Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus

This research study is investigating a new medication, deucravacitinib, for people living with a serious form of lupus called Systemic Lupus Erythematosus (SLE). The main goal is to find out if this medicine is both safe and effective in improving the condition for those with moderate to severe symptoms. To do this, some participants will receive deucravacitinib, while others will receive a placebo, which looks like the study drug but contains no active medicine. This comparison helps researchers understand the true benefits of the new treatment. The study is open to adults between 18 and 75 years old.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

513

Start

12 Jan 2023

Estimated completion

13 Nov 2028

Systemic Lupus Erythematosus

What is this study about?

This study is all about helping people who have Systemic Lupus Erythematosus, often just called lupus. Lupus is a long-term condition that can affect many parts of the body, causing symptoms like joint pain, rashes, and tiredness. Researchers are testing a new medicine called deucravacitinib to see if it can reduce these symptoms and improve the health of people with active, moderate to severe lupus. In this type of study, participants are carefully monitored to make sure they are safe and that the information gathered is accurate.

The study is designed as a 'Phase 3' trial, which means the medicine has already gone through earlier testing and shown some promise. Now, it's being tested on a larger group of people to confirm its effectiveness and safety before it can be considered for wider use. By comparing deucravacitinib to a 'placebo' (a dummy pill with no active medicine), doctors can clearly tell if any improvements are due to the new drug or just other factors.

Taking part in a study like this is a way to contribute to medical science and potentially help yourself and others with lupus in the future. It's an opportunity to receive dedicated medical attention and potentially access a new treatment that isn't yet widely available.

Key takeaways

This study evaluates a new medicine (deucravacitinib) for moderate to severe lupus (SLE).
It compares the new medicine to a dummy pill (placebo) to see if it's safe and effective.
Participation involves regular clinic visits, blood tests, and taking study medication.
Adults aged 18-75 with an active SLE diagnosis are potentially eligible.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you need to meet certain conditions. You must be an adult between 18 and 75 years old and have been diagnosed with Systemic Lupus Erythematosus (SLE) for at least 24 weeks. Your lupus needs to be active, meaning you have ongoing symptoms affecting your joints or skin, or other signs of active disease.

You also need to have specific blood test results that help confirm your lupus, such as a positive ANA, anti-dsDNA, or anti-Smith test. Importantly, if you're taking medicine for your lupus, like immunosuppressants or antimalarial drugs, these generally need to have been at a stable dose for a certain period before you start the study. Taking steroid tablets is also allowed, as long as the dose is stable and not too high.

There are also reasons why you might not be able to join. For example, if your lupus was caused by a medicine (drug-induced lupus) or if you have other serious autoimmune conditions like rheumatoid arthritis or multiple sclerosis, you likely won't be eligible. The study also excludes people with active nervous system problems from lupus.

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 between 18 and 75 years old?
Have you been diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks ago?
Do you have active lupus symptoms, such as joint pain or rashes, that are moderate to severe?
Are you able to maintain your current lupus medications (if any) at a stable dose during the study?
Do you have certain specific lupus antibody markers in your blood?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new study medicine, deucravacitinib, or a placebo (a dummy pill). You wouldn't know which one you are getting, and neither would your study doctor, as this helps make sure the results are fair. You would have regular visits to the clinic for check-ups, blood tests, and to discuss any symptoms or side effects you might be having. These visits are important for monitoring your health and the effectiveness of the treatment.

The study involves taking the assigned medication regularly as instructed. The total duration of your participation in the study, including follow-up, would be fully explained by the study team. Throughout the study, your current lupus medications would need to remain stable, though some adjustments might be allowed under the guidance of the study doctors.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as receiving dedicated medical care and access to a new treatment that might improve your lupus symptoms. However, there are also potential risks, including side effects from the study medication, which the study team will explain in detail. The placebo group won't receive the active drug, so they won't get its benefits, but they also won't experience its specific side effects. You have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (180)

Local Institution - 0063
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La Jolla, United States
Local Institution - 0241
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La Mesa, United States
Local Institution - 0242
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San Diego, United States
Local Institution - 0143
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San Leandro, United States
Local Institution - 0147
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Santa Monica, United States
Local Institution - 0213
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Clearwater, United States
Local Institution - 0059
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Jacksonville, United States
Local Institution - 0075
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Margate, United States
Local Institution - 0007
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Oakland Park, United States
Local Institution - 0239
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Plant City, United States
Emory University School of Medicine- Grady Campus
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Atlanta, United States
Local Institution - 0137
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Marietta, United States

Common questions

What is Systemic Lupus Erythematosus (SLE)?

SLE is a long-term condition where your body's immune system mistakenly attacks its own healthy tissues, leading to inflammation and damage in various parts of the body.

What is a 'placebo'?

A placebo is a 'dummy pill' that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers understand if the new medicine truly works better than doing nothing or getting a standard treatment.

What does 'Phase 3' mean for a study?

Phase 3 means the medicine has already shown promise in earlier tests and is now being studied in a larger group of people to confirm its effectiveness and safety before it can be considered for approval.

Will I know if I'm getting the new medicine or the placebo?

No, in this type of study, neither you nor your study doctor will know whether you are receiving the new medicine or the placebo. This helps ensure the study results are unbiased and reliable.

Can I stop participating in the study at any time?

Yes, absolutely. You have the right to withdraw from the study at any point, for any reason, without it affecting your medical care.