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

Recruiting now

Conditions studied: Systemic Lupus Erythematosus (SLE)

In brief

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

Key facts

Study ID

NCT07175285

Run by

Bristol-Myers Squibb

People needed

223

Starts

2025-10-08

Expected to finish

2032-10-05

Last updated by the study team

2026-07-21

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Instituto De Reumatologia - IR Medical Center - Hospital de Dia — Mendoza, Argentina (enrolling)
• CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin — Bordeaux, France (enrolling)
• Instituto Médico CER — Quilmes, Buenos Aires, Argentina (enrolling)
• Organización Médica de Investigación (OMI) — Buenos Aires, Argentina (enrolling)
• St. Joseph's Hospital — London, Ontario, Canada (enrolling)
• The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada (enrolling)
• LIFE Clinical Trials — Margate, Florida, United States (enrolling)
• Arizona Arthritis & Rheumatology Associates (AARA), P.C. - Mesa — Mesa, Arizona, United States (enrolling)
• Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán, Tucumán Province, Argentina (enrolling)
• Willow Rheumatology & Wellness — Willowbrook, Illinois, United States (enrolling)
• Centre hospitalier de l'Université Laval — Calgary, Alberta, Canada (enrolling)
• Centre for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida, United States (enrolling)
• AA MRC — Grand Blanc, Michigan, United States (enrolling)
• South Florida Rheumatology — Hollywood, Florida, United States (enrolling)
• Sahni Rheumatology & Therapy — West Long Branch, New Jersey, United States (enrolling)
• Kings County Hospital Center - Brooklyn — Brooklyn, New York, United States (enrolling)
• DJL Clinical Research, PLLC — Charlotte, North Carolina, United States (enrolling)
• One- Rheumatology — Palm Beach Gardens, Florida, United States (enrolling)
• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States (enrolling)
• Rheumatology Center of San Diego — San Diego, California, United States (enrolling)
• Murfreesboro Medical Clinic — Murfreesboro, Tennessee, United States (enrolling)
• Arthritis Care of Texas - Corpus Christi — Corpus Christi, Texas, United States (enrolling)
• El Paso Medical Research Institute (MedResearch, Inc) — El Paso, Texas, United States (enrolling)
• Arthritis & Rheumatism Associates — Rockville, Maryland, United States (enrolling)
• Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre — Strasbourg, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.