A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

May 12, 2026 updated by: Bristol-Myers Squibb

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Systemic Lupus Erythematosus

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.

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 (Estimated)

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.
268

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 2

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: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1425
        • Local Institution - 0207
      • Buenos Aires, Argentina, C1426ABP
        • Local Institution - 0128
      • San Juan, Argentina, 5400
        • Local Institution - 0041
    • Buenos Aires
      • Quilmes, Buenos Aires, Argentina, 1878
        • Local Institution - 0130
      • San Fernando, Buenos Aires, Argentina, 1646
        • Local Institution - 0195
    • Córdoba Province
      • Córdoba, Córdoba Province, Argentina, 5004
        • Local Institution - 0025
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, C1121ABE
        • Local Institution - 0074
      • CABA, Distrito Federal, Argentina, 1406
        • Local Institution - 0040
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000
        • Local Institution - 0027
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Local Institution - 0063
      • Westmead, New South Wales, Australia, 2145
        • Local Institution - 0072
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Local Institution - 0066
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Local Institution - 0065
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Local Institution - 0062
      • Ivanhoe, Victoria, Australia, 3079
        • Local Institution - 0064
  • Brazil
      • São Paulo, Brazil, 04266-010
        • Local Institution - 0009
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • Local Institution - 0006
      • Salvador, Estado de Bahia, Brazil, 41820-020
        • Local Institution - 0031
    • Mato Grosso
      • Cuiabá, Mato Grosso, Brazil, 78020-500
        • Local Institution - 0093
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • Local Institution - 0008
    • Paraná
      • Curitiba, Paraná, Brazil, 80030110
        • Local Institution - 0010
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90480-000
        • Local Institution - 0007
    • São Paulo
      • São Bernardo do Campo, São Paulo, Brazil, 09715-090
        • Local Institution - 0014
      • São José do Rio Preto, São Paulo, Brazil, 15090000
        • Local Institution - 0045
  • Chile
    • Los Lagos Region
      • Osorno, Los Lagos Region, Chile, 5290000
        • Local Institution - 0127
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 2279374
        • Local Institution - 0143
    • Santiago Metropolitan
      • Providencia, Santiago Metropolitan, Chile, 7500504
        • Local Institution - 0075
      • Santiago, Santiago Metropolitan, Chile
        • Local Institution - 0073
      • Santiago, Santiago Metropolitan, Chile, 7501126
        • Local Institution - 0043
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100029
        • Local Institution - 0177
      • Beijing, Beijing Municipality, China, 100144
        • Local Institution - 0180
    • Guangdong
      • Shenzhen, Guangdong, China, 518107
        • Local Institution - 0184
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Local Institution - 0176
      • Nanjing, Jiangsu, China, 210029
        • Local Institution - 0188
      • Suzhou, Jiangsu, China, 215006
        • Local Institution - 0193
    • Jilin
      • Changchun, Jilin, China, 130000
        • Local Institution - 0174
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Local Institution - 0179
    • Shandong
      • Jinan, Shandong, China, 250012
        • Local Institution - 0178
      • Jining, Shandong, China, 272011
        • Local Institution - 0183
  • Colombia
      • Barranquilla, Colombia, 080020
        • Local Institution - 0001
      • Bogotá, Colombia, 110221
        • Local Institution - 0004
      • Cali, Colombia, 760042
        • Local Institution - 0076
      • Chía, Colombia, 250001
        • Local Institution - 0005
      • Zipaquirá, Colombia, 250252
        • Local Institution - 0003
    • Antioquia
      • Medellín, Antioquia, Colombia, 050021
        • Local Institution - 0190
  • France
      • Bordeaux, France, 33076
        • Local Institution - 0048
      • Caen, France, 14033
        • Local Institution - 0144
      • Lille, France, 59037
        • Local Institution - 0129
      • Marseille, France, 13003
        • Local Institution - 0112
      • Strasbourg, France, 67098
        • Local Institution - 0044
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Local Institution - 0156
    • Finistère
      • Brest, Finistère, France, 29609
        • Local Institution - 0083
  • Germany
      • Berlin, Germany, 10117
        • Local Institution - 0085
      • Essen, Germany, 45122
        • Local Institution - 0086
      • Freiburg im Breisgau, Germany, 79106
        • Local Institution - 0084
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Local Institution - 0087
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Local Institution - 0226
    • Haryana
      • Gurugram, Haryana, India, 122001
        • Local Institution - 0214
    • Karnataka
      • Bengaluru, Karnataka, India, 560010
        • Local Institution - 0210
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Local Institution - 0208
    • Telangana
      • Secunderabad, Telangana, India, 500003
        • Local Institution - 0209
  • Ireland
      • Dublin, Ireland, D15 X40D
        • Local Institution - 0106
      • Galway, Ireland, H91 TY80
        • Local Institution - 0107
    • Leitrim
      • Manorhamilton, Leitrim, Ireland
        • Local Institution - 0119
  • Japan
      • Aichi, Japan, 457-8511
        • Local Institution - 0138
      • Chiba, Japan, 260-8712
        • Local Institution - 0115
      • Fukushima, Japan, 960-1295
        • Local Institution - 0162
      • Tokyo, Japan, 104-8560
        • Local Institution - 0097
      • Tokyo, Japan, 113-8654
        • Local Institution - 0116
    • Fukui
      • Eiheiji-cho,Yoshida-gun, Fukui, Japan, 910-1193
        • Local Institution - 0114
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Local Institution - 0095
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Local Institution - 0096
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8641
        • Local Institution - 0104
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
        • Local Institution - 0099
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138431
        • Local Institution - 0117
      • Fuchū, Tokyo, Japan, 1838524
        • Local Institution - 0218
      • Itabashiku, Tokyo, Japan, 173-8610
        • Local Institution - 0113
      • Meguro-ku, Tokyo, Japan, 1538515
        • Local Institution - 0150
      • Shinjuku-ku, Tokyo, Japan, 1600035
        • Local Institution - 0098
      • Shinjuku-ku, Tokyo, Japan, 1628655
        • Local Institution - 0105
  • Mexico
      • Chihuahua City, Mexico, 31210
        • Local Institution - 0021
      • Mexico City, Mexico, 14080
        • Local Institution - 0158
      • Mérida, Mexico, 97070
        • Local Institution - 0061
    • Guanajuato
      • León, Guanajuato, Mexico, 37000
        • Local Institution - 0020
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44650
        • Local Institution - 0017
      • Zapopan, Jalisco, Mexico, 45070
        • Local Institution - 0022
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06760
        • Local Institution - 0060
      • Mexico City, Mexico City, Mexico, 11850
        • Local Institution - 0018
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Local Institution - 0071
  • Poland
      • Poznan, Poland, 60-218
        • Local Institution - 0049
      • Warsaw, Poland, 00-874
        • Local Institution - 0149
      • Wroclaw, Poland, 50-556
        • Local Institution - 0052
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-665
        • Local Institution - 0204
  • Puerto Rico
      • San Juan, Puerto Rico, 00917
        • Local Institution - 0037
  • Romania
      • Bucharest, Romania, 011053
        • Local Institution - 0157
      • Bucharest, Romania, 011172
        • Local Institution - 0067
      • Giroc, Romania, 307220
        • Local Institution - 0068
    • Vâlcea County
      • Râmnicu Vâlcea, Vâlcea County, Romania, 247065
        • Local Institution - 0082
  • Spain
      • A Coruña, Spain, 15006
        • Local Institution - 0056
      • Barcelona, Spain, 08035
        • Local Institution - 0058
      • Madrid, Spain, 28009
        • Local Institution - 0055
      • Seville, Spain, 41014
        • Local Institution - 0057
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Local Institution - 0206
  • Taiwan
      • Kaohsiung Niao Sung Dist, Taiwan, 83301
        • Local Institution - 0080
      • Taichung, Taiwan, 404
        • Local Institution - 0081
      • Taichung, Taiwan, 407
        • Local Institution - 0078
      • Taipei, Taiwan, 10002
        • Local Institution - 0079
      • Taipei, Taiwan, 11217
        • Local Institution - 0077
  • United Kingdom
      • Bradford, United Kingdom, BD5 0NA
        • Local Institution - 0110
      • Manchester, United Kingdom, M13 9WL
        • Local Institution - 0125
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Local Institution - 0111
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Local Institution - 0100
    • California
      • Huntington Beach, California, United States, 92648
        • Local Institution - 0123
      • La Jolla, California, United States, 92037
        • Local Institution - 0170
      • La Palma, California, United States, 90623
        • Local Institution - 0159
      • San Diego, California, United States, 92128
        • Local Institution - 0172
      • Woodland Hills, California, United States, 91364
        • Local Institution - 0164
    • Florida
      • Clearwater, Florida, United States, 33765
        • Local Institution - 0121
      • Kissimmee, Florida, United States, 34741
        • Local Institution - 0167
      • Orlando, Florida, United States, 32808
        • Local Institution - 0122
      • Ormond Beach, Florida, United States, 32174
        • Local Institution - 0173
      • Plantation, Florida, United States, 33324
        • Local Institution - 0154
      • South Miami, Florida, United States, 33143
        • Local Institution - 0137
      • Tamarac, Florida, United States, 33321
        • Local Institution - 0155
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Local Institution - 0160
      • Suwanee, Georgia, United States, 30024
        • Local Institution - 0205
    • Illinois
      • Orland Park, Illinois, United States, 60467
        • Local Institution - 0146
    • Kentucky
      • Hopkinsville, Kentucky, United States, 42240
        • Local Institution - 0187
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70836
        • Local Institution - 0171
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • Local Institution - 0134
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • Local Institution - 0070
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Local Institution - 0124
      • St Louis, Missouri, United States, 63141
        • Local Institution - 0165
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Local Institution - 0091
    • New Jersey
      • West Long Branch, New Jersey, United States, 07764
        • Local Institution - 0219
    • New York
      • Manhasset, New York, United States, 11030
        • Local Institution - 0140
      • The Bronx, New York, United States, 10461
        • Local Institution - 0132
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0203
      • Charlotte, North Carolina, United States, 28211
        • Local Institution - 0103
    • Ohio
      • Columbus, Ohio, United States, 43203
        • Local Institution - 0151
      • Middleburg Heights, Ohio, United States, 44130
        • Local Institution - 0042
    • Texas
      • Allen, Texas, United States, 75013
        • Local Institution - 0152
      • Allen, Texas, United States, 75013
        • Local Institution - 0197
      • Amarillo, Texas, United States, 79124
        • Local Institution - 0136
      • Mesquite, Texas, United States, 75150
        • Local Institution - 0029
      • San Antonio, Texas, United States, 78215
        • Local Institution - 0163
    • Washington
      • Bellevue, Washington, United States, 98004
        • Local Institution - 0223

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit
  • Test positive, as determined by the central laboratory, for at least one of the following lupus related autoantibodies at the time of screening: antinuclear antibody ≥ 1:80, anti-double-stranded deoxyribonucleic acid (dsDNA) antibody, or anti-Smith antibody.
  • Have a total Hybrid Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score ≥ 6 points and clinical Hybrid SLEDAI score ≥ 4 points with joint involvement and/or rash

Exclusion Criteria:

  • Active severe lupus nephritis (LN) as assessed by the investigator
  • Active or unstable neuropsychiatric lupus manifestations defined by the Hybrid SLEDAI
  • Diagnosis of Mixed Connective Tissue Disease for which the predominant diagnosis is not SLE
  • Antiphospholipid Syndrome

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: Quadruple

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.
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days
Experimental: Afimetoran: Dose 1
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256
Experimental: Afimetoran: Dose 2
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256
Experimental: Afimetoran: Dose 3
Drug: Afimetoran
Specified dose on specified days
Other Names:
  • BMS-986256

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 that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks

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
Measure Description
Time Frame
Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index; Activity (CLASI-A) score ≥ 10 at baseline who achieve a decrease of ≥ 50% from baseline CLASI-A score (CLASI-50) response at Week 24 and Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Proportion of participants with 6 or more swollen joints and 6 or more tender joints at baseline who achieve a ≥ 50% reduction from baseline in both swollen and tender joints at Week 24 and Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Mean change from baseline in swollen joint count using the 28-joint count at Week 24 and Week 48 in participants with ≥ 2 swollen joints at baseline
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Mean change from baseline in tender joint count at Week 24 and Week 48 using the 28- joint count in participants with ≥ 2 tender joints at baseline
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Change from baseline in PGA score of disease activity at Week 24 and Week 48
Time Frame: Up to 48 Weeks
PGA = Physician Global Assessment of disease activity (score of "0" indicating no disease activity and higher scores indicating higher disease activity)
Up to 48 Weeks
Proportion of participants who achieve CS reduction or maintenance to ≤ 7.5 mg per day at Week 48
Time Frame: Up to 48 Weeks
Up to 48 Weeks
Change in participant reported disease activity from baseline to Week 24 and Week 48 according to the 36-item Short Form Health Questionnaire (SF-36)
Time Frame: Up to 48 Weeks
The SF-36 was designed as an indicator of health status in population surveys, and health policy evaluations, and for use as an outcome measure in clinical practice and research. Scores for each domain range from 0 to 100, with high scores indicating a better health status.
Up to 48 Weeks
Number of participants with Adverse Events (AEs)
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with Serious Adverse Events (SAEs)
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with physical examination abnormalities
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with vital sign abnormalities
Time Frame: Up to 100 Weeks
Up to 100 Weeks
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 52 Weeks
Up to 52 Weeks
Proportion of participants who achieve an SRI(4) response at Week 24
Time Frame: Up to 24 Weeks
Up to 24 Weeks

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.

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.
October 11, 2021

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.
June 18, 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.
April 22, 2029

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).
May 19, 2021

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.
May 19, 2021

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.
May 20, 2021

Study Record Updates

Last Update Posted (Actual)

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.
May 14, 2026

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.
May 12, 2026

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.
May 1, 2026

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.
  • IM026-024
  • U1111-1241-6528 (Registry Identifier: UTN)
  • 2023-504320-25-00 (Registry Identifier: EU Trial 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.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

product manufactured in and exported from the U.S.

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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