A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Gluc… (NCT07175285) | Clinical Trial Compass
RecruitingNot Applicable
A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants
United States223 participantsStarted 2025-10-08
Plain-language 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
Who can participate
Age range16 Years
SexALL
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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…
What they're measuring
1
Number of of participants achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) at 6 months along with the 95% CI.
Timeframe: 6 months
Trial details
NCT IDNCT07175285
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeOBSERVATIONAL
Primary completion2028-03-24
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com