 0003
      • Quilmes, Buenos Aires, Argentina, 1878
        • Local Institution - 0019
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • Local Institution - 0026
  • Australia
    • South Australia
      • Woodville South, South Australia, Australia, 5011
        • Local Institution - 0120
  • Austria
      • Graz, Austria, A-8036
        • Local Institution - 0117
      • Vienna, Austria, A-1180
        • Local Institution - 0087
  • Belgium
      • Ghent, Belgium, 9000
        • Local Institution - 0172
  • Brazil
      • Uberlândia, Brazil, 38405-320
        • Local Institution - 0111
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29041-295
        • Local Institution - 0170
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
        • Local Institution - 0106
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Local Institution - 0091
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
        • Local Institution - 0055
    • São Paulo
      • São Paulo, São Paulo, Brazil, 04266-010
        • Local Institution - 0018
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • Local Institution - 0008
      • Sofia, Bulgaria, 1618
        • Local Institution - 0221
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L7
        • Local Institution - 0134
    • Ontario
      • Toronto, Ontario, Canada, M5T 2S8
        • Local Institution - 0063
    • Quebec
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Local Institution - 0004
      • Trois-Rivières, Quebec, Canada, G8Z1Y2
        • Local Institution - 0056
  • Chile
      • Santiago, Chile, 8350488
        • Local Institution - 0216
      • Valdivia, Chile, 5110683
        • Local Institution - 0200
    • Providencia
      • Santiago, Providencia, Chile, 7501126
        • Local Institution - 0136
    • Región de Valparaíso
      • Viña del Mar, Región de Valparaíso, Chile, 2531172
        • Local Institution - 0032
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile, 7500710
        • Local Institution - 0097
      • Santiago de Chlie, Santiago Metropolitan, Chile, 8207257
        • Local Institution - 0015
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
        • Local Institution - 0153
      • Beijing, Beijing Municipality, China, 100044
        • Local Institution - 0156
      • Beijing, Beijing Municipality, China, 100191
        • Local Institution - 0160
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Local Institution - 0155
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Local Institution - 0095
      • Shenzhen, Guangdong, China, 518020
        • Local Institution - 0212
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Local Institution - 0214
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Local Institution - 0149
    • Hunan
      • Changsha, Hunan, China, 410011
        • Local Institution - 0094
      • Changsha, Hunan, China, 410024
        • Local Institution - 0158
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 10000
        • Local Institution - 0150
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Local Institution - 0215
      • Nanjing, Jiangsu, China, 210029
        • Local Institution - 0159
      • Suzhou, Jiangsu, China, 215006
        • Local Institution - 0154
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Local Institution - 0213
      • Nanchang, Jiangxi, China, 330006
        • Local Institution - 0177
      • Pingxiang, Jiangxi, China, 337099
        • Local Institution - 0162
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Local Institution - 0101
    • Shan1xi
      • Taiyuan, Shan1xi, China, 030032
        • Local Institution - 0182
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Local Institution - 0102
      • Shanghai, Shanghai Municipality, China, 200065
        • Local Institution - 0151
    • Shanghai Sheng
      • Shanghai Shi, Shanghai Sheng, China, 200011
        • Local Institution - 0157
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution - 0178
    • Xinjiang Sheng
      • Ürümqi, Xinjiang Sheng, China, 830001
        • Local Institution - 0179
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Local Institution - 0181
      • Hangzhou, Zhejiang, China, 314408
        • Local Institution - 0152
      • Ningbo, Zhejiang, China, 315010
        • Local Institution - 0161
      • Wenzhou, Zhejiang, China, 325000
        • Local Institution - 0093
  • Colombia
      • Bogota D.C, Colombia, 110221
        • Local Institution - 0037
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080003
        • Local Institution - 0168
    • Cundinamarca
      • Chía, Cundinamarca, Colombia, 250001
        • Local Institution - 0043
  • Finland
      • Helsinki, Finland, 00290
        • Local Institution - 0199
      • Kuopio, Finland, 70100
        • Local Institution - 0135
      • Turku, Finland, 20520
        • Local Institution - 0119
  • France
      • Amiens, France, 80054
        • Local Institution - 0005
      • Bordeaux, France, 33075
        • Local Institution - 0073
      • Grenoble, France, 38043
        • Local Institution - 0070
      • Le Havre, France, 76083
        • Local Institution - 0074
      • Le Kremlin-Bictre, France, 94270
        • Local Institution - 0167
      • Paris, France, 75012
        • Local Institution - 0025
      • Paris, France, 75014
        • Local Institution - 0107
      • Paris, France, 75651
        • Local Institution - 0057
  • Germany
      • Berlin, Germany, 10117
        • Local Institution - 0092
      • Freiburg im Breisgau, Germany, 79106
        • Local Institution - 0031
      • Hamburg, Germany, 20095
        • Local Institution - 0033
      • Tübingen, Germany, 72076
        • Local Institution - 0075
      • Würzburg, Germany, 97080
        • Local Institution - 0051
    • Bavaria
      • Munich, Bavaria, Germany, 80336
        • Local Institution - 0079
  • Greece
      • Athens, Greece, 11527
        • Local Institution - 0077
      • Larissa, Greece, 41110
        • Local Institution - 0108
  • Hungary
      • Debrecen, Hungary, 4032
        • Local Institution - 0083
      • Gyula, Hungary, 5700
        • Local Institution - 0090
  • Israel
      • Kfar Saba, Israel, 4428164
        • Local Institution - 0142
    • IA
      • Ramat Gan, IA, Israel, 5265601
        • Local Institution - 0145
  • Italy
      • Brescia, Italy, 25123
        • Local Institution - 0065
      • Milan, Italy, 20122
        • Local Institution - 0029
      • Naples, Italy, 80131
        • Local Institution - 0124
      • Pisa, Italy, 56126
        • Local Institution - 0128
      • Rome, Italy, 00128
        • Local Institution - 0069
      • Udine, Italy, 33100
        • Local Institution - 0081
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 457-8511
        • Local Institution - 0146
      • Toyoake-shi, Aichi-ken, Japan, 470-1192
        • Local Institution - 0205
    • Fukuoka
      • Kitakyushu-shi, Fukuoka, Japan, 807-8556
        • Local Institution - 0148
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 0608543
        • Local Institution - 0122
      • Sapporo, Hokkaido, Japan, 0608648
        • Local Institution - 0188
    • Hyōgo
      • Nishinomiya-shi, Hyōgo, Japan, 6638501
        • Local Institution - 0211
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 3058576
        • Local Institution - 0193
    • Ishikawa-ken
      • Kahoku-gun, Ishikawa-ken, Japan, 9200293
        • Local Institution - 0202
      • Kanazawa, Ishikawa-ken, Japan, 9208641
        • Local Institution - 0118
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 2168511
        • Local Institution - 0206
      • Yokohama, Kanagawa, Japan, 2458575
        • Local Institution - 0191
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Local Institution - 0139
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 8528501
        • Local Institution - 0147
      • Sasebo, Nagasaki, Japan, 8571195
        • Local Institution - 0129
    • Okayama-ken
      • Kurashiki, Okayama-ken, Japan, 7100824
        • Local Institution - 0207
    • Shiga
      • Ōtsu, Shiga, Japan, 5250072
        • Local Institution - 0198
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 4313192
        • Local Institution - 0194
    • Tochigi
      • Shimotsugagun, Tochigi, Japan, 3210293
        • Local Institution - 0195
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138421
        • Local Institution - 0210
      • Bunkyo-ku, Tokyo, Japan, 1138519
        • Local Institution - 0196
      • Chuo-ku, Tokyo, Japan, 1048560
        • Local Institution - 0190
      • Meguro-ku, Tokyo, Japan, 1528902
        • Local Institution - 0201
      • Meguro-ku, Tokyo, Japan, 1538515
        • Local Institution - 0208
      • Shinagawa-ku, Tokyo, Japan, 1420054
        • Local Institution - 0204
      • Shinjuku, Tokyo, Japan, 1608582
        • Local Institution - 0197
      • tabashi City, Tokyo, Japan, 1738610
        • Local Institution - 0192
  • Mexico
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Local Institution - 0020
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44620
        • Local Institution - 0023
      • Guadalajara, Jalisco, Mexico, 44690
        • Local Institution - 0048
    • Mexico City
      • Mexico City, Mexico City, Mexico, 11850
        • Local Institution - 0169
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Local Institution - 0001
      • Rotterdam, Netherlands, 3015 GD
        • Local Institution - 0105
  • Peru
      • Lima, Peru, Lima 26
        • Local Institution - 0171
    • Lima region
      • Jesus Maria, Lima region, Peru, 15076
        • Local Institution - 0047
      • Santiago de Surco, Lima region, Peru, 1111
        • Local Institution - 0011
  • Poland
      • Bydgoszcz, Poland, 85-065
        • Local Institution - 0024
      • Bydgoszcz, Poland, 85-168
        • Local Institution - 0085
      • Lublin, Poland, 20-412
        • Local Institution - 0040
      • Poznan, Poland, 60-693
        • Local Institution - 0089
      • Warsaw, Poland, 02 665
        • Local Institution - 0080
      • Warsaw, Poland, 02-637
        • Local Institution - 0076
      • Warsaw, Poland, 03-291
        • Local Institution - 0185
      • Wroclaw, Poland, 53-224
        • Local Institution - 0064
      • Wroclaw, Poland, 54-049
        • Local Institution - 0036
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-363
        • Local Institution - 0084
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 00-874
        • Local Institution - 0054
    • Woj. Mazowieckie
      • Warsaw, Woj. Mazowieckie, Poland, 02-118
        • Local Institution - 0141
  • Portugal
      • Lisbon, Portugal, 1050-078
        • Local Institution - 0028
      • Lisbon, Portugal, 1649-035
        • Local Institution - 0014
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Local Institution - 0143
      • San Juan, Puerto Rico, 00918
        • Local Institution - 0127
  • Romania
      • Brasov, Romania, 500283
        • Local Institution - 0041
      • Bucharest, Romania, 011658
        • Local Institution - 0219
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400006
        • Local Institution - 0220
  • South Korea
      • Gwangju, South Korea, 61469
        • Local Institution - 0042
      • Seoul, South Korea, 06591
        • Local Institution - 0126
      • Seoul, South Korea, 5030
        • Local Institution - 0209
    • Seoul
      • Seongdong-gu, Seoul, South Korea, 04763
        • Local Institution - 0110
  • Spain
      • A Coruña, Spain, 15006
        • Local Institution - 0112
      • Santiago de Compostela, Spain, 15702
        • Local Institution - 0068
      • Seville, Spain, 41010
        • Local Institution - 0071
    • Badajoz
      • Mérida, Badajoz, Spain, 06800
        • Local Institution - 0038
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Local Institution - 0059
    • Santa Cruz De Tenerife
      • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Local Institution - 0114
  • Sweden
      • Gothenburg, Sweden, 405 30
        • Local Institution - 0166
      • Stockholm, Sweden, 11361
        • Local Institution - 0164
  • Switzerland
      • Bern, Switzerland, 3010
        • Local Institution - 0013
      • Sankt Gallen, Switzerland, 9007
        • Local Institution - 0034
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Local Institution - 0116
      • Taichung, Taiwan, 40447
        • Local Institution - 0012
      • Taichung, Taiwan, 40705
        • Local Institution - 0002
      • Taipei, Taiwan, 100
        • Local Institution - 0027
      • Taoyuan, Taiwan, 333
        • Local Institution - 0045
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Local Institution - 0088
      • Antalya, Turkey (Türkiye), 7058
        • Local Institution - 0007
      • Istanbul, Turkey (Türkiye), 34098
        • Local Institution - 0044
    • Ankara
      • Yenimahalle, Ankara, Turkey (Türkiye), 06500
        • Local Institution - 0035
  • United Kingdom
      • Birmingham, United Kingdom, B15 2WB
        • Local Institution - 0030
      • Cannock, United Kingdom, WS11 5XY
        • Local Institution - 0060
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Local Institution - 0176
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
        • Local Institution - 0217
  • United States
    • California
      • Fullerton, California, United States, 92835
        • Local Institution - 0228
      • La Palma, California, United States, 90623
        • Local Institution - 0222
      • San Francisco, California, United States, 94143
        • Local Institution - 0218
      • Santa Monica, California, United States, 90404
        • Local Institution - 0203
    • Colorado
      • Denver, Colorado, United States, 80230
        • Local Institution - 0067
    • Florida
      • Clearwater, Florida, United States, 33765
        • Local Institution - 0049
      • Cooper City, Florida, United States, 33024
        • Local Institution - 0226
      • Sarasota, Florida, United States, 34239
        • Local Institution - 0223
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Local Institution - 0140
      • Lawrenceville, Georgia, United States, 30046
        • Local Institution - 0229
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Local Institution - 0174
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Local Institution - 0016
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Local Institution - 0017
      • Monroe, Louisiana, United States, 71203
        • Local Institution - 0125
    • Maryland
      • Baltimore, Maryland, United States, 21224-2746
        • Local Institution - 0187
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Local Institution - 0173
    • Minnesota
      • Eagan, Minnesota, United States, 55123
        • Local Institution - 0131
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Local Institution - 0138
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Local Institution - 0009
    • New York
      • Mineola, New York, United States, 11501
        • Local Institution - 0184
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Local Institution - 0224
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Local Institution - 0130
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Local Institution - 0022
    • Texas
      • Allen, Texas, United States, 75013
        • Local Institution - 0144
      • Katy, Texas, United States, 77494
        • Local Institution - 0227
      • Plano, Texas, United States, 75024
        • Local Institution - 0175
    • Washington
      • Seattle, Washington, United States, 98195
        • Local Institution - 0133
      • Spokane, Washington, United States, 99204
        • Local Institution - 0189

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Deucravacitinib, Dose 1
Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165
Experimental: Deucravacitinib, Dose 2
Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165
Placebo Comparator: Placebo, followed by Deucravacitinib Dose 1 or Dose 2
Drug: Deucravacitinib
Specified dose on specified days
Other Names:
  • BMS-986165
Other: Placebo
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI) Score at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Number of participants with decrease in ESSPRI ≥ 1 or 15% from baseline at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Number of participants with decrease in ESSDAI ≥ 3 points from baseline at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Number of participants with ESSDAI < 5 at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from baseline in ESSDAI at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24
Change from baseline in stimulated whole salivary flow (SWSF) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from baseline in physician global assessment (PhGA) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from baseline in functional assessment of chronic illness therapy (FACIT)-fatigue at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from baseline in ocular dryness numeric rating scale (NRS) at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from baseline in oral dryness NRS at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from baseline in joint/ muscle pain NRS at Week 52
Time Frame: Baseline, Week 52
Baseline, Week 52
Number of participants with adverse events (AEs)
Time Frame: Up to Week 160
Up to Week 160
Number of participants with serious AEs (SAEs)
Time Frame: Up to Week 160
Up to Week 160
Number of participants with AEs leading to discontinuation of treatment and study discontinuation
Time Frame: Up to Week 160
Up to Week 160
Number of participants with AEs of special interest (AESIs)
Time Frame: Up to Week 160
Up to Week 160
Number of participants with clinical laboratory abnormalities
Time Frame: Up to Week 160
Up to Week 160
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to Week 156
Up to Week 156
Number of participants with vital sign abnormalities
Time Frame: Up to Week 160
Up to Week 160
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
Baseline, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 18, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 16, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IM011-1069
  • 2023-503327-26 (Registry Identifier: EU Clinical Trial Number)
  • U111-1289-6072 (Registry Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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