Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07175285

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

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

16 Years - Any

Study Type

OBSERVATIONAL

Enrollment

223

Start Date

2025-10-08

Completion Date

2032-11-01

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Systemic Lupus Erythematosus (SLE)

Interventions

DRUG

Current standard of care treatment options

According to the product label

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

Locations (52)

Local Institution - 0062

Mesa, Arizona, United States

Local Institution - 0054

La Jolla, California, United States

Local Institution - 0001

La Palma, 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 - 0068

Palm Beach Gardens, Florida, United States

Local Institution - 0065

Willowbrook, Illinois, 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

Kings County Hospital Center - Brooklyn

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

Local Institution - 0067

Murfreesboro, Tennessee, United States

Local Institution - 0066

Corpus Christi, Texas, United States

El Paso Medical Research Institute (MedResearch, Inc)

El Paso, Texas, United States

Local Institution - 0051

Van Vleck, Texas, United States

Instituto Médico CER

Quilmes, Buenos Aires, Argentina

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

Organización Médica de Investigación (OMI)

Buenos Aires, Argentina

Instituto De Reumatologia - IR Medical Center - Hospital de Dia

Mendoza, 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

Sheba Medical Center

Ramat Gan, TA, Israel

Rambam Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Rabin Medical Center - Hasharon Hospital

Petah Tikva, Israel

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

Ferrara, RE, Italy

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, TO, Italy

ASST degli Spedali Civili di Brescia

Brescia, 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

Hospital de Merida

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