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A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants

NCT07175285 · Bristol-Myers Squibb
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Official title
Prospective, Observational Study in Participants With Active Systemic Lupus Erythematosus (SLE) (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and At Least 2 Immunosuppressants
About this study
The purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response to glucocorticoids and at least two immunosuppressants
Eligibility criteria
Inclusion Criteria: * Participants must have signed and dated an Institutional Review Board/ Independent Ethics Committee (IRB/IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines * 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, one of which is a biologic therapy consistent with treatment guidelines, 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 proteins (C3 or C4) * Participants with lupus nephritis (LN) meeting the study eligibility criteria must have had a renal biopsy per standard of care within 6 months (± 30 days) prior to signing the ICF, indicating the presence of active Class III or IV LN (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: * Pregnant women * Participants enrolled in concurrent interventional clinical trials involving investigational therapies or any other clinical trial * Participant is unwilling or unable to comply with routine clinical follow-up necessary for collection of study data
Study design
Enrollment target: 223 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2025-10-08
Estimated completion: 2032-11-01
Last updated: 2026-04-13
Interventions
Drug: Current standard of care treatment options
Primary outcomes
  • Number of of participants achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) at 6 months along with the 95% CI. (6 months)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol Myers Squibb · study_director, Bristol-Myers Squibb
All locations (53)
Local Institution - 0062Not Yet Recruiting
Mesa, Arizona, United States
Local Institution - 0054Not Yet Recruiting
La Jolla, California, United States
Local Institution - 0001Not Yet Recruiting
La Palma, California, United States
Rheumatology Center of San DiegoRecruiting
San Diego, California, United States
Local Institution - 0063Not Yet Recruiting
Fort Lauderdale, Florida, United States
Local Institution - 0061Not Yet Recruiting
Hollywood, Florida, United States
LIFE Clinical TrialsRecruiting
Margate, Florida, United States
Local Institution - 0068Not Yet Recruiting
Palm Beach Gardens, Florida, United States
Local Institution - 0069Not Yet Recruiting
Atlanta, Georgia, United States
Local Institution - 0065Not Yet Recruiting
Willowbrook, Illinois, United States
Local Institution - 0064Not Yet Recruiting
Rockville, Maryland, United States
Local Institution - 0034Not Yet Recruiting
Ann Arbor, Michigan, United States
AA MRCRecruiting
Grand Blanc, Michigan, United States
Sahni Rheumatology & TherapyRecruiting
West Long Branch, New Jersey, United States
Kings County Hospital Center - BrooklynRecruiting
Brooklyn, New York, United States
DJL Clinical Research, PLLCRecruiting
Charlotte, North Carolina, United States
Local Institution - 0037Not Yet Recruiting
Durham, North Carolina, United States
Oklahoma Medical Research FoundationRecruiting
Oklahoma City, Oklahoma, United States
Local Institution - 0052Not Yet Recruiting
Philadelphia, Pennsylvania, United States
Local Institution - 0067Not Yet Recruiting
Murfreesboro, Tennessee, United States
Local Institution - 0066Not Yet Recruiting
Corpus Christi, Texas, United States
El Paso Medical Research Institute (MedResearch, Inc)Recruiting
El Paso, Texas, United States
Local Institution - 0051Not Yet Recruiting
Van Vleck, Texas, United States
Instituto Médico CERRecruiting
Quilmes, Buenos Aires, Argentina
Centro de Investigaciones Medicas TucumanRecruiting
San Miguel de Tucumán, Tucumán Province, Argentina
Organización Médica de Investigación (OMI)Recruiting
Buenos Aires, Argentina
Instituto De Reumatologia - IR Medical Center - Hospital de DiaRecruiting
Mendoza, Argentina
Local Institution - 0042Not Yet Recruiting
São Paulo, Brazil
The Ottawa Hospital - General CampusRecruiting
Ottawa, Ontario, Canada
Local Institution - 0038Not Yet Recruiting
Sherbrooke, Quebec, Canada
Local Institution - 0023Not Yet Recruiting
Bordeaux, France
Local Institution - 0044Not Yet Recruiting
Paris, France
Local Institution - 0041Not Yet Recruiting
Kiel, Schleswig-Holstein, Germany
Local Institution - 0043Not Yet Recruiting
Mainz, Germany
Meir Medical CenterRecruiting
Kfar Saba, M, Israel
Sheba Medical CenterRecruiting
Ramat Gan, TA, Israel
Rambam Medical CenterRecruiting
Haifa, Israel
Carmel Medical CenterRecruiting
Haifa, Israel
Rabin Medical Center - Hasharon HospitalRecruiting
Petah Tikva, Israel
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'AnnaRecruiting
Ferrara, RE, Italy
Azienda Ospedaliera Ordine Mauriziano di TorinoRecruiting
Torino, TO, Italy
ASST degli Spedali Civili di BresciaRecruiting
Brescia, Italy
Local Institution - 0049Not Yet Recruiting
Kitakyushu-shi, Fukuoka, Japan
Local Institution - 0053Not Yet Recruiting
Sendai, Miyagi, Japan
Local Institution - 0055Not Yet Recruiting
Wakayama, Japan
Local Institution - 0046Not Yet Recruiting
San Juan, PR, Puerto Rico
Hospital de MeridaRecruiting
Mérida, Badajoz, Spain
Local Institution - 0048Not Yet Recruiting
Barcelona, Spain
Local Institution - 0056Not Yet Recruiting
Oxford, OXF, United Kingdom
Local Institution - 0058Not Yet Recruiting
Bath, SOM, United Kingdom
Local Institution - 0045Not Yet Recruiting
Wolverhampton, West Midlands, United Kingdom
Local Institution - 0059Not Yet Recruiting
London, United Kingdom
Local Institution - 0057Not Yet Recruiting
London, United Kingdom
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants · TrialPath