A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
NCT ID: NCT05620407
Last Updated: 2025-12-02
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
513 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
QUADRUPLE
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.
* In Japan only: Participants with positive result of β - D-glucan assay.
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 - 0063
La Jolla, California, United States
Local Institution - 0241
La Mesa, California, United States
Local Institution - 0242
San Diego, California, United States
Local Institution - 0143
San Leandro, California, United States
Local Institution - 0147
Santa Monica, California, United States
Local Institution - 0213
Clearwater, Florida, United States
Local Institution - 0059
Jacksonville, Florida, United States
Local Institution - 0075
Margate, Florida, United States
Local Institution - 0007
Oakland Park, Florida, United States
Local Institution - 0239
Plant City, Florida, United States
Emory University School of Medicine- Grady Campus
Atlanta, Georgia, United States
Local Institution - 0137
Marietta, Georgia, United States
Local Institution - 0089
Orland Park, Illinois, United States
Local Institution - 0041
Skokie, Illinois, United States
Local Institution - 0231
New Orleans, Louisiana, United States
Local Institution - 0060
Boston, Massachusetts, United States
Local Institution - 0056
Boston, Massachusetts, United States
Local Institution - 0084
Worcester, Massachusetts, United States
Local Institution - 0152
Grand Blanc, Michigan, United States
Local Institution - 0072
Rochester, Minnesota, United States
Local Institution - 0216
Las Vegas, Nevada, United States
Local Institution - 0165
Paramus, New Jersey, United States
Local Institution - 0069
Brooklyn, New York, United States
Local Institution - 0217
Great Neck, New York, United States
Local Institution - 0150
New York, New York, United States
Local Institution - 0102
New York, New York, United States
Local Institution - 0145
Syracuse, New York, United States
Local Institution - 0178
Charlotte, North Carolina, United States
Local Institution - 0005
Cleveland, Ohio, United States
Local Institution - 0043
Oklahoma City, Oklahoma, United States
Local Institution - 0205
Pittsburgh, Pennsylvania, United States
Local Institution - 0081
Charleston, South Carolina, United States
Local Institution - 0225
Florence, South Carolina, United States
Local Institution - 0002
Jackson, Tennessee, United States
Local Institution - 0001
Colleyville, Texas, United States
Local Institution - 0164
El Paso, Texas, United States
Local Institution - 0169
Katy, Texas, United States
Local Institution - 0201
Temple, Texas, United States
Local Institution - 0133
Danville, Virginia, United States
Local Institution - 0146
Ciudad de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0088
La Plata, Buenos Aires, Argentina
Local Institution - 0078
Pergamino, Buenos Aires, Argentina
Local Institution - 0125
Pilar, Buenos Aires, Argentina
Local Institution - 0020
San Juan Bautista, Buenos Aires, Argentina
Local Institution - 0136
San Miguel, Buenos Aires, Argentina
Local Institution - 0018
Quilmes, Buenos Aires F.D., Argentina
Local Institution - 0013
SAN M. de Tucuman, Tucumán Province, Argentina
Local Institution - 0027
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0179
Liverpool, New South Wales, Australia
Local Institution - 0182
Paramatta, New South Wales, Australia
Local Institution - 0066
Maroochydore, Queensland, Australia
Local Institution - 0177
Ivanhoe, Victoria, Australia
Local Institution - 0129
Victoria Park, Western Australia, Australia
Local Institution - 0160
Vitória, Espírito Santo, Brazil
Local Institution - 0028
Lajeado, Rio Grande do Sul, Brazil
Local Institution - 0154
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0023
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0230
Porto Velho, Rondônia, Brazil
Local Institution - 0175
Barretos, São Paulo, Brazil
Local Institution - 0115
São Bernardo do Campo, São Paulo, Brazil
Local Institution - 0087
Rio de Janeiro, , Brazil
Local Institution - 0161
São Paulo, , Brazil
Local Institution - 0062
São Paulo, , Brazil
Local Institution - 0190
São Paulo, , Brazil
Local Institution - 0163
Sofia, Sofia (stolitsa), Bulgaria
Local Institution - 0158
Plovdiv, , Bulgaria
Local Institution - 0159
Rousse, , Bulgaria
Local Institution - 0139
La Serena, Coquimbo Region, Chile
Local Institution - 0220
Santiago, Santiago Metropolitan, Chile
Local Institution - 0101
Santiago, Santiago Metropolitan, Chile
Local Institution - 0183
Santiago, Santiago Metropolitan, Chile
Local Institution - 0140
Santiago, Santiago Metropolitan, Chile
Local Institution - 0203
Santiago, Santiago Metropolitan, Chile
Local Institution - 0153
Santiago, , Chile
Local Institution - 0174
Ostrava, Ostrava Město, Czechia
Local Institution - 0036
Prague, , Czechia
Local Institution - 0123
Athens, Attikí (Region), Greece
Local Institution - 0116
Athens, Attikí, Greece
Local Institution - 0138
Larissa, Thessalía, Greece
Local Institution - 0057
Pécs, Baranya, Hungary
Local Institution - 0035
Gyula, Bekes County, Hungary
Local Institution - 0134
Szeged, Csongrád megye, Hungary
Local Institution - 0034
Veszprém, Veszprém City, Hungary
Local Institution - 0234
Ahmedabad, Gujarat, India
Local Institution - 0233
Ahmedabad, Gujarat, India
Local Institution - 0191
Hubli, Karnataka, India
Local Institution - 0222
Mysore, Karnataka, India
Local Institution - 0229
Nagpur, Maharashtra, India
Local Institution - 0210
Vellore, Tamil Nadu, India
Local Institution - 0235
Hyderabad, Telangana, India
Local Institution - 0199
Secundarabad, Telangana, India
Local Institution - 0053
Nagoya, Aichi-ken, Japan
Local Institution - 0156
Nagoya, Aichi-ken, Japan
Local Institution - 0083
Toyoake, Aichi-ken, Japan
Local Institution - 0047
Chiba, Chiba, Japan
Local Institution - 0086
Eiheiji-cho,Yoshida-gun, Fukui, Japan
Local Institution - 0117
Kitakyushu, Fukuoka, Japan
Local Institution - 0082
Asahikawa, Hokkaido, Japan
Local Institution - 0048
Sapporo, Hokkaido, Japan
Local Institution - 0162
Kita, Kagawa-ken, Japan
Local Institution - 0111
Sagamihara, Kanagawa, Japan
Local Institution - 0157
Yokohama, Kanagawa, Japan
Local Institution - 0021
Sendai, Miyagi, Japan
Local Institution - 0113
Sasebo, Nagasaki, Japan
Local Institution - 0022
Kawagoe, Saitama, Japan
Local Institution - 0171
Shimotsuga, Tochigi, Japan
Local Institution - 0173
Bunkyo-ku, Tokyo, Japan
Local Institution - 0046
Bunkyo-ku, Tokyo, Japan
Local Institution - 0045
Meguro-ku, Tokyo, Japan
Local Institution - 0064
Shinjyuku-ku, Tokyo, Japan
Local Institution - 0226
Toyoma, Toyama, Japan
Local Institution - 0227
Fukuoka, , Japan
Local Institution - 0050
Fukushima, , Japan
Local Institution - 0167
Gifu, , Japan
Local Institution - 0126
Nagasaki, , Japan
Local Institution - 0131
Niigata, , Japan
Local Institution - 0085
Okayama, , Japan
Local Institution - 0108
Osaka, , Japan
Local Institution - 0054
Tokyo, , Japan
Local Institution - 0051
Tokyo, , Japan
Local Institution - 0148
Wakayama, , Japan
Local Institution - 0107
Torreón, Coahuila, Mexico
Local Institution - 0009
León, Guanajuato, Mexico
Local Institution - 0077
Guadajalara, Jalisco, Mexico
Local Institution - 0026
Zapopan, Jalisco, Mexico
Local Institution - 0024
Mexico City, Mexico City, Mexico
Local Institution - 0011
Mexico City, Mexico City, Mexico
Local Institution - 0010
Cuernavaca, Morelos, Mexico
Local Institution - 0124
Monterrey, Nuevo León, Mexico
Local Institution - 0106
Chihuahua City, , Mexico
Local Institution - 0074
Oaxaca City, , Mexico
Local Institution - 0208
Lima, , Peru
Local Institution - 0176
Lima, , Peru
Local Institution - 0118
Lima, , Peru
Local Institution - 0121
Lima, , Peru
Local Institution - 0017
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0029
Krakow, Lesser Poland Voivodeship, Poland
Local Institution - 0186
Lublin, Lublin Voivodeship, Poland
Local Institution - 0219
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0185
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0119
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0224
Chorzów, Silesian Voivodeship, Poland
Local Institution - 0016
Elblag, Warmian-Masurian Voivodeship, Poland
Local Institution - 0071
Szczecin, , Poland
Local Institution - 0014
Warsaw, , Poland
Local Institution - 0031
Wroclaw, , Poland
Local Institution - 0187
Lodz, Łódź Voivodeship, Poland
Local Institution - 0105
Lisbon, Lisbon District, Portugal
Local Institution - 0109
Vila Nova de Gaia, Porto District, Portugal
Local Institution - 0144
Lisbon, , Portugal
Local Institution - 0073
Lisbon, , Portugal
Local Institution - 0240
Caguas, , Puerto Rico
Local Institution - 0194
San Juan, , Puerto Rico
Local Institution - 0135
Singapore, , Singapore
Local Institution - 0127
Singapore, , Singapore
Local Institution - 0151
Mérida, Badajoz, Spain
Local Institution - 0038
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0110
Bilbao, Basque Country, Spain
Local Institution - 0061
Santander, Cantabria, Spain
Local Institution - 0103
Cordoba, Madrid, Spain
Local Institution - 0052
Seville, , Spain
Local Institution - 0058
Valencia, , Spain
Local Institution - 0067
Valladolid, , Spain
Local Institution - 0094
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Local Institution - 0040
Taichung, Taichung, Taiwan
Local Institution - 0065
Taichung, , Taiwan
Local Institution - 0114
Taichung, , Taiwan
Local Institution - 0039
Tainan, , Taiwan
Local Institution - 0181
Taipei, , Taiwan
Local Institution - 0122
Taipei, , Taiwan
Local Institution - 0212
Bangkok, Bangkok, Thailand
Local Institution - 0211
Bangkok, Bangkok, Thailand
Local Institution - 0184
Ankara, , Turkey (Türkiye)
Local Institution - 0166
Antalya, , Turkey (Türkiye)
Local Institution - 0188
Gaziantep, , Turkey (Türkiye)
Local Institution - 0223
London, England, United Kingdom
Local Institution - 0090
London, Greater London, United Kingdom
Local Institution - 0091
London, London, City of, United Kingdom
Local Institution - 0168
Central Middlesbrough, Middlesbrough, United Kingdom
Local Institution - 0130
Oxford, , United Kingdom
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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2022-500700-22
Identifier Type: OTHER
Identifier Source: secondary_id
IM011-247
Identifier Type: -
Identifier Source: org_study_id
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