A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (POETYK SLE-2)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-2)

The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

Study Overview

• Status: Active, not recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Deucravacitinib; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 513
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Ciudad de Buenos Aires, Buenos Aires, Argentina, 1180
      • Local Institution - 0146
    • La Plata, Buenos Aires, Argentina, 1900
      • Local Institution - 0088
    • Pergamino, Buenos Aires, Argentina, B2700
      • Local Institution - 0078
    • Pilar, Buenos Aires, Argentina, 1629
      • Local Institution - 0125
    • San Juan Bautista, Buenos Aires, Argentina, 1888
      • Local Institution - 0020
    • San Miguel, Buenos Aires, Argentina, 1663
      • Local Institution - 0136
  • Buenos Aires F.D.
    • Quilmes, Buenos Aires F.D., Argentina, 1879
      • Local Institution - 0018
  • Tucumán Province
    • SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
      • Local Institution - 0013
    • San Miguel de Tucumán, Tucumán Province, Argentina, T4000
      • Local Institution - 0027
• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Local Institution - 0179
    • Paramatta, New South Wales, Australia, 2150
      • Local Institution - 0182
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Local Institution - 0066
  • Victoria
    • Ivanhoe, Victoria, Australia, 3079
      • Local Institution - 0177
  • Western Australia
    • Victoria Park, Western Australia, Australia, 6100
      • Local Institution - 0129
• Brazil
  • Rio de Janeiro, Brazil, 22061-080
    • Local Institution - 0087
  • São Paulo, Brazil, 01327-001
    • Local Institution - 0161
  • São Paulo, Brazil, 01409-901
    • Local Institution - 0062
  • São Paulo, Brazil, 04266-010
    • Local Institution - 0190
  • Espírito Santo
    • Vitória, Espírito Santo, Brazil, 29055450
      • Local Institution - 0160
  • Rio Grande do Sul
    • Lajeado, Rio Grande do Sul, Brazil, 95900-000
      • Local Institution - 0028
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Local Institution - 0154
    • Porto Alegre, Rio Grande do Sul, Brazil, 90560032
      • Local Institution - 0023
  • Rondônia
    • Porto Velho, Rondônia, Brazil, 76801-098
      • Local Institution - 0230
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784400
      • Local Institution - 0175
    • São Bernardo do Campo, São Paulo, Brazil, 09715-090
      • Local Institution - 0115
• Bulgaria
  • Plovdiv, Bulgaria, 4001
    • Local Institution - 0158
  • Rousse, Bulgaria, 7002
    • Local Institution - 0159
  • Sofia (stolitsa)
    • Sofia, Sofia (stolitsa), Bulgaria, 1463
      • Local Institution - 0163
• Chile
  • Santiago, Chile, 7550000
    • Local Institution - 0153
  • Coquimbo Region
    • La Serena, Coquimbo Region, Chile, 1720430
      • Local Institution - 0139
  • Santiago Metropolitan
    • Santiago, Santiago Metropolitan, Chile, 7500571
      • Local Institution - 0220
    • Santiago, Santiago Metropolitan, Chile, 7500710
      • Local Institution - 0101
    • Santiago, Santiago Metropolitan, Chile, 7501126
      • Local Institution - 0183
    • Santiago, Santiago Metropolitan, Chile, 8330032
      • Local Institution - 0140
    • Santiago, Santiago Metropolitan, Chile, 8380465
      • Local Institution - 0203
• Czechia
  • Prague, Czechia, 12850
    • Local Institution - 0036
  • Ostrava Město
    • Ostrava, Ostrava Město, Czechia, 70300
      • Local Institution - 0174
• Greece
  • Attikí
    • Athens, Attikí, Greece, 11527
      • Local Institution - 0116
  • Attikí (Region)
    • Athens, Attikí (Region), Greece, 115 27
      • Local Institution - 0123
  • Thessalía
    • Larissa, Thessalía, Greece, 411 10
      • Local Institution - 0138
• Hungary
  • Baranya
    • Pécs, Baranya, Hungary, 7632
      • Local Institution - 0057
  • Bekes County
    • Gyula, Bekes County, Hungary, 5700
      • Local Institution - 0035
  • Csongrád megye
    • Szeged, Csongrád megye, Hungary, 6725
      • Local Institution - 0134
  • Veszprém City
    • Veszprém, Veszprém City, Hungary, 8200
      • Local Institution - 0034
• India
  • Gujarat
    • Ahmedabad, Gujarat, India, 380013
      • Local Institution - 0234
    • Ahmedabad, Gujarat, India, 382443
      • Local Institution - 0233
  • Karnataka
    • Hubli, Karnataka, India, 580021
      • Local Institution - 0191
    • Mysore, Karnataka, India, 570004
      • Local Institution - 0222
  • Maharashtra
    • Nagpur, Maharashtra, India, 440012
      • Local Institution - 0229
  • Tamil Nadu
    • Vellore, Tamil Nadu, India, 632 004
      • Local Institution - 0210
  • Telangana
    • Hyderabad, Telangana, India, 500016
      • Local Institution - 0235
    • Secundarabad, Telangana, India, 500003
      • Local Institution - 0199
• Japan
  • Fukuoka, Japan, 812-8582
    • Local Institution - 0227
  • Fukushima, Japan, 960-1295
    • Local Institution - 0050
  • Gifu, Japan, 501-1112
    • Local Institution - 0167
  • Nagasaki, Japan, 852-8501
    • Local Institution - 0126
  • Niigata, Japan, 951-8520
    • Local Institution - 0131
  • Okayama, Japan, 700-8558
    • Local Institution - 0085
  • Osaka, Japan, 545-8586
    • Local Institution - 0108
  • Tokyo, Japan, 104-8560
    • Local Institution - 0054
  • Tokyo, Japan, 1608582
    • Local Institution - 0051
  • Wakayama, Japan, 641-8510
    • Local Institution - 0148
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 457-8511
      • Local Institution - 0053
    • Nagoya, Aichi-ken, Japan, 466-8560
      • Local Institution - 0156
    • Toyoake, Aichi-ken, Japan, 470-1192
      • Local Institution - 0083
  • Chiba
    • Chiba, Chiba, Japan, 260-8712
      • Local Institution - 0047
  • Fukui
    • Eiheiji-cho,Yoshida-gun, Fukui, Japan, 910-1193
      • Local Institution - 0086
  • Fukuoka
    • Kitakyushu, Fukuoka, Japan, 807-8556
      • Local Institution - 0117
  • Hokkaido
    • Asahikawa, Hokkaido, Japan, 0708644
      • Local Institution - 0082
    • Sapporo, Hokkaido, Japan, 0608648
      • Local Institution - 0048
  • Kagawa-ken
    • Kita, Kagawa-ken, Japan, 761-0701
      • Local Institution - 0162
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0375
      • Local Institution - 0111
    • Yokohama, Kanagawa, Japan, 236-0004
      • Local Institution - 0157
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Local Institution - 0021
  • Nagasaki
    • Sasebo, Nagasaki, Japan, 8571195
      • Local Institution - 0113
  • Saitama
    • Kawagoe, Saitama, Japan, 350-8550
      • Local Institution - 0022
  • Tochigi
    • Shimotsuga, Tochigi, Japan, 321-0293
      • Local Institution - 0171
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8519
      • Local Institution - 0173
    • Bunkyo-ku, Tokyo, Japan, 1138431
      • Local Institution - 0046
    • Meguro-ku, Tokyo, Japan, 1538515
      • Local Institution - 0045
    • Shinjyuku-ku, Tokyo, Japan, 162-8655
      • Local Institution - 0064
  • Toyama
    • Toyoma, Toyama, Japan, 930-0194
      • Local Institution - 0226
• Mexico
  • Chihuahua City, Mexico, 31350
    • Local Institution - 0106
  • Oaxaca City, Mexico, 68000
    • Local Institution - 0074
  • Coahuila
    • Torreón, Coahuila, Mexico, 27000
      • Local Institution - 0107
  • Guanajuato
    • León, Guanajuato, Mexico, 37160
      • Local Institution - 0009
  • Jalisco
    • Guadajalara, Jalisco, Mexico, 44600
      • Local Institution - 0077
    • Zapopan, Jalisco, Mexico, 45070
      • Local Institution - 0026
  • Mexico City
    • Mexico City, Mexico City, Mexico, 03100
      • Local Institution - 0024
    • Mexico City, Mexico City, Mexico, 06760
      • Local Institution - 0011
  • Morelos
    • Cuernavaca, Morelos, Mexico, 62290
      • Local Institution - 0010
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64020
      • Local Institution - 0124
• Peru
  • Lima, Peru, 15419
    • Local Institution - 0118
  • Lima, Peru, 15046
    • Local Institution - 0208
  • Lima, Peru, 15072
    • Local Institution - 0176
  • Lima, Peru, LIMA 31
    • Local Institution - 0121
• Poland
  • Szczecin, Poland, 71-252
    • Local Institution - 0071
  • Warsaw, Poland, 00-874
    • Local Institution - 0014
  • Wroclaw, Poland, 52-416
    • Local Institution - 0031
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-545
      • Local Institution - 0017
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-727
      • Local Institution - 0029
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-607
      • Local Institution - 0186
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 02-665
      • Local Institution - 0219
    • Warsaw, Masovian Voivodeship, Poland, 02-672
      • Local Institution - 0185
    • Warsaw, Masovian Voivodeship, Poland, 03-291
      • Local Institution - 0119
  • Silesian Voivodeship
    • Chorzów, Silesian Voivodeship, Poland, 41-500
      • Local Institution - 0224
  • Warmian-Masurian Voivodeship
    • Elblag, Warmian-Masurian Voivodeship, Poland, 82-300
      • Local Institution - 0016
  • Łódź Voivodeship
    • Lodz, Łódź Voivodeship, Poland, 90-368
      • Local Institution - 0187
• Portugal
  • Lisbon, Portugal, 2720-276
    • Local Institution - 0073
  • Lisbon, Portugal, 1050-034
    • Local Institution - 0144
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1649-035
      • Local Institution - 0105
  • Porto District
    • Vila Nova de Gaia, Porto District, Portugal, 4434-502
      • Local Institution - 0109
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Local Institution - 0240
  • San Juan, Puerto Rico, 00909
    • Local Institution - 0194
• Singapore
  • Singapore, Singapore, 169608
    • Local Institution - 0135
  • Singapore, Singapore, 529889
    • Local Institution - 0127
• Spain
  • Seville, Spain, 41010
    • Local Institution - 0052
  • Valencia, Spain, 46026
    • Local Institution - 0058
  • Valladolid, Spain, 47012
    • Local Institution - 0067
  • Badajoz
    • Mérida, Badajoz, Spain, 06800
      • Local Institution - 0151
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Local Institution - 0038
  • Basque Country
    • Bilbao, Basque Country, Spain, 48013
      • Local Institution - 0110
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Local Institution - 0061
  • Madrid
    • Cordoba, Madrid, Spain, 14004
      • Local Institution - 0103
• Taiwan
  • Taichung, Taiwan, 404332
    • Local Institution - 0065
  • Taichung, Taiwan, 407
    • Local Institution - 0114
  • Tainan, Taiwan, 71004
    • Local Institution - 0039
  • Taipei, Taiwan, 10002
    • Local Institution - 0181
  • Taipei, Taiwan, 11217
    • Local Institution - 0122
  • Kaohsiung
    • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
      • Local Institution - 0094
  • Taichung
    • Taichung, Taichung, Taiwan, 402
      • Local Institution - 0040
• Thailand
  • Bangkok
    • Bangkok, Bangkok, Thailand, 10400
      • Local Institution - 0212
    • Bangkok, Bangkok, Thailand, 10700
      • Local Institution - 0211
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • Local Institution - 0184
  • Antalya, Turkey (Türkiye), 07059
    • Local Institution - 0166
  • Gaziantep, Turkey (Türkiye), 27090
    • Local Institution - 0188
• United Kingdom
  • Oxford, United Kingdom, OX3 7LD
    • Local Institution - 0130
  • England
    • London, England, United Kingdom, NW32QG
      • Local Institution - 0223
  • Greater London
    • London, Greater London, United Kingdom, SE5 9RS
      • Local Institution - 0090
  • London, City of
    • London, London, City of, United Kingdom, SE1 9RT
      • Local Institution - 0091
  • Middlesbrough
    • Central Middlesbrough, Middlesbrough, United Kingdom, TS4 3BW
      • Local Institution - 0168
• United States
  • California
    • La Jolla, California, United States, 92037
      • Local Institution - 0063
    • La Mesa, California, United States, 91942
      • Local Institution - 0241
    • San Diego, California, United States, 92128
      • Local Institution - 0242
    • San Leandro, California, United States, 94578
      • Local Institution - 0143
    • Santa Monica, California, United States, 90404
      • Local Institution - 0147
  • Florida
    • Clearwater, Florida, United States, 33765
      • Local Institution - 0213
    • Jacksonville, Florida, United States, 32256
      • Local Institution - 0059
    • Margate, Florida, United States, 33063
      • Local Institution - 0075
    • Oakland Park, Florida, United States, 33334
      • Local Institution - 0007
    • Plant City, Florida, United States, 33160
      • Local Institution - 0239
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University School of Medicine- Grady Campus
    • Marietta, Georgia, United States, 30060
      • Local Institution - 0137
  • Illinois
    • Orland Park, Illinois, United States, 60467
      • Local Institution - 0089
    • Skokie, Illinois, United States, 60076
      • Local Institution - 0041
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Local Institution - 0231
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0056
    • Boston, Massachusetts, United States, 02114
      • Local Institution - 0060
    • Worcester, Massachusetts, United States, 01605
      • Local Institution - 0084
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Local Institution - 0152
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Local Institution - 0072
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Local Institution - 0216
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • Local Institution - 0165
  • New York
    • Brooklyn, New York, United States, 11201
      • Local Institution - 0069
    • Great Neck, New York, United States, 11021
      • Local Institution - 0217
    • New York, New York, United States, 10021
      • Local Institution - 0150
    • New York, New York, United States, 10032
      • Local Institution - 0102
    • Syracuse, New York, United States, 13210
      • Local Institution - 0145
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Local Institution - 0178
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Local Institution - 0005
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Local Institution - 0043
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Local Institution - 0205
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Local Institution - 0081
    • Florence, South Carolina, United States, 29501
      • Local Institution - 0225
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Local Institution - 0002
  • Texas
    • Colleyville, Texas, United States, 76034
      • Local Institution - 0001
    • El Paso, Texas, United States, 79902
      • Local Institution - 0164
    • Katy, Texas, United States, 77494
      • Local Institution - 0169
    • Temple, Texas, United States, 76508
      • Local Institution - 0201
  • Virginia
    • Danville, Virginia, United States, 24541
      • Local Institution - 0133

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit.
• Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE.
• One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening.
• Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash.
• Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry.
• At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation.
• Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant.

Exclusion Criteria

• Diagnosis of drug-induced SLE rather than idiopathic SLE.
• Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded -SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded.
• Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria.
• Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS.
• History of congenital or acquired immunodeficiency.
• Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization -Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria).
• Taking more than 1 immunosuppressant at screening.
• In Japan only: Participants with positive result of β - D-glucan assay.
• 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Deucravacitinib	Drug: Deucravacitinib; Specified dose on specified days
Placebo Comparator: Arm 2: Placebo	Other: Placebo; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response	At week 52

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response	At week 52
Proportion of participants who achieve both SRI(4) and BICLA (dual responders)	At week 52
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score	At week 52
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)	At week 52
Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints	At week 52
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue	At week 52
Number of participants with adverse events (AEs)	Up to 156 weeks
Number of participants with serious adverse events (SAEs)	Up to 156 weeks
Number of participants with AEs leading to discontinuation of treatment	Up to 156 weeks
Number of participants with AEs leading to study discontinuation	Up to 156 weeks
Number of participants with laboratory abnormalities	Up to 156 weeks
Number of participants with electrocardiogram (ECG) abnormalities	Up to 156 weeks
Number of participants with vital sign abnormalities	Up to 156 weeks
Number of participants with target adverse events of special interest (AESIs)	Up to 156 weeks
Proportion of participants with oral corticosteroid (OCS) ≥ 7.5 mg/day of prednisone at baseline who are receiving ≤ 5 mg/day of prednisone at Week (Wk) 40 which is maintained through Wk52 and who achieve an SRI(4) response at Wk52	At week 52

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Arriens C, Morand EF, Askanase AD, Furie R, van Vollenhoven RF, Tanaka Y, Connors K, Davey M, Young K, Franchin G, Meier R, Shah V, de Oliveria CL, Hobar C. Design of Two Randomized, Placebo-Controlled, Phase 3 Trials of Deucravacitinib, an Oral, Selective, Allosteric TYK2 Inhibitor, in Systemic Lupus Erythematosus. Adv Ther. 2025 Nov;42(11):5830-5844. doi: 10.1007/s12325-025-03299-0. Epub 2025 Sep 8.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): November 13, 2028

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Lupus; Immune System Diseases; Connective Tissue Diseases; SLE; Autoimmune Diseases; Deucravacitinib; Active Systemic Lupus Erythematosus; Immune-mediated Diseases; Tyk2; POETYK; POETYK SLE
• Additional Relevant MeSH Terms: Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Autoimmune Diseases; Immune System Diseases; Connective Tissue Diseases; Substandard Drugs; Pharmaceutical Preparations; deucravacitinib
• Other Study ID Numbers: IM011-247; 2022-500700-22 (Other Identifier: EU CT Number)

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/disclosurecommitment.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