Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsN/A

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

Sponsor: Bristol-Myers Squibb

NCT ID: NCT07175285

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Current standard of care treatment options (drug)
How long the study runs
Study runs about 84 months (dates as stated)
About the drug or intervention
Current standard of care treatment options — drug: According to the product label
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
16 Years and over
Who
All
Number of participants
223
Started
2025-10-08
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for systemic lupus erythematosus (sle)
  • • Clinical study - 223 participants
  • • 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

Who can take part?

  • • Ages 16 Years and over
  • • Diagnosed with systemic lupus erythematosus (sle)

Where?

  • • Oxford - Oxford University Hospitals NHS Trust - Churchill Hospital
  • • Bath - Royal National Hospital for Rheumatic Diseases-Bath
  • • Wolverhampton - The Royal Wolverhampton NHS Trust - New Cross Hospital
  • • London - The Royal Free London NHS Foundation Trust - The Royal Free Hospital
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Systemic Lupus Erythematosus (SLE)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ had a renal biopsy per standard of care within 6 months (± 30 days)

What the study is looking for

  • ✓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...
  • ✓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...
  • ✓Positive autoantibodies (at least one) to confirm diagnosis of SLE: Antinuclear antibody ≥1:160, anti-dsDNA,...

Who cannot take part

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

Where Is This Study? (5 UK sites)

Oxford University Hospitals NHS Trust - Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)
Anthony Psarras, Site 0056+441865270000

Royal National Hospital for Rheumatic Diseases-Bath

Bath BA1 3NG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Professor Julie Barnett (Associate Pro Vice-Chancellor, Research)

pro-vc-research@bath.ac.uk1225383162

The Royal Wolverhampton NHS Trust - New Cross Hospital

Wolverhampton WV10 0QP, United Kingdom

Recruiting
Site contact (verified)
Thomas Sheeran, Site 0045441213532444

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

London NW3 2QG, United Kingdom

Recruiting
Site contact (verified)
Shahir Hamdulay, Site 0059+2077940500

King's College Hospital NHS Foundation Trust

London SE5 9RS, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

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

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

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09