Randomised, placebo-controlled, double-blind, parallel-group Phase II study to evaluate the efficacy and safety of oral BI 3000202 in patients with moderate to severe systemic lupus erythematosus (SLE)
This research study is looking at a new potential medicine called BI 3000202 for adults who have a type of lupus called systemic lupus erythematosus (SLE) that is moderate to severe. The main goal is to find out if this new medicine can help improve lupus symptoms and if it is safe to use. Half of the participants will receive the new medicine, while the other half will receive a 'dummy' pill (placebo) that looks the same but contains no active medicine. This helps researchers compare the effects accurately. The study is planned to follow participants for about 32 weeks to see how they respond to treatment. It's a key step to see if this medicine could become a future treatment option for lupus.
At a glance
What is this study about?
This study is a research project looking into a new unapproved medicine called BI 3000202 for people who have a condition called systemic lupus erythematosus (SLE). SLE is a long-term illness where your body's immune system mistakenly attacks its own healthy tissues, leading to inflammation and damage in various parts of the body, like joints, skin, kidneys, and heart. The study focuses on people whose lupus is considered moderate to severe.
The main aim of this study is to see if BI 3000202 can help reduce the symptoms and signs of lupus more effectively than a dummy pill (placebo). It's also very important to check if the new medicine is safe and doesn't cause too many side effects. In medical research, this type of study is called a 'Phase II' study, meaning it's an important early step in testing a new medicine in a small group of people with the condition. If the results are promising, it might move on to larger studies.
To make sure the results are fair and accurate, this study is 'randomised,' meaning participants are assigned to receive either the new medicine or the dummy pill by chance, like flipping a coin. It’s also 'double-blind,' which means neither you nor your study doctor will know whether you are receiving the new medicine or the dummy pill. This helps prevent anyone's expectations from influencing the results. The 'parallel-group' part means that people in the medicine group and people in the dummy pill group will be studied at the same time and compared against each other.
Key takeaways
- New medicine BI 3000202 being tested for moderate to severe lupus.
- Study compares new medicine to a dummy pill (placebo).
- Neither you nor doctor will know what treatment you receive.
- Main goal is to see if symptoms improve and medicine is safe over 32 weeks.
- Participation involves regular clinic visits for checks and tests.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. The study is open to both men and women.
You would need to have been diagnosed with systemic lupus erythematosus (SLE), and your lupus would need to be considered moderate to severe by the study doctors.
There will be other, more detailed health checks and requirements that the study team will go through with you if you're interested. These checks help make sure the study is safe for you and that the results will be clear. For example, they'll check you don't have other health conditions or are taking medicines that might interfere with the study medicine.
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 (SLE)?
- Do doctors consider your lupus to be moderate to severe?
- Are you able to attend regular clinic appointments for about 8 months?
What does participation involve?
If you decide to take part, the study will last about 32 weeks, which is roughly 8 months. During this time, you will have regular visits to the clinic. These visits will involve various checks, such as physical exams, blood tests, and possibly urine tests, to monitor your health and how you're responding to the treatment. You would likely take the study medication (either BI 3000202 or the dummy pill) by mouth, as prescribed.
After the initial 32 weeks, there might be a follow-up period to see how you are doing in the longer term. The exact number of visits and tests will be explained in detail by the study team. You would also need to keep track of any symptoms or side effects you experience.
Potential risks and benefits
Locations (7)
- —UnverifiedBulgaria
- —UnverifiedRomania
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedPoland
- —UnverifiedCroatia
Common questions
What is systemic lupus erythematosus (SLE)?
SLE, or lupus, is a long-term condition where your body's immune system attacks healthy tissues, causing inflammation and damage in various parts of the body.
What does 'Phase II study' mean?
It means this is an early stage of testing a new medicine in a small group of people to see if it works and is safe, before larger studies begin.
What does 'double-blind' mean?
It means neither you nor your study doctor will know if you are receiving the new medicine or a dummy pill, to ensure fair results.
Will I definitely get the new medicine?
No, you will be randomly assigned to receive either the new medicine or a dummy pill (placebo); it's like a coin flip.
How long will I be in the study?
The main part of the study where you receive treatment will last about 32 weeks, or roughly 8 months, with possible follow-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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