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

November 26, 2025 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
516

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
Time Frame: At week 52
At week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
Time Frame: At week 52
At week 52
Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
Time Frame: At week 52
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
Time Frame: At week 52
At week 52
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
Time Frame: At week 52
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
Time Frame: At week 52
At week 52
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Time Frame: At week 52
At week 52
Number of participants with adverse events (AEs)
Time Frame: Up to 156 weeks
Up to 156 weeks
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 156 weeks
Up to 156 weeks
Number of participants with AEs leading to discontinuation of treatment
Time Frame: Up to 156 weeks
Up to 156 weeks
Number of participants with AEs leading to study discontinuation
Time Frame: Up to 156 weeks
Up to 156 weeks
Number of participants with laboratory abnormalities
Time Frame: Up to 156 weeks
Up to 156 weeks
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 156 weeks
Up to 156 weeks
Number of participants with vital sign abnormalities
Time Frame: Up to 156 weeks
Up to 156 weeks
Number of participants with target adverse events of special interest (AESIs)
Time Frame: Up to 156 weeks
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.
Time Frame: At Week 52
At Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 19, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 13, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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