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NCT07175285Recruiting

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

Bristol-Myers Squibb

Start Date

10/8/2025

Completion Date

10/5/2032

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

Eligibility Criteria

Age Range: 16 years to No maximum

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

Interventions

DRUG

Current standard of care treatment options

Interested in This Trial?

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Conditions

Systemic Lupus Erythematosus (SLE)

Locations

Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa

Mesa, Arizona 85210

United States

Local Institution - 0054

La Jolla, California 92093

United States

Local Institution - 0001

La Palma, California 90623-1730

United States

Local Institution - 0071

Los Angeles, California 90095

United States

Rheumatology Center of San Diego

San Diego, California 92128-2551

United States

Centre for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida 33309-1715

United States

South Florida Rheumatology

Hollywood, Florida 33021-6052

United States

LIFE Clinical Trials

Margate, Florida 33063

United States

One- Rheumatology

Palm Beach Gardens, Florida 33410

United States

Local Institution - 0069

Atlanta, Georgia 30322-1013

United States

Willow Rheumatology & Wellness

Willowbrook, Illinois 60527

United States

Arthritis & Rheumatism Associates

Rockville, Maryland 20850

United States

Local Institution - 0034

Ann Arbor, Michigan 48109-5000

United States

AA MRC

Grand Blanc, Michigan 48439-2451

United States

Local Institution - 0070

Kalispell, Montana 59901-3129

United States

Sahni Rheumatology & Therapy

West Long Branch, New Jersey 07764

United States

Kings County Hospital Center - Brooklyn

Brooklyn, New York 11203

United States

DJL Clinical Research, PLLC

Charlotte, North Carolina 28211

United States

Local Institution - 0037

Durham, North Carolina 27710-1000

United States

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma 73104-5005

United States

Local Institution - 0052

Philadelphia, Pennsylvania 19140

United States

Murfreesboro Medical Clinic

Murfreesboro, Tennessee 37128

United States

Arthritis Care of Texas - Corpus Christi

Corpus Christi, Texas 78415

United States

El Paso Medical Research Institute (MedResearch, Inc)

El Paso, Texas 79902-4821

United States

Local Institution - 0051

Van Vleck, Texas 77482

United States

Instituto Médico CER

Quilmes, Buenos Aires B1878DVB

Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province T4000AXL

Argentina

Organización Médica de Investigación (OMI)

Buenos Aires, C1015ABO

Argentina

Instituto De Reumatologia - IR Medical Center - Hospital de Dia

Mendoza, M5500CPH

Argentina

Local Institution - 0005

Porto Alegre, Rio Grande do Sul 90035-903

Brazil

Local Institution - 0007

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Local Institution - 0042

São Paulo, 05403-000

Brazil

Centre hospitalier de l'Université Laval

Calgary, Alberta T2T 5C7

Canada

St. Joseph's Hospital

London, Ontario N6A 4V2

Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario K1H 8L6

Canada

Local Institution - 0038

Sherbrooke, Quebec J1G 2E8

Canada

CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, 33076

France

Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

Strasbourg, 67098

France

Hôpital Saint-Antoine

Paris, Île-de-France Region 75012

France

Local Institution - 0041

Kiel, Schleswig-Holstein 24105

Germany

Local Institution - 0043

Mainz, 55131

Germany

Meir Medical Center

Kfar Saba, M 4428164

Israel

Sheba Medical Center

Ramat Gan, TA 5262000

Israel

Rambam Medical Center

Haifa, 31096

Israel

Carmel Medical Center

Haifa, 34362

Israel

Rabin Medical Center - Hasharon Hospital

Petah Tikva, 4941492

Israel

Local Institution - 0025

Tel Aviv, 6423906

Israel

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

Ferrara, RE 44124

Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, TO 10128

Italy

ASST degli Spedali Civili di Brescia

Brescia, 25123

Italy

Local Institution - 0053

Sendai, Miyagi 980-8574

Japan

Toyama University

Toyama, Toyama 930-0887

Japan

Hospital of the University of Occupational and Environmental Health, Japan

Kitakyushu-Shi, 807-8556

Japan

Local Institution - 0055

Wakayama, 641-8510

Japan

Local Institution - 0046

San Juan, PR 00917-3104

Puerto Rico

Hospital de Merida

Mérida, Badajoz 6800

Spain

Hospital Clínic de Barcelona

Barcelona, 08036

Spain

Local Institution - 0072

Lund, Skåne County SE-221 85

Sweden

Local Institution - 0073

Solna, Stockholm County 171 64

Sweden

Local Institution - 0074

Örebro, 701 85

Sweden

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford, OXF OX3 7LE

United Kingdom

Royal National Hospital for Rheumatic Diseases-Bath

Bath, SOM BA1 3NG

United Kingdom

The Royal Wolverhampton NHS Trust - New Cross Hospital

Wolverhampton, West Midlands WV10 0QP

United Kingdom

The Royal Free London NHS Foundation Trust - The Royal Free Hospital

London, NW3 2QG

United Kingdom

King's College Hospital NHS Foundation Trust

London, SE5 9RS

United Kingdom