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

Last updated: May 15, 2026
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

N/A

Condition

Systemic Lupus Erythematosus

Cutaneous Lupus Erythematosus

Lupus

Treatment

Current standard of care treatment options

Clinical Study ID

NCT07175285
CA061-1025
  • Ages > 16
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants must have signed and dated an Institutional Review Board/ IndependentEthics Committee (IRB/IEC)-approved written informed consent form (ICF) inaccordance 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 ofRheumatology (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 atleast 3 months each. Eligibility is regardless of prior hydroxychloroquine or anyanti-malarial treatment. Inadequate response is defined as a lack of response,insufficient response, or lack of sustained response after at least 3-monthtreatment with appropriate doses of a standard of care agent. Intolerance orcontraindication may be considered as inadequate response provided it is documentedand 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 withhistory 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: Antinuclearantibody ≥1:160, anti-dsDNA, anti-Sm, anti-Ro (SSA), anti-La (SSB), or lowcomplement proteins (C3 or C4)

  • Participants with lupus nephritis (LN) meeting the study eligibility criteria musthave had a renal biopsy per standard of care within 6 months (± 30 days) prior tosigning the ICF, indicating the presence of active Class III or IV LN (alone or incombination with Class V) according to the 2018 Revised International Society ofNephrology/Renal Pathology Society (ISN/RPS), with < 60% interstitial fibrosis andtubular atrophy < 60% global glomerulosclerosis

Exclusion

Exclusion Criteria:

  • Pregnant women

  • Participants enrolled in concurrent interventional clinical trials involvinginvestigational therapies or any other clinical trial

  • Participant is unwilling or unable to comply with routine clinical follow-upnecessary for collection of study data

Study Design

Total Participants: 223
Treatment Group(s): 1
Primary Treatment: Current standard of care treatment options
Phase:
Study Start date:
October 08, 2025
Estimated Completion Date:
October 05, 2032

Connect with a study center

  • Instituto Médico CER

    Quilmes, Buenos Aires B1878DVB
    Argentina

    Active - Recruiting

  • Centro de Investigaciones Medicas Tucuman

    San Miguel de Tucumán, Tucumán Province T4000AXL
    Argentina

    Active - Recruiting

  • Local Institution - 0029

    San Miguel de Tucumán 3836873, Tucumán Province 3833578 T4000AXL
    Argentina

    Site Not Available

  • Organización Médica de Investigación (OMI)

    Buenos Aires, C1015ABO
    Argentina

    Active - Recruiting

  • Local Institution - 0050

    Buenos Aires 3435910, C1015ABO
    Argentina

    Site Not Available

  • Instituto De Reumatologia - IR Medical Center - Hospital de Dia

    Mendoza, M5500CPH
    Argentina

    Active - Recruiting

  • Local Institution - 0042

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Local Institution - 0042

    São Paulo 3448439, 05403-000
    Brazil

    Site Not Available

  • St. Joseph's Hospital

    London, Ontario N6A 4V2
    Canada

    Active - Recruiting

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • The Ottawa Hospital - General Campus

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Site Not Available

  • Local Institution - 0038

    Sherbrooke, Quebec J1G 2E8
    Canada

    Site Not Available

  • Local Institution - 0038

    Sherbrooke 6146143, Quebec 6115047 J1G 2E8
    Canada

    Site Not Available

  • Local Institution - 0044

    Paris, Île-de-France Region 75012
    France

    Site Not Available

  • CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux, 33076
    France

    Active - Recruiting

  • Local Institution - 0023

    Bordeaux, 33076
    France

    Site Not Available

  • Local Institution - 0023

    Bordeaux 3031582, 33076
    France

    Site Not Available

  • Local Institution - 0044

    Paris 2988507, 75012
    France

    Site Not Available

  • Local Institution - 0041

    Kiel, Schleswig-Holstein 24105
    Germany

    Site Not Available

  • Local Institution - 0041

    Kiel 2891122, Schleswig-Holstein 2838632 24105
    Germany

    Site Not Available

  • Local Institution - 0043

    Mainz, 55131
    Germany

    Site Not Available

  • Local Institution - 0043

    Mainz 2874225, 55131
    Germany

    Site Not Available

  • Meir Medical Center

    Kfar Saba, M 4428164
    Israel

    Active - Recruiting

  • Meir Medical Center

    Kfar Saba 294514, M 4428164
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, TA 5262000
    Israel

    Active - Recruiting

  • Carmel Medical Center

    Haifa, 34362
    Israel

    Active - Recruiting

  • Rambam Medical Center

    Haifa, 31096
    Israel

    Active - Recruiting

  • Carmel Medical Center

    Haifa 294801, 34362
    Israel

    Active - Recruiting

  • Local Institution - 0036

    Haifa 294801, 34362
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa 294801, 31096
    Israel

    Site Not Available

  • Rabin Medical Center - Hasharon Hospital

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Local Institution - 0025

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

    Ferrara, RE 44124
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

    Ferrara 3177090, RE 44124
    Italy

    Site Not Available

  • Local Institution - 0040

    Ferrara 3177090, RE 44124
    Italy

    Site Not Available

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, TO 10128
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino 8980539, TO 10128
    Italy

    Site Not Available

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Local Institution - 0049

    Kitakyushu-shi, Fukuoka 807-8555
    Japan

    Site Not Available

  • Local Institution - 0053

    Sendai, Miyagi 980-8574
    Japan

    Site Not Available

  • Local Institution - 0053

    Sendai 2111149, Miyagi 2111888 980-8574
    Japan

    Site Not Available

  • Local Institution - 0055

    Wakayama, 641-8510
    Japan

    Site Not Available

  • Local Institution - 0055

    Wakayama 1926004, 641-8509
    Japan

    Site Not Available

  • Local Institution - 0046

    San Juan, PR 00917-3104
    Puerto Rico

    Site Not Available

  • Local Institution - 0046

    San Juan 4568127, PR 00917-3104
    Puerto Rico

    Site Not Available

  • Hospital de Merida

    Mérida, Badajoz 6800
    Spain

    Active - Recruiting

  • Local Institution - 0047

    Mérida 2513917, Badajoz 6800
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Local Institution - 0048

    Barcelona, 08036
    Spain

    Site Not Available

  • Local Institution - 0048

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Local Institution - 0072

    Lund, Skåne County SE-221 85
    Sweden

    Site Not Available

  • Local Institution - 0056

    Oxford, OXF OX3 7LE
    United Kingdom

    Site Not Available

  • Local Institution - 0056

    Oxford 2640729, OXF OX3 7LE
    United Kingdom

    Site Not Available

  • Local Institution - 0058

    Bath, SOM BA1 3NG
    United Kingdom

    Site Not Available

  • Royal National Hospital for Rheumatic Diseases-Bath

    Bath, SOM BA1 3NG
    United Kingdom

    Active - Recruiting

  • Local Institution - 0058

    Bath 2656173, SOM BA1 3NG
    United Kingdom

    Site Not Available

  • Local Institution - 0045

    Wolverhampton, West Midlands WV10 0QP
    United Kingdom

    Site Not Available

  • The Royal Wolverhampton NHS Trust - New Cross Hospital

    Wolverhampton, West Midlands WV10 0QP
    United Kingdom

    Active - Recruiting

  • Local Institution - 0045

    Wolverhampton 2633691, West Midlands WV10 0QP
    United Kingdom

    Site Not Available

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Local Institution - 0057

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Local Institution - 0059

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Local Institution - 0057

    London 2643743, SE5 9RS
    United Kingdom

    Site Not Available

  • Local Institution - 0059

    London 2643743, NW3 2QG
    United Kingdom

    Site Not Available

  • Local Institution - 0062

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Local Institution - 0062

    Mesa 5304391, Arizona 5551752 85210
    United States

    Site Not Available

  • Local Institution - 0054

    La Jolla, California 92093
    United States

    Site Not Available

  • Local Institution - 0001

    La Palma, California 90623-1730
    United States

    Site Not Available

  • Local Institution - 0071

    Los Angeles, California 90095
    United States

    Site Not Available

  • Rheumatology Center of San Diego

    San Diego, California 92128-2551
    United States

    Active - Recruiting

  • Local Institution - 0054

    La Jolla 5363943, California 5332921 92093
    United States

    Site Not Available

  • Local Institution - 0035

    San Diego 5391811, California 5332921 92128-2551
    United States

    Site Not Available

  • Rheumatology Center of San Diego

    San Diego 5391811, California 5332921 92128-2551
    United States

    Site Not Available

  • Local Institution - 0063

    Fort Lauderdale, Florida 33309-1715
    United States

    Site Not Available

  • Local Institution - 0061

    Hollywood, Florida 33021-6052
    United States

    Site Not Available

  • South Florida Rheumatology

    Hollywood, Florida 33021-6052
    United States

    Active - Recruiting

  • LIFE Clinical Trials

    Margate, Florida 33063
    United States

    Active - Recruiting

  • Local Institution - 0068

    Palm Beach Gardens, Florida 33410
    United States

    Site Not Available

  • One- Rheumatology

    Palm Beach Gardens, Florida 33410
    United States

    Active - Recruiting

  • Local Institution - 0063

    Fort Lauderdale 4155966, Florida 4155751 33309-1715
    United States

    Site Not Available

  • Local Institution - 0061

    Hollywood 4158928, Florida 4155751 33021-6052
    United States

    Site Not Available

  • LIFE Clinical Trials

    Margate 4163407, Florida 4155751 33063
    United States

    Site Not Available

  • Local Institution - 0069

    Atlanta, Georgia 30322-1013
    United States

    Site Not Available

  • Local Institution - 0065

    Willowbrook, Illinois 60527
    United States

    Site Not Available

  • Local Institution - 0065

    Willowbrook 4916709, Illinois 4896861 60527
    United States

    Site Not Available

  • Local Institution - 0064

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Local Institution - 0064

    Rockville 4367175, Maryland 4361885 20850
    United States

    Site Not Available

  • Local Institution - 0034

    Ann Arbor, Michigan 48109-5000
    United States

    Site Not Available

  • AA MRC

    Grand Blanc, Michigan 48439-2451
    United States

    Active - Recruiting

  • Local Institution - 0034

    Ann Arbor 4984247, Michigan 5001836 48109-5000
    United States

    Site Not Available

  • AA MRC

    Grand Blanc 4994320, Michigan 5001836 48439-2451
    United States

    Site Not Available

  • Local Institution - 0070

    Kalispell, Montana 59901-3129
    United States

    Site Not Available

  • Local Institution - 0060

    West Long Branch, New Jersey 07764
    United States

    Site Not Available

  • Sahni Rheumatology & Therapy

    West Long Branch, New Jersey 07764
    United States

    Active - Recruiting

  • Local Institution - 0060

    West Long Branch 5106275, New Jersey 5101760 07764
    United States

    Site Not Available

  • Kings County Hospital Center - Brooklyn

    Brooklyn, New York 11203
    United States

    Active - Recruiting

  • Kings County Hospital Center - Brooklyn

    Brooklyn 5110302, New York 5128638 11203
    United States

    Site Not Available

  • Local Institution - 0039

    Brooklyn 5110302, New York 5128638 11203
    United States

    Site Not Available

  • DJL Clinical Research, PLLC

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • Local Institution - 0037

    Durham, North Carolina 27710-1000
    United States

    Site Not Available

  • DJL Clinical Research, PLLC

    Charlotte 4460243, North Carolina 4482348 28211
    United States

    Site Not Available

  • Local Institution - 0037

    Durham 4464368, North Carolina 4482348 27710-1000
    United States

    Site Not Available

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma 73104-5005
    United States

    Active - Recruiting

  • Oklahoma Medical Research Foundation

    Oklahoma City 4544349, Oklahoma 4544379 73104-5005
    United States

    Site Not Available

  • Local Institution - 0052

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Local Institution - 0052

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Site Not Available

  • Local Institution - 0067

    Murfreesboro, Tennessee 37128
    United States

    Site Not Available

  • Local Institution - 0067

    Murfreesboro 4644312, Tennessee 4662168 37128
    United States

    Site Not Available

  • Arthritis Care of Texas - Corpus Christi

    Corpus Christi, Texas 78415
    United States

    Active - Recruiting

  • Local Institution - 0066

    Corpus Christi, Texas 78415
    United States

    Site Not Available

  • El Paso Medical Research Institute (MedResearch, Inc)

    El Paso, Texas 79902-4821
    United States

    Active - Recruiting

  • Local Institution - 0051

    Van Vleck, Texas 77482
    United States

    Site Not Available

  • Local Institution - 0066

    Corpus Christi 4683416, Texas 4736286 78415
    United States

    Site Not Available

  • El Paso Medical Research Institute (MedResearch, Inc)

    El Paso 5520993, Texas 4736286 79902-4821
    United States

    Site Not Available

  • Local Institution - 0051

    Van Vleck 4738908, Texas 4736286 77482
    United States

    Site Not Available

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