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

NCT07175285 | Recruiting FDA Drug

• 1 other identifier: CA061-1025
• Study Type: observational
• Target: 223
• Locations: 12 countries
• Sites: 54

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

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

Systemic lupus erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (11)

• 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

Study Arms (1)

Group 1

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.

Drug: Current standard of care treatment options

Interventions

Current standard of care treatment options DRUG

According to the product label

Group 1

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include individuals diagnosed with systemic lupus erythematosus (SLE) with inadequate response (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 therapy) to glucocorticoids and at least two immunosuppressants according to routine clinical practice

You may qualify if:

• 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 low complement proteins (C3 or C4)
• Participants with lupus nephritis (LN) meeting the study eligibility criteria must have had a renal biopsy per standard of care within 6 months (± 30 days) prior to signing the ICF, indicating the presence of active Class III or IV LN (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

You may not qualify if:

• Pregnant women
• Participants enrolled in concurrent interventional clinical trials involving investigational therapies or any other clinical trial
• Participant is unwilling or unable to comply with routine clinical follow-up necessary for collection of study data

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (54)

Local Institution - 0062

Mesa, Arizona, 85210, United States

NOT YET RECRUITING

Local Institution - 0054

La Jolla, California, 92093, United States

NOT YET RECRUITING

Local Institution - 0001

La Palma, California, 90623-1730, United States

NOT YET RECRUITING

Rheumatology Center of San Diego

San Diego, California, 92128-2551, United States

RECRUITING

Local Institution - 0063

Fort Lauderdale, Florida, 33309-1715, United States

NOT YET RECRUITING

Local Institution - 0061

Hollywood, Florida, 33021-6052, United States

NOT YET RECRUITING

LIFE Clinical Trials

Margate, Florida, 33063, United States

RECRUITING

Local Institution - 0068

Palm Beach Gardens, Florida, 33410, United States

NOT YET RECRUITING

Local Institution - 0069

Atlanta, Georgia, 30322-1013, United States

NOT YET RECRUITING

Local Institution - 0065

Willowbrook, Illinois, 60527, United States

NOT YET RECRUITING

Local Institution - 0064

Rockville, Maryland, 20850, United States

NOT YET RECRUITING

Local Institution - 0034

Ann Arbor, Michigan, 48109-5000, United States

NOT YET RECRUITING

AA MRC

Grand Blanc, Michigan, 48439-2451, United States

RECRUITING

Local Institution - 0070

Kalispell, Montana, 59901-3129, United States

NOT YET RECRUITING

Sahni Rheumatology & Therapy

West Long Branch, New Jersey, 07764, United States

RECRUITING

Kings County Hospital Center - Brooklyn

Brooklyn, New York, 11203, United States

RECRUITING

DJL Clinical Research, PLLC

Charlotte, North Carolina, 28211, United States

RECRUITING

Local Institution - 0037

Durham, North Carolina, 27710-1000, United States

NOT YET RECRUITING

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104-5005, United States

RECRUITING

Local Institution - 0052

Philadelphia, Pennsylvania, 19140, United States

NOT YET RECRUITING

Local Institution - 0067

Murfreesboro, Tennessee, 37128, United States

NOT YET RECRUITING

Arthritis Care of Texas - Corpus Christi

Corpus Christi, Texas, 78415, United States

RECRUITING

El Paso Medical Research Institute (MedResearch, Inc)

El Paso, Texas, 79902-4821, United States

RECRUITING

Local Institution - 0051

Van Vleck, Texas, 77482, United States

NOT YET RECRUITING

Instituto Médico CER

Quilmes, Buenos Aires, B1878DVB, Argentina

RECRUITING

Centro de Investigaciones Medicas Tucuman

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

RECRUITING

Organización Médica de Investigación (OMI)

Buenos Aires, C1015ABO, Argentina

RECRUITING

Instituto De Reumatologia - IR Medical Center - Hospital de Dia

Mendoza, M5500CPH, Argentina

RECRUITING

Local Institution - 0042

São Paulo, 05403-000, Brazil

NOT YET RECRUITING

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Local Institution - 0038

Sherbrooke, Quebec, J1G 2E8, Canada

NOT YET RECRUITING

CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

RECRUITING

Local Institution - 0044

Paris, 75012, France

NOT YET RECRUITING

Local Institution - 0041

Kiel, Schleswig-Holstein, 24105, Germany

NOT YET RECRUITING

Local Institution - 0043

Mainz, 55131, Germany

NOT YET RECRUITING

Meir Medical Center

Kfar Saba, M, 4428164, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, TA, 5262000, Israel

RECRUITING

Rambam Medical Center

Haifa, 31096, Israel

RECRUITING

Carmel Medical Center

Haifa, 34362, Israel

RECRUITING

Rabin Medical Center - Hasharon Hospital

Petah Tikva, 4941492, Israel

RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna

Ferrara, RE, 44124, Italy

RECRUITING

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, TO, 10128, Italy

RECRUITING

ASST degli Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Local Institution - 0049

Kitakyushu-shi, Fukuoka, 807-8555, Japan

NOT YET RECRUITING

Local Institution - 0053

Sendai, Miyagi, 980-8574, Japan

NOT YET RECRUITING

Local Institution - 0055

Wakayama, 641-8510, Japan

NOT YET RECRUITING

Local Institution - 0046

San Juan, PR, 00917-3104, Puerto Rico

NOT YET RECRUITING

Hospital de Merida

Mérida, Badajoz, 6800, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Local Institution - 0056

Oxford, OXF, OX3 7LE, United Kingdom

NOT YET RECRUITING

Local Institution - 0058

Bath, SOM, BA1 3NG, United Kingdom

NOT YET RECRUITING

Local Institution - 0045

Wolverhampton, West Midlands, WV10 0QP, United Kingdom

NOT YET RECRUITING

Local Institution - 0059

London, NW3 2QG, United Kingdom

NOT YET RECRUITING

Local Institution - 0057

London, SE5 9RS, United Kingdom

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): March 24, 2028
• Study Completion (Estimated): October 5, 2032
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); CA (2); IL (5); DE (2); IT (3); ES (2); US (24); BR (1); FR (2); GB (5); AR (4); JP (3)