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

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus (SLE)
• Interventions: Drug: Current standard of care treatment options

• Registration Number: NCT07175285
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-11-04
• Primary Completion: 2028-03-01
• Study Completion: 2032-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 223

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Current standard of care treatment options	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.

Primary Outcome Measures

Name	Time	Method
Number of of participants achieving Definition of Remission in Systemic Lupus Erythematosus (DORIS) at 6 months along with the 95% CI.	6 months

Secondary Outcome Measures

Name	Time	Method
Number of participants achieving drug-free Definition of Remission in Systemic Lupus Erythematosus (DORIS) remission	At 12, 24, 36, 48, and 60 months
Complete renal response (CRR) for participants with baseline lupus nephritis (LN)	At 6, 12, 24, 36, 48, and 60 months
Lupus-Low Disease Activity State (LLDAS) for participants with baseline Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥ 6	At 12, 24, 36, 48, and 60 months
Incidence and severity of flares, as assessed by Systemic Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) index	Up to 60 months
SLE Responder Index 4 (SRI-4) for participants with baseline Lupus Erythematosus Disease Activity Questionnaire (SLEDAI) ≥ 6	At 6, 12, 24, 36, 48, and 60 months
Change from baseline in proteinuria and estimated glomerular filtration rate (eGFR) - of those with high proteinuria and low eGFR	At 6, 12, 24, 36, 48, and 60 months
Change in 2012 Systemic Lupus Collaborating Clinics Criteria for SLE (SLICC) damage from baseline	At 12, 24, 36, 48, and 60 months
Number of participants that maintain remission status as assessed by DORIS, LLDAS, and SRI-4	At 6, 12, 24, 36, 48, and 60 months	Definition of Remission in Systemic Lupus Erythematosus (DORIS), Lupus-Low Disease Activity State (LLDAS) and SLE Responder Index 4 (SRI-4)
Duration of treatment response	Up to 60 months
Time to treatment response	Up to 60 months
Incidence of adverse events (AEs) including serious AEs	Up to 60 months
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) patient reported outcome (PRO) from baseline	Baseline, and at 6, 12, 24, 36, 48, and 60 months

Trial Locations

Locations (11)

Local Institution - 0035; 🇺🇸 San Diego, California, United States

Local Institution - 0034; 🇺🇸 Ann Arbor, Michigan, United States

Local Institution - 0039; 🇺🇸 Brooklyn, New York, United States

Local Institution - 0037; 🇺🇸 Durham, North Carolina, United States

Local Institution - 0029; 🇦🇷 San Miguel de Tucumán, Tucumán Province, Argentina

Local Institution - 0042; 🇧🇷 São Paulo, Brazil

Local Institution - 0038; 🇨🇦 Sherbrooke, Quebec, Canada

Local Institution - 0041; 🇩🇪 Kiel, Schleswig-Holstein, Germany

Local Institution - 0043; 🇩🇪 Mainz, Germany

Local Institution - 0036; 🇮🇱 Haifa, Israel

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