A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
NCT ID: NCT07175285
Last Updated: 2026-01-22
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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RECRUITING
223 participants
OBSERVATIONAL
2025-10-08
2032-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Participants with systemic lupus erythematosus (SLE), including Lupus Nephritis, with inadequate response to glucocorticoids and at least 2 immunosuppressants, receiving current standard of care treatment options.
Current standard of care treatment options
According to the product label
Interventions
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Current standard of care treatment options
According to the product label
Eligibility Criteria
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Inclusion Criteria
* Participants must be ≥16 years of age at the time of signing the ICF
* Meet the European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2019 classification criteria for systemic lupus erythematosus (SLE)
* Have an inadequate response to glucocorticoids and ≥ 2 immunosuppressant therapies such as cyclophosphamide, mycophenolic acid and its derivatives, belimumab, anifrolumab, rituximab, methotrexate, azathioprine, obinutuzumab, cyclosporine, tacrolimus, or voclosporin, used for at least 3 months each. Eligibility is regardless of prior hydroxychloroquine or any anti-malarial treatment. Inadequate response is defined as a lack of response, insufficient response, or lack of sustained response after at least 3-month treatment with appropriate doses of a standard of care agent. Intolerance or contraindication may be considered as inadequate response provided it is documented and confirmed acceptable by the Adjudication Committee
* Have active disease at study entry when signing ICF, defined as:
* ≥ 1 British Isles Lupus Assessment Group Index (BILAG) A OR ≥ 1 BILAG B with history of SLE manifestations that would qualify for a BILAG A within the last 24 months, AND
* Positive autoantibodies (at least one) to confirm diagnosis of SLE: Antinuclear antibody ≥1:160, anti-dsDNA, anti-Sm, anti-Ro (SSA), anti-La (SSB), or low complement (C3 or C4)
* Participants with lupus nephritis meeting the study eligibility criteria must have had a renal biopsy per standard of care within the last 6 months indicating the presence of active Class III or IV lupus glomerulonephritis (alone or in combination with Class V) according to the 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS), with \< 60% interstitial fibrosis and tubular atrophy \< 60% global glomerulosclerosis
Exclusion Criteria
* Participants enrolled in concurrent interventional clinical trials involving investigational therapies or any other clinical trial
* Participant is unwilling and unable to adhere to the study visit schedule and other protocol requirements
16 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 - 0062
Mesa, Arizona, United States
Local Institution - 0054
La Jolla, California, United States
Rheumatology Center of San Diego
San Diego, California, United States
Local Institution - 0063
Fort Lauderdale, Florida, United States
Local Institution - 0061
Hollywood, Florida, United States
LIFE Clinical Trials
Margate, Florida, United States
Local Institution - 0064
Rockville, Maryland, United States
Local Institution - 0034
Ann Arbor, Michigan, United States
AA MRC
Grand Blanc, Michigan, United States
Local Institution - 0060
West Long Branch, New Jersey, United States
Local Institution - 0039
Brooklyn, New York, United States
DJL Clinical Research, PLLC
Charlotte, North Carolina, United States
Local Institution - 0037
Durham, North Carolina, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Local Institution - 0052
Philadelphia, Pennsylvania, United States
El Paso Medical Research Institute (MedResearch, Inc)
El Paso, Texas, United States
Local Institution - 0051
Van Vleck, Texas, United States
Local Institution - 0029
San Miguel de Tucumán, Tucumán Province, Argentina
Local Institution - 0050
Buenos Aires, , Argentina
Local Institution - 0042
São Paulo, , Brazil
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Local Institution - 0038
Sherbrooke, Quebec, Canada
Local Institution - 0023
Bordeaux, , France
Local Institution - 0044
Paris, , France
Local Institution - 0041
Kiel, Schleswig-Holstein, Germany
Local Institution - 0043
Mainz, , Germany
Meir Medical Center
Kfar Saba, M, Israel
Carmel Medical Center
Haifa, , Israel
Local Institution - 0040
Ferrara, RE, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, TO, Italy
Local Institution - 0049
Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0053
Sendai, Miyagi, Japan
Local Institution - 0055
Wakayama, , Japan
Local Institution - 0046
San Juan, PR, Puerto Rico
Local Institution - 0047
Mérida, Badajoz, Spain
Local Institution - 0048
Barcelona, , Spain
Local Institution - 0056
Oxford, OXF, United Kingdom
Local Institution - 0058
Bath, SOM, United Kingdom
Local Institution - 0045
Wolverhampton, West Midlands, United Kingdom
Local Institution - 0059
London, , United Kingdom
Local Institution - 0057
London, , United Kingdom
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain NCT # and Site #.
Role: CONTACT
Facility Contacts
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Site 0062
Role: primary
Site 0054
Role: primary
Tania Rivera, Site 0035
Role: primary
Site 0063
Role: primary
Site 0061
Role: primary
Jigar Shah, Site 0006
Role: primary
Site 0064
Role: primary
Site 0034
Role: primary
Ali Karrar, Site 0030
Role: primary
Site 0060
Role: primary
Site 0039
Role: primary
Charles Withers, Site 0026
Role: primary
Site 0037
Role: primary
Cristina Arriens, Site 0019
Role: primary
Site 0052
Role: primary
German Hernandez, Site 0027
Role: primary
Site 0051
Role: primary
Site 0029
Role: primary
Site 0050
Role: primary
Site 0042
Role: primary
Catherine Ivory, Site 0021
Role: primary
Site 0038
Role: primary
Site 0023
Role: primary
Site 0044
Role: primary
Site 0041
Role: primary
Site 0043
Role: primary
Shaye Kivity, Site 0012
Role: primary
Devy Zisman, Site 0036
Role: primary
Site 0040
Role: primary
Mariele Gatto, Site 0014
Role: primary
Site 0049
Role: primary
Site 0053
Role: primary
Site 0055
Role: primary
Site 0046
Role: primary
Site 0047
Role: primary
Site 0048
Role: primary
Site 0056
Role: primary
Site 0058
Role: primary
Site 0045
Role: primary
Site 0059
Role: primary
Site 0057
Role: primary
Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Other Identifiers
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CA061-1025
Identifier Type: -
Identifier Source: org_study_id
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