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Treatment outcomes for people with active SLE not helped by steroids and multiple immunosuppressants

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

Observational Bristol-Myers Squibb · NCT07175285

It will see how well current treatments work and how safe they are for people with active SLE who haven't had enough benefit from glucocorticoids and at least two immunosuppressant drugs.

Quick facts

Study typeObservational
Enrollment223 (estimated)
Ages16 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations54 sites (Mesa, Arizona and 53 other locations)
Trial IDNCT07175285 on ClinicalTrials.gov

What this trial studies

This is a multi-site observational cohort that collects clinical and safety data on standard-of-care treatments in people with active systemic lupus erythematosus, including lupus nephritis, who have had an inadequate response to glucocorticoids and at least two immunosuppressants. Eligible participants are 16 years and older, must meet the EULAR/ACR 2019 classification criteria, and must have shown inadequate or unsustained response after at least three months of appropriate dosing for each prior therapy, including one biologic. Investigators will record treatment regimens, disease activity measures, organ-specific outcomes, laboratory results, and adverse events during routine visits without assigning experimental therapies. Collected data will be used to characterize real-world effectiveness and safety across existing treatment options for this hard-to-treat SLE population.

Who should consider this trial

Good fit: People aged 16 and older with active SLE (including lupus nephritis) who meet the EULAR/ACR 2019 criteria and have shown inadequate response to glucocorticoids plus at least two immunosuppressants, one being a biologic, for at least three months each.

Not a fit: Patients whose disease is well controlled on initial therapies, those under 16, or those who have not tried the required combination and duration of immunosuppressant treatments are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help clinicians choose the most effective and safest existing therapies for people with hard-to-treat SLE.

How similar studies have performed: Similar observational registries and cohort studies have described outcomes of standard SLE therapies, but detailed real-world data specifically for patients failing steroids and multiple immunosuppressants remain limited.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Mesa, Arizona and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusSystemic lupus erythematosus
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.