RecruitingOBSERVATIONAL

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

This research study is for people in the UK who have severe systemic lupus erythematosus (SLE), also known as lupus, especially when it involves the kidneys (lupus nephritis). If your lupus hasn't improved enough with steroid medications and at least two other immune-suppressing drugs, including a biologic, this study might be relevant. The main aim is to carefully examine how well current standard treatments work and if they cause any side effects in patients like you. This will help doctors understand the best ways to care for people with challenging lupus. It's about gathering information on existing treatment options rather than testing new ones.

At a glance

Status

Recruiting

Sponsor

Bristol-Myers Squibb

Enrolment target

223

Start

08 Oct 2025

Estimated completion

05 Oct 2032

Systemic Lupus Erythematosus (SLE)

What is this study about?

This study is designed for individuals living with Systemic Lupus Erythematosus (SLE), commonly known as lupus, particularly when the disease is active and hasn't responded adequately to standard treatments. Lupus is a long-term (chronic) condition where your body's immune system mistakenly attacks its own tissues and organs. This can cause a wide range of symptoms, from joint pain and skin rashes to more serious problems affecting organs like the kidneys, heart, and brain.

The focus of this research is to investigate the effectiveness and safety of the current standard treatment options for people whose lupus is active and hasn't improved sufficiently with typical medications. This includes those who have already tried steroid medications and at least two different immune-suppressing drugs, one of which was a 'biologic' therapy. The study also includes people whose kidneys are affected by lupus (lupus nephritis).

By carefully observing participants and their responses to these established treatments, the study aims to gather important information. This data will help medical professionals better understand how these treatments work in real-world settings for people with severe and hard-to-treat lupus. Ultimately, this knowledge can contribute to improving treatment strategies and patient care in the future.

Key takeaways

This study explores standard lupus treatments, not new experimental ones.
It's for people with active lupus that hasn't responded well to usual medicines.
A main goal is to understand how well current treatments work and their safety.
Includes people with kidney involvement (lupus nephritis).
Participation involves monitoring your response to your existing care.

Who may be eligible?

To join this study, you need to be at least 16 years old. You must have a confirmed diagnosis of systemic lupus erythematosus (SLE) based on specific medical criteria used by doctors.

Critically, your lupus must be active at the time you consider joining the study and must not have responded well enough to previous treatments. This means you would have already tried steroid medications and at least two other types of immune-suppressing drugs (one of which should be a biologic therapy), each for at least three months. If you have kidney involvement (lupus nephritis), your kidney biopsy results from the last six months must show a specific type of active inflammation and not too much scarring.

The study also requires that you have certain positive blood tests, called autoantibodies, which help confirm your lupus diagnosis. If you have any questions about these requirements, please speak to your doctor or the study team.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 16 years old or older?
Do you have a doctor-diagnosed case of Systemic Lupus Erythematosus (SLE)?
Is your lupus currently active, despite your current medications?
Have you previously tried steroid medication and at least two other immune-suppressing drugs (including a biologic) for your lupus, with limited success?
If you have kidney lupus (lupus nephritis), have you had a recent kidney biopsy showing active inflammation?

Answer every question to see your result.

What does participation involve?

This study focuses on observing your response to your current standard of care treatments rather than providing new investigational drugs. Taking part would involve regular check-ups and assessments to monitor your health and how your lupus responds to your existing medications. The exact number of visits and tests will be explained to you in detail by the study team. You would continue to receive your standard lupus treatments as prescribed by your doctor. The total duration of your participation would also be clearly outlined, including any follow-up appointments.

Potential risks and benefits

Participating in this study might help doctors better understand how standard lupus treatments work in people with severe, active disease, potentially contributing to improved care for others in the future. As the study focuses on standard treatments, your individual benefits would be similar to continuing your usual medical care. The risks involved are generally associated with your ongoing lupus treatment and any procedures for monitoring your health, such as blood tests, which will be fully explained. You are always free to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (62)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Local Institution - 0062
Verified postcode
Mesa, United States· Not yet recruiting
Local Institution - 0054
Verified postcode
La Jolla, United States· Not yet recruiting
Local Institution - 0001
Verified postcode
La Palma, United States· Not yet recruiting
Local Institution - 0071
Verified postcode
Los Angeles, United States· Not yet recruiting
Rheumatology Center of San Diego
Verified postcode
San Diego, United States· Recruiting
Local Institution - 0063
Verified postcode
Fort Lauderdale, United States· Not yet recruiting
South Florida Rheumatology
Verified postcode
Hollywood, United States· Recruiting
LIFE Clinical Trials
Verified postcode
Margate, United States· Recruiting
One- Rheumatology
Verified postcode
Palm Beach Gardens, United States· Recruiting
Local Institution - 0069
Verified postcode
Atlanta, United States· Not yet recruiting
Local Institution - 0065
Verified postcode
Willowbrook, United States· Not yet recruiting
Local Institution - 0064
Verified postcode
Rockville, United States· Not yet recruiting

Common questions

What is 'standard of care treatment'?

This refers to the best treatments currently accepted and widely used by doctors for a particular condition.

What does 'inadequate response' mean in this study?

It means your lupus hasn't improved enough, or the improvement hasn't lasted, even after trying standard medications like steroids and other immune-suppressing drugs.

What is a 'biologic therapy'?

Biologic therapies are medications made from natural sources, like proteins, that target specific parts of the immune system involved in diseases like lupus.

Will I get a new medicine if I join this study?

No, this study is observing current standard treatments, not testing a new experimental drug.

What is 'lupus nephritis'?

Lupus nephritis is when lupus affects your kidneys, causing inflammation and potentially impacting their function.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.