A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants (BENCHMARK-SLE)

Bristol-Myers Squibb (BMS)

Status: Enrolling

Conditions: Systemic Lupus Erythematosus (SLE)

Treatments: Drug: Current standard of care treatment options

Study type: Observational

Funder types: Industry

Identifiers

NCT07175285

CA061-1025

Details and patient eligibility

About

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

Enrollment: 223 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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 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

• 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 (C3 or C4)

• 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

• Pregnant women
• Participants enrolled in concurrent interventional clinical trials involving investigational therapies or any other clinical trial
• Participant is unwilling and unable to adhere to the study visit schedule and other protocol requirements

Trial design

223 participants in 1 patient group

Group 1

Description:

Participants with systemic lupus erythematosus (SLE), including Lupus Nephritis, with inadequate response to glucocorticoids and at least 2 immunosuppressants, receiving current standard of care treatment options.

Treatment:

Drug: Current standard of care treatment options