A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
NCT ID: NCT05617677
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
516 participants
INTERVENTIONAL
2023-01-12
2028-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1: Deucravacitinib
Deucravacitinib
Specified dose on specified days
Arm 2: Placebo
Placebo
Specified dose on specified days
Interventions
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Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0165
Tampa, Florida, United States
Local Institution - 0204
Atlanta, Georgia, United States
Local Institution - 0107
Xiamen, Fujian, China
Local Institution - 0029
Guangzhou, Guangdong, China
Local Institution - 0051
Guangzhou, Guangdong, China
Local Institution - 0080
Guangzhou, Guangdong, China
Local Institution - 0037
Shenzhen, Guangdong, China
Local Institution - 0153
Baoding, Hebei, China
Local Institution - 0133
Luoyang, Henan, China
Local Institution - 0023
Zhengzhou, Henan, China
Local Institution - 0137
Wuhan, Hubei, China
Local Institution - 0044
Changsha, Hunan, China
Local Institution - 0021
Zhuzhou, Hunan, China
Local Institution - 0089
Hohhot, Inner Mongolia, China
Local Institution - 0129
Changzhou, Jiangsu, China
Local Institution - 0031
Jiujiang, Jiangxi, China
Local Institution - 0071
Nanchang, Jiangxi, China
Local Institution - 0117
Nanchang, Jiangxi, China
Local Institution - 0220
Nanchang, Jiangxi, China
Local Institution - 0028
Pingxiang, Jiangxi, China
Local Institution - 0039
Shenyang, Liaoning, China
Local Institution - 0092
Shenyang, Liaoning, China
Local Institution - 0149
Jinan, Shandong, China
Local Institution - 0122
Lima, , Peru
Local Institution - 0103
Lima, , Peru
Local Institution - 0036
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0040
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0033
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0034
Nadarzyn, Masovian Voivodeship, Poland
Local Institution - 0164
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0166
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0047
Katowice, Silesian Voivodeship, Poland
Local Institution - 0035
Bialystok, , Poland
Velocity Clinical Research, Lublin
Lublin, , Poland
Local Institution - 0212
Poznan, , Poland
Local Institution - 0211
Bełchatów, Łódź Voivodeship, Poland
Local Institution - 0203
Caguas, , Puerto Rico
Local Institution - 0252
San Juan, , Puerto Rico
Local Institution - 0197
San Juan, , Puerto Rico
Local Institution - 0148
Bucharest, București, Romania
Local Institution - 0076
Bucharest, București, Romania
Local Institution - 0152
Bucharest, București, Romania
Local Institution - 0141
Bucharest, București, Romania
Local Institution - 0215
Bucharest, București, Romania
Local Institution - 0210
Bucharest, București, Romania
Local Institution - 0142
Craiova, Dolj, Romania
Local Institution - 0216
Iași, Iaşi, Romania
Local Institution - 0012
Birmingham, Alabama, United States
Local Institution - 0229
Phoenix, Arizona, United States
Local Institution - 0193
Tucson, Arizona, United States
Kaiser Permanente
Fontana, California, United States
Local Institution - 0247
La Mesa, California, United States
Local Institution - 0090
La Palma, California, United States
Local Institution - 0124
Los Angeles, California, United States
Local Institution - 0248
Sacramento, California, United States
Local Institution - 0253
San Diego, California, United States
Local Institution - 0128
Santa Barbara, California, United States
Local Institution - 0099
Denver, Colorado, United States
Local Institution - 0054
New Haven, Connecticut, United States
Local Institution - 0249
Coral Springs, Florida, United States
Local Institution - 0010
Gainesville, Florida, United States
Local Institution - 0087
Miami, Florida, United States
Local Institution - 0007
Orlando, Florida, United States
Local Institution - 0242
Plantation, Florida, United States
Local Institution - 0002
Tamarac, Florida, United States
Local Institution - 0228
Lawrenceville, Georgia, United States
Local Institution - 0147
Lawrenceville, Georgia, United States
Local Institution - 0227
Morton Grove, Illinois, United States
Local Institution - 0077
Schaumburg, Illinois, United States
Local Institution - 0108
Indianapolis, Indiana, United States
Lake Cumberland Rheumatology
New Albany, Indiana, United States
Local Institution - 0225
New Orleans, Louisiana, United States
Local Institution - 0006
Detroit, Michigan, United States
Local Institution - 0179
Eagan, Minnesota, United States
Local Institution - 0177
Summit, New Jersey, United States
Local Institution - 0180
Manhasset, New York, United States
Local Institution - 0085
New York, New York, United States
Local Institution - 0098
Rochester, New York, United States
Local Institution - 0159
The Bronx, New York, United States
Local Institution - 0245
Charlotte, North Carolina, United States
Local Institution - 0155
Charlotte, North Carolina, United States
Local Institution - 0246
Summerville, South Carolina, United States
Local Institution - 0003
Memphis, Tennessee, United States
Local Institution - 0064
Allen, Texas, United States
Local Institution - 0065
Dallas, Texas, United States
Local Institution - 0088
Fort Worth, Texas, United States
Local Institution - 0250
Houston, Texas, United States
Local Institution - 0219
Lubbock, Texas, United States
Local Institution - 0005
The Woodlands, Texas, United States
Local Institution - 0009
Roanoke, Virginia, United States
Local Institution - 0011
Seattle, Washington, United States
Local Institution - 0139
Seattle, Washington, United States
Local Institution - 0063
Franklin, Wisconsin, United States
Local Institution - 0078
Quilmes, Buenos Aires, Argentina
Local Institution - 0013
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 0020
CABA, Buenos Aires F.D., Argentina
Local Institution - 0123
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0032
Buenos Aires, , Argentina
Local Institution - 0240
Buenos Aires, , Argentina
Local Institution - 0022
Buenos Aires, , Argentina
Local Institution - 0140
Buenos Aires, , Argentina
Local Institution - 0138
Córdoba, , Argentina
Local Institution - 0017
Mendoza, , Argentina
Local Institution - 0224
Salvador, Estado de Bahia, Brazil
Local Institution - 0096
Lago Sul, Federal District, Brazil
Local Institution - 0042
Belo Horizonte, Minas Gerais, Brazil
Local Institution - 0041
Juiz de Fora, Minas Gerais, Brazil
Local Institution - 0190
Curitiba, Paraná, Brazil
Local Institution - 0181
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0185
Campinas, São Paulo, Brazil
Local Institution - 0187
Ribeirão Preto, São Paulo, Brazil
Local Institution - 0066
São José do Rio Preto, São Paulo, Brazil
Local Institution - 0191
São Paulo, São Paulo, Brazil
Local Institution - 0186
Rio de Janeiro, , Brazil
Local Institution - 0125
São Paulo, , Brazil
Local Institution - 0163
Plovdiv, , Bulgaria
Local Institution - 0217
Sofia, , Bulgaria
Local Institution - 0162
Sofia, , Bulgaria
Local Institution - 0126
Calgary, Alberta, Canada
Local Institution - 0160
Hamilton, Ontario, Canada
Local Institution - 0114
London, Ontario, Canada
Local Institution - 0115
Toronto, Ontario, Canada
Local Institution - 0136
Rimouski, Quebec, Canada
Local Institution - 0110
Bengbu, Anhui, China
Local Institution - 0070
Beijing, Beijing Municipality, China
Local Institution - 0079
Shanghai, Shanghai Municipality, China
Local Institution - 0045
Shanghai, Shanghai Municipality, China
Local Institution - 0049
Shanghai, Shanghai Municipality, China
Local Institution - 0116
Chengdu, Sichuan, China
Local Institution - 0053
Tianjin, Tianjin Municipality, China
Local Institution - 0043
Ürümqi, Xinjiang, China
Local Institution - 0132
Hangzhou, Zhejiang, China
Local Institution - 0135
Wenzhou, Zhejiang, China
Local Institution - 0158
Taiyuan, , China
Local Institution - 0174
Medellín, Antioquia, Colombia
Local Institution - 0056
Barranquilla, Atlántico, Colombia
Local Institution - 0086
Bucaramanga, Santander Department, Colombia
Local Institution - 0100
Bogotá, , Colombia
Local Institution - 0170
Bogotá, , Colombia
Local Institution - 0093
Cali, , Colombia
Local Institution - 0057
Chía, , Colombia
Local Institution - 0150
Strasbourg, Alsace, France
Local Institution - 0068
Nantes, Loire-Atlantique, France
Local Institution - 0173
Le Kremlin-Bicêtre, , France
Local Institution - 0156
Tours, , France
Local Institution - 0109
Tübingen, Baden-Wurttemberg, Germany
Local Institution - 0176
Munich, Bavaria, Germany
Local Institution - 0146
Dresden, Saxony, Germany
Local Institution - 0151
Lübeck, Schleswig-Holstein, Germany
Local Institution - 0195
Chemnitz, , Germany
Local Institution - 0061
Cologne, , Germany
Local Institution - 0120
Erlangen, , Germany
Local Institution - 0111
Planegg, , Germany
Local Institution - 0067
Tuenmen, , Hong Kong
Local Institution - 0213
Vizianagaram, Andhra Pradesh, India
Local Institution - 0200
Ahmedabad, Gujarat, India
Local Institution - 0243
Surat, Gujarat, India
Local Institution - 0208
Gurugram, Haryana, India
Local Institution - 0202
Bengaluru, Karnataka, India
Local Institution - 0222
Hyderabad, Telangana, India
Local Institution - 0205
Hyderabad, Telangana, India
Local Institution - 0119
Manorhamilton, Leitrim, Ireland
Local Institution - 0130
Cork, , Ireland
Local Institution - 0157
Dublin, , Ireland
Local Institution - 0172
Dublin, , Ireland
Local Institution - 0084
Rome, Lazio, Italy
Local Institution - 0095
Milan, Lombardy, Italy
Local Institution - 0060
Pisa, Tuscany, Italy
Local Institution - 0097
Padua, Veneto, Italy
Local Institution - 0069
Brescia, , Italy
Local Institution - 0072
Milan, , Italy
Local Institution - 0154
Napoli, , Italy
Local Institution - 0161
Verona, , Italy
Local Institution - 0167
Kaunas, Kaunas County, Lithuania
Local Institution - 0015
Mexicali, Estado de Baja California, Mexico
Local Institution - 0082
León, Guanajuato, Mexico
Local Institution - 0024
Zapopan, Jalisco, Mexico
Local Institution - 0026
Mexico City, Mexico City, Mexico
Local Institution - 0027
Mexico City, Mexico City, Mexico
Local Institution - 0016
Mexico City, Mexico City, Mexico
Local Institution - 0050
Mexico City, Mexico City, Mexico
Local Institution - 0112
Mexico City, Mexico City, Mexico
Local Institution - 0018
Chihuahua City, , Mexico
Local Institution - 0083
Puebla City, , Mexico
Local Institution - 0238
Chisinau, Chișinău, Moldova
Local Institution - 0236
Chisinau, , Moldova
Local Institution - 0199
Arequipa, , Peru
Local Institution - 0104
Lima, , Peru
Local Institution - 0094
Râmnicu Vâlcea, Vâlcea County, Romania
Local Institution - 0143
Timișoara, , Romania
Local Institution - 0102
Gwangju, Kwangju-Kwangyǒkshi, South Korea
Local Institution - 0101
Suwon, Kyǒnggi-do, South Korea
Local Institution - 0144
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0169
Seoul, , South Korea
Local Institution - 0184
Ankara, , Turkey (Türkiye)
Local Institution - 0168
Istanbul, , Turkey (Türkiye)
Local Institution - 0189
Kocaeli, , Turkey (Türkiye)
Countries
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References
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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.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2022-500699-76
Identifier Type: OTHER
Identifier Source: secondary_id
IM011-246
Identifier Type: -
Identifier Source: org_study_id
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