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Clinical Trials in the UK / NCT07175285
Recruiting Observational

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

NCT07175285 · tracked via the Priya Life Science UK tracker
Sponsor
Bristol-Myers Squibb
Phase
Observational
Started
2025-10-08
Last updated
2026-09-03

Condition(s) studied

Systemic Lupus Erythematosus (SLE)

Investigational drug(s) / intervention(s)

Current standard of care treatment options

Current standard of care treatment options: According to the product label

Study 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

Sex
ALL
Min age
16 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (66)

FacilityCityRegionStatus
Local Institution - 0054 La Jolla California Not Yet Recruiting
Local Institution - 0001 La Palma California Not Yet Recruiting
Local Institution - 0071 Los Angeles California Not Yet Recruiting
Rheumatology Center of San Diego San Diego California Recruiting
Centre for Rheumatology, Immunology and Arthritis Fort Lauderdale Florida Recruiting
South Florida Rheumatology Hollywood Florida Recruiting
LIFE Clinical Trials Margate Florida Recruiting
One- Rheumatology Palm Beach Gardens Florida Recruiting
Local Institution - 0069 Atlanta Georgia Not Yet Recruiting
Willow Rheumatology & Wellness Willowbrook Illinois Recruiting
Arthritis & Rheumatism Associates Rockville Maryland Recruiting
Local Institution - 0034 Ann Arbor Michigan Not Yet Recruiting
AA MRC Grand Blanc Michigan Recruiting
Local Institution - 0070 Kalispell Montana Not Yet Recruiting
Sahni Rheumatology & Therapy West Long Branch New Jersey Recruiting
Kings County Hospital Center - Brooklyn Brooklyn New York Recruiting
DJL Clinical Research, PLLC Charlotte North Carolina Recruiting
Local Institution - 0037 Durham North Carolina Withdrawn
Oklahoma Medical Research Foundation Oklahoma City Oklahoma Recruiting
Local Institution - 0075 Philadelphia Pennsylvania Not Yet Recruiting
Local Institution - 0052 Philadelphia Pennsylvania Not Yet Recruiting
Murfreesboro Medical Clinic Murfreesboro Tennessee Recruiting
Arthritis Care of Texas - Corpus Christi Corpus Christi Texas Recruiting
Lone Star Arthritis & Rheumatology Associates, P.C. Denton Texas Recruiting
El Paso Medical Research Institute (MedResearch, Inc) El Paso Texas Recruiting
Local Institution - 0051 Van Vleck Texas Not Yet Recruiting
Instituto Médico CER Quilmes Buenos Aires Recruiting
Centro de Investigaciones Medicas Tucuman San Miguel de Tucumán Tucumán Province Recruiting
Organización Médica de Investigación (OMI) Buenos Aires Argentina Recruiting
Instituto De Reumatologia - IR Medical Center - Hospital de Dia Mendoza Argentina Recruiting
Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
Local Institution - 0007 Porto Alegre Rio Grande do Sul Not Yet Recruiting
Local Institution - 0042 São Paulo Brazil Not Yet Recruiting
Centre hospitalier de l'Université Laval Calgary Alberta Recruiting
St. Joseph's Hospital London Ontario Recruiting
The Ottawa Hospital - General Campus Ottawa Ontario Recruiting
Local Institution - 0038 Sherbrooke Quebec Not Yet Recruiting
CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin Bordeaux France Recruiting
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre Strasbourg France Recruiting
Hôpital Saint-Antoine Paris Île-de-France Region Recruiting

+ 26 more sites — see the full list on the official registry below.

More Bristol-Myers Squibb trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07175285 on ClinicalTrials.gov ↗ ← All trials in the UK