A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)

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-1)

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): 516
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1123
    • Local Institution - 0032
  • Buenos Aires, Argentina, C1023AAB
    • Local Institution - 0240
  • Buenos Aires, Argentina, C1221ADC
    • Local Institution - 0022
  • Buenos Aires, Argentina, CP1280AEB
    • Local Institution - 0140
  • Córdoba, Argentina, 5004
    • Local Institution - 0138
  • Mendoza, Argentina, 5500
    • Local Institution - 0017
  • Buenos Aires
    • Quilmes, Buenos Aires, Argentina, 1878
      • Local Institution - 0078
  • Buenos Aires F.D.
    • Buenos Aires, Buenos Aires F.D., Argentina, C1121ABE
      • Local Institution - 0013
    • CABA, Buenos Aires F.D., Argentina, 1406
      • Local Institution - 0020
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Local Institution - 0123
• Brazil
  • Rio de Janeiro, Brazil, 20551-030
    • Local Institution - 0186
  • São Paulo, Brazil, 05403-000
    • Local Institution - 0125
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 40150-150
      • Local Institution - 0224
  • Federal District
    • Lago Sul, Federal District, Brazil, 71635580
      • Local Institution - 0096
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Local Institution - 0042
    • Juiz de Fora, Minas Gerais, Brazil, 36010-570
      • Local Institution - 0041
  • Paraná
    • Curitiba, Paraná, Brazil, 80730-150
      • Local Institution - 0190
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610000
      • Local Institution - 0181
  • São Paulo
    • Campinas, São Paulo, Brazil, 13015-001
      • Local Institution - 0185
    • Ribeirão Preto, São Paulo, Brazil, 14051-140
      • Local Institution - 0187
    • São José do Rio Preto, São Paulo, Brazil, 15090000
      • Local Institution - 0066
    • São Paulo, São Paulo, Brazil, 04038-002
      • Local Institution - 0191
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Local Institution - 0163
  • Sofia, Bulgaria, 1407
    • Local Institution - 0217
  • Sofia, Bulgaria, 1784
    • Local Institution - 0162
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Local Institution - 0126
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • Local Institution - 0160
    • London, Ontario, Canada, N6A 4V2
      • Local Institution - 0114
    • Toronto, Ontario, Canada, M5T 2S8
      • Local Institution - 0115
  • Quebec
    • Rimouski, Quebec, Canada, G5L 5T1
      • Local Institution - 0136
• China
  • Taiyuan, China, 030032
    • Local Institution - 0158
  • Anhui
    • Bengbu, Anhui, China, 233017
      • Local Institution - 0110
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Local Institution - 0070
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Local Institution - 0107
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Local Institution - 0029
    • Guangzhou, Guangdong, China, 510120
      • Local Institution - 0080
    • Guangzhou, Guangdong, China, 510080
      • Local Institution - 0051
    • Shenzhen, Guangdong, China, 518020
      • Local Institution - 0037
  • Hebei
    • Baoding, Hebei, China, 071030
      • Local Institution - 0153
  • Henan
    • Luoyang, Henan, China, 471003
      • Local Institution - 0133
    • Zhengzhou, Henan, China, 450000
      • Local Institution - 0023
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Local Institution - 0137
  • Hunan
    • Changsha, Hunan, China, 410008
      • Local Institution - 0044
    • Zhuzhou, Hunan, China, 412007
      • Local Institution - 0021
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010050
      • Local Institution - 0089
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Local Institution - 0129
  • Jiangxi
    • Jiujiang, Jiangxi, China, 332000
      • Local Institution - 0031
    • Nanchang, Jiangxi, China, 330006
      • Local Institution - 0071
    • Nanchang, Jiangxi, China, 330006
      • Local Institution - 0117
    • Nanchang, Jiangxi, China, 330006
      • Local Institution - 0220
    • Pingxiang, Jiangxi, China, 337055
      • Local Institution - 0028
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Local Institution - 0092
    • Shenyang, Liaoning, China, 110001
      • Local Institution - 0039
  • Shandong
    • Jinan, Shandong, China, 250001
      • Local Institution - 0149
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Local Institution - 0079
    • Shanghai, Shanghai Municipality, China, 200040
      • Local Institution - 0045
    • Shanghai, Shanghai Municipality, China, 200127
      • Local Institution - 0049
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Local Institution - 0116
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Local Institution - 0053
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830001
      • Local Institution - 0043
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Local Institution - 0132
    • Wenzhou, Zhejiang, China, 325000
      • Local Institution - 0135
• Colombia
  • Bogotá, Colombia, 110221
    • Local Institution - 0100
  • Bogotá, Colombia, 110231
    • Local Institution - 0170
  • Cali, Colombia, 760035
    • Local Institution - 0093
  • Chía, Colombia, 250001
    • Local Institution - 0057
  • Antioquia
    • Medellín, Antioquia, Colombia, 050021
      • Local Institution - 0174
  • Atlántico
    • Barranquilla, Atlántico, Colombia, 080002
      • Local Institution - 0056
  • Santander Department
    • Bucaramanga, Santander Department, Colombia, 680003
      • Local Institution - 0086
• France
  • Le Kremlin-Bicêtre, France, 94270
    • Local Institution - 0173
  • Tours, France, 37032
    • Local Institution - 0156
  • Alsace
    • Strasbourg, Alsace, France, 67091
      • Local Institution - 0150
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093 Cedex 1
      • Local Institution - 0068
• Germany
  • Chemnitz, Germany, 09117
    • Local Institution - 0195
  • Cologne, Germany, 50937
    • Local Institution - 0061
  • Erlangen, Germany, 91054
    • Local Institution - 0120
  • Planegg, Germany, 82152
    • Local Institution - 0111
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Local Institution - 0109
  • Bavaria
    • Munich, Bavaria, Germany, 80336
      • Local Institution - 0176
  • Saxony
    • Dresden, Saxony, Germany, 01307
      • Local Institution - 0146
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Local Institution - 0151
• Hong Kong
  • Tuenmen, Hong Kong, 999077
    • Local Institution - 0067
• India
  • Andhra Pradesh
    • Vizianagaram, Andhra Pradesh, India
      • Local Institution - 0213
  • Gujarat
    • Ahmedabad, Gujarat, India, 380015
      • Local Institution - 0200
    • Surat, Gujarat, India, 395010
      • Local Institution - 0243
  • Haryana
    • Gurugram, Haryana, India, 122001
      • Local Institution - 0208
  • Karnataka
    • Bengaluru, Karnataka, India, 560010
      • Local Institution - 0202
  • Telangana
    • Hyderabad, Telangana, India, 500038
      • Local Institution - 0222
    • Hyderabad, Telangana, India, 500082
      • Local Institution - 0205
• Ireland
  • Cork, Ireland, T12 E8YV
    • Local Institution - 0130
  • Dublin, Ireland, D08 E9P6
    • Local Institution - 0157
  • Dublin, Ireland, D15 X40D
    • Local Institution - 0172
  • Leitrim
    • Manorhamilton, Leitrim, Ireland
      • Local Institution - 0119
• Italy
  • Brescia, Italy, 25123
    • Local Institution - 0069
  • Milan, Italy, 20132
    • Local Institution - 0072
  • Napoli, Italy, 80131
    • Local Institution - 0154
  • Verona, Italy, 37134
    • Local Institution - 0161
  • Lazio
    • Rome, Lazio, Italy, 00161
      • Local Institution - 0084
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Local Institution - 0095
  • Tuscany
    • Pisa, Tuscany, Italy, 56126
      • Local Institution - 0060
  • Veneto
    • Padua, Veneto, Italy, 35128
      • Local Institution - 0097
• Lithuania
  • Kaunas County
    • Kaunas, Kaunas County, Lithuania, LT-50161
      • Local Institution - 0167
• Mexico
  • Chihuahua City, Mexico, 31000
    • Local Institution - 0018
  • Puebla City, Mexico, 72160
    • Local Institution - 0083
  • Estado de Baja California
    • Mexicali, Estado de Baja California, Mexico, 21100
      • Local Institution - 0015
  • Guanajuato
    • León, Guanajuato, Mexico, 37000
      • Local Institution - 0082
  • Jalisco
    • Zapopan, Jalisco, Mexico, 45116
      • Local Institution - 0024
  • Mexico City
    • Mexico City, Mexico City, Mexico, 01120
      • Local Institution - 0026
    • Mexico City, Mexico City, Mexico, 03720
      • Local Institution - 0027
    • Mexico City, Mexico City, Mexico, 06700
      • Local Institution - 0016
    • Mexico City, Mexico City, Mexico, 06700
      • Local Institution - 0050
    • Mexico City, Mexico City, Mexico, 14080
      • Local Institution - 0112
• Moldova
  • Chisinau, Moldova, 2025
    • Local Institution - 0236
  • Chișinău
    • Chisinau, Chișinău, Moldova, MD-2051
      • Local Institution - 0238
• Peru
  • Arequipa, Peru, 05154
    • Local Institution - 0199
  • Lima, Peru, 15046
    • Local Institution - 0104
  • Lima, Peru, 15047
    • Local Institution - 0122
  • Lima, Peru, 33
    • Local Institution - 0103
• Poland
  • Bialystok, Poland, 15-707
    • Local Institution - 0035
  • Lublin, Poland, 20-362
    • Velocity Clinical Research, Lublin
  • Poznan, Poland, 60-702
    • Local Institution - 0212
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-218
      • Local Institution - 0036
  • Kuyavian-Pomeranian Voivodeship
    • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-168
      • Local Institution - 0040
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-363
      • Local Institution - 0033
  • Masovian Voivodeship
    • Nadarzyn, Masovian Voivodeship, Poland, 05-830
      • Local Institution - 0034
    • Warsaw, Masovian Voivodeship, Poland, 02-118
      • Local Institution - 0164
    • Warsaw, Masovian Voivodeship, Poland, 02-637
      • Local Institution - 0166
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-081
      • Local Institution - 0047
  • Łódź Voivodeship
    • Bełchatów, Łódź Voivodeship, Poland, 97-400
      • Local Institution - 0211
• Puerto Rico
  • Caguas, Puerto Rico, 00725
    • Local Institution - 0203
  • San Juan, Puerto Rico, 00909
    • Local Institution - 0252
  • San Juan, Puerto Rico, 00917
    • Local Institution - 0197
• Romania
  • Timișoara, Romania, 300766
    • Local Institution - 0143
  • București
    • Bucharest, București, Romania, 011172
      • Local Institution - 0076
    • Bucharest, București, Romania, 011053
      • Local Institution - 0148
    • Bucharest, București, Romania, 014142
      • Local Institution - 0152
    • Bucharest, București, Romania, 020125
      • Local Institution - 0141
    • Bucharest, București, Romania, 041303
      • Local Institution - 0215
    • Bucharest, București, Romania, 30463
      • Local Institution - 0210
  • Dolj
    • Craiova, Dolj, Romania, 200347
      • Local Institution - 0142
  • Iaşi
    • Iași, Iaşi, Romania, 700127
      • Local Institution - 0216
  • Vâlcea County
    • Râmnicu Vâlcea, Vâlcea County, Romania, 247065
      • Local Institution - 0094
• South Korea
  • Seoul, South Korea, 04763
    • Local Institution - 0169
  • Kwangju-Kwangyǒkshi
    • Gwangju, Kwangju-Kwangyǒkshi, South Korea, 61469
      • Local Institution - 0102
  • Kyǒnggi-do
    • Suwon, Kyǒnggi-do, South Korea, 16499
      • Local Institution - 0101
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06591
      • Local Institution - 0144
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06560
    • Local Institution - 0184
  • Istanbul, Turkey (Türkiye), 34098
    • Local Institution - 0168
  • Kocaeli, Turkey (Türkiye), 41380
    • Local Institution - 0189
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Local Institution - 0012
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Local Institution - 0229
    • Tucson, Arizona, United States, 85724
      • Local Institution - 0193
  • California
    • Fontana, California, United States, 92335
      • Kaiser Permanente
    • La Mesa, California, United States, 91942
      • Local Institution - 0247
    • La Palma, California, United States, 90623
      • Local Institution - 0090
    • Los Angeles, California, United States, 90095
      • Local Institution - 0124
    • Sacramento, California, United States, 95817
      • Local Institution - 0248
    • San Diego, California, United States, 92128
      • Local Institution - 0253
    • Santa Barbara, California, United States, 93108
      • Local Institution - 0128
  • Colorado
    • Denver, Colorado, United States, 80230
      • Local Institution - 0099
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Local Institution - 0054
  • Florida
    • Coral Springs, Florida, United States, 33065
      • Local Institution - 0249
    • Gainesville, Florida, United States, 32610
      • Local Institution - 0010
    • Miami, Florida, United States, 33136
      • Local Institution - 0087
    • Orlando, Florida, United States, 32806
      • Local Institution - 0007
    • Plantation, Florida, United States, 33317
      • Local Institution - 0242
    • Tamarac, Florida, United States, 33321
      • Local Institution - 0002
    • Tampa, Florida, United States, 33614
      • Local Institution - 0165
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Local Institution - 0204
    • Lawrenceville, Georgia, United States, 30044
      • Local Institution - 0228
    • Lawrenceville, Georgia, United States, 30046
      • Local Institution - 0147
  • Illinois
    • Morton Grove, Illinois, United States, 60053
      • Local Institution - 0227
    • Schaumburg, Illinois, United States, 60195
      • Local Institution - 0077
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Local Institution - 0108
    • New Albany, Indiana, United States, 47150
      • Lake Cumberland Rheumatology
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Local Institution - 0225
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Local Institution - 0006
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • Local Institution - 0179
  • New Jersey
    • Summit, New Jersey, United States, 07901
      • Local Institution - 0177
  • New York
    • Manhasset, New York, United States, 11030
      • Local Institution - 0180
    • New York, New York, United States, 10016
      • Local Institution - 0085
    • Rochester, New York, United States, 14642
      • Local Institution - 0098
    • The Bronx, New York, United States, 10467
      • Local Institution - 0159
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Local Institution - 0245
    • Charlotte, North Carolina, United States, 28211
      • Local Institution - 0155
  • South Carolina
    • Summerville, South Carolina, United States, 29486
      • Local Institution - 0246
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Local Institution - 0003
  • Texas
    • Allen, Texas, United States, 75013
      • Local Institution - 0064
    • Dallas, Texas, United States, 75390
      • Local Institution - 0065
    • Fort Worth, Texas, United States, 76177
      • Local Institution - 0088
    • Houston, Texas, United States, 77090
      • Local Institution - 0250
    • Lubbock, Texas, United States, 79415
      • Local Institution - 0219
    • The Woodlands, Texas, United States, 77382
      • Local Institution - 0005
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Local Institution - 0009
  • Washington
    • Seattle, Washington, United States, 98122
      • Local Institution - 0011
    • Seattle, Washington, United States, 98195
      • Local Institution - 0139
  • Wisconsin
    • Franklin, Wisconsin, United States, 53132
      • Local Institution - 0063

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.
• 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: Double

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 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 26, 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: IM011-246; 2022-500699-76 (Other Identifier: EU CTR)

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