Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Menu

Search BMS Clinical Trials
BMS Not Yet Recruiting Study icon

Not Yet Recruiting

Trial ID CA061-1025  |   NCT07175285

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

Warning icon
Sorry, this study is not yet accepting participants.
Please bookmark this page to check back at a later date.  You may also click the “Check Your Eligibility” button and answer a few questions about your health to find out if you might be a match to another study.
Check Your Eligibility

Summary

  • Male and Female Gender icon
  • 16+
    Age Range
  • 10
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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

print Print
email Email

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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
    1. Participants must be ≥16 years of age at the time of signing the ICF
      1. Meet the European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2019 classification criteria for systemic lupus erythematosus (SLE)
        1. Have an inadequate response to glucocorticoids and ≥ 2 immunosuppressant therapies such as cyclophosphamide, mycophenolic acid and its derivatives, belimumab, anifrolumab, rituximab, methotrexate, azathioprine, obinutuzumab, cyclosporine, tacrolimus, or voclosporin, 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
          1. Have active disease at study entry when signing ICF, defined as:
            1. ≥ 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
              1. 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 (C3 or C4)
                1. Participants with lupus nephritis meeting the study eligibility criteria must have had a renal biopsy per standard of care within the last 6 months indicating the presence of active Class III or IV lupus glomerulonephritis (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

                  Exclusion Criteria Icon
                  :
                  • Pregnant women
                    1. Participants enrolled in concurrent interventional clinical trials involving investigational therapies or any other clinical trial
                      1. Participant is unwilling and unable to adhere to the study visit schedule and other protocol requirements
                        Additional Information *

                        Treatment Options

                        Study Arms

                        ASSIGNED INTERVENTION

                        Study Arms

                        Group 1

                        ASSIGNED INTERVENTION
                        Please check back later for a recruiting site or find another trial by clicking 'Check Your Eligibility'
                        Check Your Eligibility
                        Answer some questions about Your health to see if you may match to this trial
                        Match to a Trial
                        If you are a match, click on the study to see the list of study site locations.
                        Select a Study Site Location
                        Select a study site location that is convenient for you
                        Register
                        Provide your contact details for the study site to connect with you.

                        Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you

                        Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you