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

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: Active, not recruiting
• Conditions: Sjögren's Syndrome
• Intervention / Treatment: Drug: Deucravacitinib; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 774
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	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
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 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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): November 16, 2028

Study Registration Dates

• First Submitted: July 7, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Deucravacitinib; BMS-986165; Sjogren's Syndrome; Sjogren; Sjogren Syndrome; POETYK; Sjogren's; Sjogren-Larson Syndrome; Gougerot-Sjogren; Gougerot Sjogren Syndrome; Sjogren Disease; Sjogren's Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome; Substandard Drugs; Pharmaceutical Preparations; deucravacitinib
• Other Study ID 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