A Study to Evaluate Efficacy and Safety of Deucravacitinib in Participants With Active Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE)
NCT ID: NCT04857034
Last Updated: 2025-09-10
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
74 participants
INTERVENTIONAL
2021-07-12
2028-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Continue the Administration of Deucravacitinib in Participants With Systemic Lupus Erythematosus (SLE) or Discoid and/or Subacute Cutaneous Lupus Erythematosus (DLE/SCLE) Who Have Completed Study IM011074 or Study IM011132
NCT06875960
Long-Term Safety and Efficacy Study of Deucravacitinib in Participants With Systemic Lupus Erythematosus
NCT03920267
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
NCT05620407
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
NCT05617677
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
NCT03252587
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active Treatment: Deucravacitinib Dose 1
Deucravacitinib
Specified dose on specified days
Active Treatment: Deucravacitinib Dose 2
Deucravacitinib
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Deucravacitinib
Specified dose on specified days
Placebo
Specified dose on specified days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (CLE) criteria per protocol
* Currently receiving treatment for DLE/SCLE with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant
* Participant could be with or without concurrent systemic lupus erythematosus (SLE)
* If participant receives nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening
Exclusion Criteria
* Any of the following specific CLE subtypes in isolation: acute cutaneous lupus erythematosus (ACLE), lupus tumidus, lupus (profundus) panniculitis, chilblains
* Drug-induced CLE and/or drug-induced systemic lupus erythematosus (SLE)
* Antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit
* History of 3 or more unexplained consecutive pregnancy losses
* Active severe or unstable neuropsychiatric SLE
* Other autoimmune diseases or non-SLE driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of CLE/SLE disease manifestations and activity
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 0077
Scottsdale, Arizona, United States
Local Institution - 0076
Irvine, California, United States
Local Institution - 0046
Los Angeles, California, United States
Local Institution - 0073
Farmington, Connecticut, United States
Local Institution - 0082
Orlando, Florida, United States
Local Institution - 0060
Ann Arbor, Michigan, United States
Local Institution - 0059
St Louis, Missouri, United States
Local Institution - 0037
New York, New York, United States
Local Institution - 0065
Durham, North Carolina, United States
Local Institution - 0067
Columbus, Ohio, United States
Local Institution - 0026
Oklahoma City, Oklahoma, United States
Local Institution - 0054
Charleston, South Carolina, United States
Local Institution - 0018
Capital Federal, Buenos Aires, Argentina
Local Institution - 0013
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0019
Buenos Aires, , Argentina
Local Institution - 0003
Botany, New South Wales, Australia
Local Institution - 0001
Kogarah, New South Wales, Australia
Local Institution - 0002
Camberwell, Victoria, Australia
Local Institution - 0007
Clayton, Victoria, Australia
Local Institution - 0078
Melbourne, Victoria, Australia
Local Institution - 0087
Victoria Park, Western Australia, Australia
Local Institution - 0038
Bordeaux, , France
Local Institution - 0027
Créteil, , France
Local Institution - 0010
Paris, , France
Local Institution - 0072
Dresden, Saxony, Germany
Local Institution - 0035
Berlin, , Germany
Local Institution - 0014
Erlangen, , Germany
Local Institution - 0006
Hamburg, , Germany
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution - 0058
Zapopan, Jalisco, Mexico
Local Institution - 0036
Monterrey, Nuevo León, Mexico
Local Institution - 0029
Aguascalientes, , Mexico
Local Institution - 0028
Guadalajara, , Mexico
Local Institution - 0071
Mexico City, , Mexico
Local Institution - 0005
Rzeszów, , Poland
Local Institution - 0009
Wroclaw, , Poland
Local Institution - 0008
Lodz, Łódź Voivodeship, Poland
Local Institution - 0031
Kaohsiung City, , Taiwan
Local Institution - 0023
Taichung, , Taiwan
Local Institution - 0021
Taichung, , Taiwan
Local Institution - 0022
Taipei, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-000071-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1246-1726
Identifier Type: REGISTRY
Identifier Source: secondary_id
IM011-132
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.