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

RecruitingObservational study

Prospective, Observational Study in Participants With Active Systemic Lupus Erythematosus (SLE) (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and At Least 2 Immunosuppressants

Who can join

Ages 16 and older · All sexes

Full eligibility criteria
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

About the study

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

What is being tested

Sponsor: Bristol-Myers Squibb · Participants: 223 · Started: Oct 8, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07175285

Locations in the U.S.

CaliforniaLocal Institution - 0054, La Jolla (Not yet recruiting)
Local Institution - 0001, La Palma (Not yet recruiting)
Local Institution - 0071, Los Angeles (Not yet recruiting)
Rheumatology Center of San Diego, San Diego
FloridaCentre for Rheumatology, Immunology and Arthritis, Fort Lauderdale
South Florida Rheumatology, Hollywood
LIFE Clinical Trials, Margate
One- Rheumatology, Palm Beach Gardens
GeorgiaLocal Institution - 0069, Atlanta (Not yet recruiting)
IllinoisWillow Rheumatology & Wellness, Willowbrook
MarylandArthritis & Rheumatism Associates, Rockville
MichiganLocal Institution - 0034, Ann Arbor (Not yet recruiting)
AA MRC, Grand Blanc
MontanaLocal Institution - 0070, Kalispell (Not yet recruiting)
New JerseySahni Rheumatology & Therapy, West Long Branch
New YorkKings County Hospital Center - Brooklyn, Brooklyn
North CarolinaDJL Clinical Research, PLLC, Charlotte
OklahomaOklahoma Medical Research Foundation, Oklahoma City
PennsylvaniaLocal Institution - 0052, Philadelphia (Not yet recruiting)
Local Institution - 0075, Philadelphia (Not yet recruiting)
TennesseeMurfreesboro Medical Clinic, Murfreesboro
TexasArthritis Care of Texas - Corpus Christi, Corpus Christi
Lone Star Arthritis & Rheumatology Associates, P.C., Denton
El Paso Medical Research Institute (MedResearch, Inc), El Paso
Local Institution - 0051, Van Vleck (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.