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Lupus patients who failed multiple drugs under observation in new study

NCT ID NCT07175285

Knowledge-focused Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This study is observing 223 people with active lupus (including kidney inflammation) who haven't gotten better with steroids and at least two immunosuppressants. Researchers want to see how well today's standard treatments work for these tough cases. The goal is to measure how many patients reach remission or low disease activity after 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 223 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Oct 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus (SLE)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    65 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AA MRC

    RECRUITING

    Grand Blanc, Michigan, 48439-2451, United States

  • ASST degli Spedali Civili di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Arthritis & Rheumatism Associates

    RECRUITING

    Rockville, Maryland, 20850, United States

  • Arthritis Care of Texas - Corpus Christi

    RECRUITING

    Corpus Christi, Texas, 78415, United States

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    RECRUITING

    Torino, TO, 10128, Italy

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

    RECRUITING

    Ferrara, RE, 44124, Italy

  • CHU Hopitaux de Bordeaux - Groupe Hospitalier Pellegrin

    RECRUITING

    Bordeaux, 33076, France

  • Carmel Medical Center

    RECRUITING

    Haifa, 34362, Israel

  • Centre for Rheumatology, Immunology and Arthritis

    RECRUITING

    Fort Lauderdale, Florida, 33309-1715, United States

  • Centre hospitalier de l'Université Laval

    RECRUITING

    Calgary, Alberta, T2T 5C7, Canada

  • Centro de Investigaciones Medicas Tucuman

    RECRUITING

    San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

  • DJL Clinical Research, PLLC

    RECRUITING

    Charlotte, North Carolina, 28211, United States

  • El Paso Medical Research Institute (MedResearch, Inc)

    RECRUITING

    El Paso, Texas, 79902-4821, United States

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital de Clinicas de Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital de Merida

    RECRUITING

    Mérida, Badajoz, 6800, Spain

  • Hospital of the University of Occupational and Environmental Health, Japan

    RECRUITING

    Kitakyushu-Shi, 807-8556, Japan

  • Hôpital Saint-Antoine

    RECRUITING

    Paris, Île-de-France Region, 75012, France

  • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre

    RECRUITING

    Strasbourg, 67098, France

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

    RECRUITING

    Mendoza, M5500CPH, Argentina

  • Instituto Médico CER

    RECRUITING

    Quilmes, Buenos Aires, B1878DVB, Argentina

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Kings County Hospital Center - Brooklyn

    RECRUITING

    Brooklyn, New York, 11203, United States

  • LIFE Clinical Trials

    RECRUITING

    Margate, Florida, 33063, United States

  • Local Institution - 0001

    NOT_YET_RECRUITING

    La Palma, California, 90623-1730, United States

  • Local Institution - 0007

    NOT_YET_RECRUITING

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Local Institution - 0025

    NOT_YET_RECRUITING

    Tel Aviv, 6423906, Israel

  • Local Institution - 0034

    NOT_YET_RECRUITING

    Ann Arbor, Michigan, 48109-5000, United States

  • Local Institution - 0037

    WITHDRAWN

    Durham, North Carolina, 27710-1000, United States

  • Local Institution - 0038

    NOT_YET_RECRUITING

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Local Institution - 0041

    NOT_YET_RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

  • Local Institution - 0042

    NOT_YET_RECRUITING

    São Paulo, 05403-000, Brazil

  • Local Institution - 0043

    NOT_YET_RECRUITING

    Mainz, 55131, Germany

  • Local Institution - 0046

    NOT_YET_RECRUITING

    San Juan, PR, 00917-3104, Puerto Rico

  • Local Institution - 0051

    NOT_YET_RECRUITING

    Van Vleck, Texas, 77482, United States

  • Local Institution - 0052

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Local Institution - 0054

    NOT_YET_RECRUITING

    La Jolla, California, 92093, United States

  • Local Institution - 0069

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30322-1013, United States

  • Local Institution - 0070

    NOT_YET_RECRUITING

    Kalispell, Montana, 59901-3129, United States

  • Local Institution - 0071

    NOT_YET_RECRUITING

    Los Angeles, California, 90095, United States

  • Local Institution - 0072

    NOT_YET_RECRUITING

    Lund, Skåne County, SE-221 85, Sweden

  • Local Institution - 0073

    NOT_YET_RECRUITING

    Solna, Stockholm County, 171 64, Sweden

  • Local Institution - 0074

    NOT_YET_RECRUITING

    Örebro, 701 85, Sweden

  • Local Institution - 0075

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Lone Star Arthritis & Rheumatology Associates, P.C.

    RECRUITING

    Denton, Texas, 76205, United States

  • Meir Medical Center

    RECRUITING

    Kfar Saba, M, 4428164, Israel

  • Murfreesboro Medical Clinic

    RECRUITING

    Murfreesboro, Tennessee, 37128, United States

  • Oklahoma Medical Research Foundation

    RECRUITING

    Oklahoma City, Oklahoma, 73104-5005, United States

  • One- Rheumatology

    RECRUITING

    Palm Beach Gardens, Florida, 33410, United States

  • Organización Médica de Investigación (OMI)

    RECRUITING

    Buenos Aires, C1015ABO, Argentina

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    RECRUITING

    Oxford, OXF, OX3 7LE, United Kingdom

  • Rabin Medical Center - Hasharon Hospital

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Medical Center

    RECRUITING

    Haifa, 31096, Israel

  • Rheumatology Center of San Diego

    RECRUITING

    San Diego, California, 92128-2551, United States

  • Royal National Hospital for Rheumatic Diseases-Bath

    RECRUITING

    Bath, SOM, BA1 3NG, United Kingdom

  • Sahni Rheumatology & Therapy

    RECRUITING

    West Long Branch, New Jersey, 07764, United States

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, TA, 5262000, Israel

  • South Florida Rheumatology

    RECRUITING

    Hollywood, Florida, 33021-6052, United States

  • St. Joseph's Hospital

    RECRUITING

    London, Ontario, N6A 4V2, Canada

  • The Ottawa Hospital - General Campus

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal Free London NHS Foundation Trust - The Royal Free Hospital

    RECRUITING

    London, NW3 2QG, United Kingdom

  • The Royal Wolverhampton NHS Trust - New Cross Hospital

    RECRUITING

    Wolverhampton, West Midlands, WV10 0QP, United Kingdom

  • Tohoku University Hospital

    RECRUITING

    Sendai, Miyagi, 980-8574, Japan

  • Toyama University

    RECRUITING

    Toyama, Toyama, 930-0887, Japan

  • Wakayama Medical University Hospital

    RECRUITING

    Wakayama, 641-8510, Japan

  • Willow Rheumatology & Wellness

    RECRUITING

    Willowbrook, Illinois, 60527, United States

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Other studies related to the condition(s) this trial covers.