Recruiting

Standard of Care

Sponsor:

Bristol-Myers Squibb

Code:

NCT07175285

Conditions

Systemic Lupus Erythematosus (SLE)

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

Interventions

Current standard of care treatment options

Study Details

Brief summary:

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

Conditions

Systemic Lupus Erythematosus (SLE)

Study ID

NCT07175285

Start date

Oct 8, 2025

Status verified date

Sep, 2026

Completion date

Oct 5, 2032

Anticipated

Primary completion date

Mar 24, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16+

Healthy Volunteers: Not accepted

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

223 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Current standard of care treatment options

According to the product label

Primary outcome measure

  • Number of of participants achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) at 6 months along with the 95% CI. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Rheumatology Center of San Diego

Recruiting

San Diego, California, United States, 92128-2551

Contacts

Tania Rivera, Site 0035

858-336-2810

Centre for Rheumatology, Immunology and Arthritis

Recruiting

Fort Lauderdale, Florida, United States, 33309-1715

Contacts

Yvonne Sherrer, Site 0063

954-229-0425

South Florida Rheumatology

Recruiting

Hollywood, Florida, United States, 33021-6052

Contacts

Gizem Gokalp, Site 0061

954-961-3252

LIFE Clinical Trials

Recruiting

Margate, Florida, United States, 33063

Contacts

Jigar Shah, Site 0006

786-674-8868

One- Rheumatology

Recruiting

Palm Beach Gardens, Florida, United States, 33410

Contacts

Clifford Stermer, Site 0068

561-559-1110

Willow Rheumatology & Wellness

Recruiting

Willowbrook, Illinois, United States, 60527

Contacts

Angela Crowley, Site 0065

972-432-6708

Arthritis & Rheumatism Associates

Recruiting

Rockville, Maryland, United States, 20850

Contacts

Evan Siegel, Site 0064

301-942-6610

AA MRC

Recruiting

Grand Blanc, Michigan, United States, 48439-2451

Contacts

Ali Karrar, Site 0030

810-667-0067

Sahni Rheumatology & Therapy

Recruiting

West Long Branch, New Jersey, United States, 07764

Contacts

KIREN SAHNI, Site 0060

732-272-1456

Kings County Hospital Center - Brooklyn

Recruiting

Brooklyn, New York, United States, 11203

Contacts

Alexander Feoktistov, Site 0039

520-834-8259

DJL Clinical Research, PLLC

Recruiting

Charlotte, North Carolina, United States, 28211

Contacts

Charles Withers, Site 0026

704-247-9179

Oklahoma Medical Research Foundation

Recruiting

Oklahoma City, Oklahoma, United States, 73104-5005

Contacts

Cristina Arriens, Site 0019

405-271-7805

Murfreesboro Medical Clinic

Recruiting

Murfreesboro, Tennessee, United States, 37128

Arthritis Care of Texas - Corpus Christi

Recruiting

Corpus Christi, Texas, United States, 78415

Contacts

Eric Chiang, Site 0066

361-400-7700

Lone Star Arthritis & Rheumatology Associates, P.C.

Recruiting

Denton, Texas, United States, 76205

Contacts

Michelle Luciano, Site 0062

480-400-8502

El Paso Medical Research Institute (MedResearch, Inc)

Recruiting

El Paso, Texas, United States, 79902-4821

Contacts

German Hernandez, Site 0027

915-544-4572

Centre hospitalier de l'Université Laval

Recruiting

Calgary, Alberta, Canada, T2T 5C7

Contacts

Paul Fortin, Site 0018

4166035753

St. Joseph's Hospital

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Janet Pope, Site 0020

519 646 6332

The Ottawa Hospital - General Campus

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Systemic lupus erythematosus (SLE)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-09-03.