A Multi-Center Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Systemic Lupus Erythematosus
This study is investigating a new tablet called BMS-986165 for Systemic Lupus Erythematosus (lupus), a condition where the body's immune system attacks its own tissues. The main goal is to find out if the new treatment is safe for people to take over a long period. Researchers will also be checking how well it helps manage lupus symptoms. Participants will be given either the new tablet at different strengths or a 'dummy' tablet (placebo) that looks the same but contains no medicine. This helps researchers understand the true effects of the new treatment. This is an early stage study (Phase II), focused on exploring its effects in more detail.
At a glance
What is this study about?
This research study is focused on a health condition called Systemic Lupus Erythematosus, often shortened to lupus. Lupus is a long-term (chronic) illness where the body's own defense system, called the immune system, mistakenly attacks healthy tissues in various parts of the body, such as joints, skin, kidneys, and other organs. This can lead to a wide range of symptoms, including pain, tiredness, skin rashes, and swelling.
The study is testing a new medicine, given as a tablet, called BMS-986165. The main purpose is to see how safe this new medicine is when taken over a longer period. This means doctors will be closely watching for any unwanted side effects that people might experience. They also want to understand if the medicine helps improve lupus symptoms and overall health.
By carefully comparing people who take the new medicine with those who take a 'dummy' tablet (placebo), researchers can get a clear picture of how effective and safe BMS-986165 truly is. This is an important step in developing new treatments for lupus that could potentially help many people.
Key takeaways
- This study evaluates a new tablet, BMS-986165, for lupus.
- It aims to understand long-term safety and how well it works.
- Participants will receive either the new medicine or a dummy tablet.
- Close medical monitoring for side effects and lupus symptoms will happen.
- It's an early-stage study (Phase II) exploring the treatment.
- Your participation helps advance understanding of lupus treatments.
Who may be eligible?
To join this study, participants must be at least 18 years old. There is no upper age limit, meaning older adults can also be considered.
Crucially, all participants must have an official diagnosis of Systemic Lupus Erythematosus (lupus) before they can be considered for enrolment in the study. Both men and women are welcome to take part.
Beyond these basic requirements, there will be other specific medical checks and criteria that doctors will need to review to make sure the study is right and safe for you. These might include checking your current lupus symptoms, your other health conditions, and any other medications you are taking.
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 18 years old or older?
- Have you been diagnosed with Systemic Lupus Erythematosus (lupus)?
- Are you able to take study medication as a tablet?
- Are you willing and able to attend regular clinic visits and appointments?
What does participation involve?
If you decide to take part in this study, you will be given one of four options for treatment: a dummy tablet (placebo) or the new medicine (BMS-986165) in one of three different strengths (3 mg, 6 mg, or 12 mg). You won't know which one you are taking. You will need to attend regular appointments at the study clinic. During these visits, doctors and nurses will closely monitor your health by checking your vital signs (like blood pressure and heart rate) and taking blood and urine samples for various tests.
They will also ask you questions about how you are feeling, any symptoms you are experiencing, and any side effects. You'll complete questionnaires about your quality of life and be checked for lupus flare-ups. The duration of your participation in the study and the exact schedule of visits will be explained in detail by the study team.
Potential risks and benefits
Locations (4)
- —UnverifiedRomania
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- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What is Systemic Lupus Erythematosus?
It's a long-term condition where your body's immune system mistakenly attacks its own healthy tissues and organs.
What does 'Phase II study' mean?
It means this is an early stage of research, where doctors are trying to understand more about the medicine's safety and effectiveness in people.
What is a 'placebo'?
A placebo is a 'dummy' tablet that looks identical to the actual medicine but contains no active drug. It helps researchers compare the real effects of the new treatment.
Will I know if I'm getting the new medicine or the placebo?
No, during the study, neither you nor your study doctor will know which treatment you are receiving. This is called 'blinding' and helps ensure the study results are fair and unbiased.
How long will the study last?
The study aims to look at the long-term effects of the medicine. The exact duration for each participant will be explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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