A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)
This study is for adults with Systemic Lupus Erythematosus (SLE). It's designed to see if a new medicine called BI 3000202 can help manage the condition and to find the best dose. Participants will be randomly assigned to receive either BI 3000202 at different doses or a placebo (a tablet with no active medicine) for one year, while also continuing their usual SLE treatments. Doctors will regularly monitor health and any side effects. By comparing the groups, researchers hope to understand if BI 3000202 is effective and safe, potentially offering a new treatment option for people living with SLE.
At a glance
What is this study about?
This study is looking into a new medicine called BI 3000202 for adults who have Systemic Lupus Erythematosus, often referred to simply as SLE or lupus. Lupus is a long-term condition that can affect many different parts of the body, and researchers are constantly working to find new and better ways to manage it. The main goal of this particular study is to find out if BI 3000202 can help people with lupus, and importantly, to work out what the most effective dose of this medicine might be.
To do this, participants will be divided into different groups by chance. Four of these groups will receive different doses of the new medicine, BI 3000202. The fifth group will receive a 'placebo', which looks exactly like the study medicine but doesn’t contain any active drug. This helps the researchers understand whether any improvements are truly due to the medicine or other factors. Everyone in the study will also continue taking their usual lupus medications, so the new medicine would be added on top of their existing treatment.
This type of study, known as a Phase 2 trial, is a crucial step in developing new medicines. It focuses on checking the safety of the new medicine and seeing if it has a positive effect on the condition. The information gathered will help determine if BI 3000202 should be studied further in larger groups of people, with the ultimate hope of providing a new treatment option for those living with lupus.
Key takeaways
- Tests a new medicine, BI 3000202, for adults with active lupus.
- Aims to find the best dose of the new medicine.
- Involves taking tablets daily for one year, alongside current lupus treatments.
- Participants are randomly assigned to different doses or a dummy medicine (placebo).
- Requires regular check-ups and monitoring of health and side effects.
- Total study involvement lasts just over one year.
Who may be eligible?
This study is for adults with a confirmed diagnosis of Systemic Lupus Erythematosus (SLE). You need to be between 18 and 74 years old and have specific blood test results that show your lupus is active. Your lupus must also be affecting you in a way that shows activity, as determined by the study doctors.
To join, you must already be on some standard lupus treatments, such as certain immunosuppressants or anti-malarial drugs, and these treatments need to have been stable for a number of weeks. If you are taking steroid tablets, your dose also needs to be stable and below a certain level. The study cannot include people whose lupus is mainly affecting their kidneys in a very specific, unstable way, or those with certain types of brain and nerve involvement from lupus.
There are some other conditions that might mean you can't join, such as having lupus that was caused by a medicine, or if you have certain other connective tissue diseases that might make it hard to tell if the study medicine is working for your 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 an adult aged 18 to 74 years old?
- Do you have a confirmed diagnosis of Systemic Lupus Erythematosus (lupus)?
- Are you currently on stable treatment for lupus (e.g., certain immunosuppressants, anti-malarial drugs, or low-dose steroids)?
- Do you have signs of active lupus that meet specific criteria outlined by the study doctors?
- Do you NOT have drug-induced lupus or specific severe lupus affecting your kidneys or brain/nerves?
What does participation involve?
If you decide to take part, you would be involved in the study for a little over a year. During this time, you would regularly visit the study site for check-ups with the doctors. The main part of the study involves taking tablets either at different doses of BI 3000202 or a placebo, once a day for a full year. You will continue to take all your current lupus medications as well.
During your visits, the study team will monitor your health closely, including carrying out various tests and asking about how you feel and any changes you notice. They will also keep an eye out for any unwanted effects the study medicine might be causing. Your overall health and how your lupus is responding will be carefully tracked. There will also be follow-up visits after you finish taking the study medicine to ensure your well-being.
Potential risks and benefits
Locations (134)
- Wallace & Lee CenterVerified postcodeBeverly Hills, United States· Not yet recruiting
- Arthritis & Osteoporosis Medical Center, Inc - La PalmaVerified postcodeLa Palma, United States· Not yet recruiting
- University of California San DiegoVerified postcodeSan Diego, United States· Not yet recruiting
- The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterVerified postcodeTorrance, United States· Not yet recruiting
- Inland Rheumatology Clinical Trials, IncVerified postcodeUpland, United States· Not yet recruiting
- Focus Clinical ResearchVerified postcodeWest Hills, United States· Not yet recruiting
- Denver Arthritis Clinic - LowryVerified postcodeDenver, United States· Not yet recruiting
- AARDS Research, Inc.Verified postcodeAventura, United States· Not yet recruiting
- Meris Clinical Research-Brandon-69466Verified postcodeBrandon, United States· Not yet recruiting
- Clinical Research of West Florida, Inc.Verified postcodeClearwater, United States· Not yet recruiting
- Integral Rheumatology and Immunology SpecialistVerified postcodePlantation, United States· Not yet recruiting
- Clinical Research of West Florida, Inc. - TampaVerified postcodeTampa, United States· Not yet recruiting
Common questions
What is Systemic Lupus Erythematosus (SLE)?
SLE, or lupus, is a long-term condition where the body's immune system mistakenly attacks its own tissues and organs. It can affect many parts of the body, so symptoms can vary greatly from person to person.
What is a placebo?
A placebo is a tablet that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers understand if the new medicine is truly effective or if improvements are due to other factors.
Will I know if I'm getting the study medicine or the placebo?
No, neither you nor your study doctors will know if you are receiving the active medicine or the placebo. This is called 'blinding' and helps ensure the study results are unbiased.
Do I have to stop my current lupus medications if I join?
No, you will continue taking your regular lupus treatments throughout the study. The new medicine, BI 3000202, would be taken in addition to your existing medications.
How long will I be involved in the study?
You would be involved in the study for a bit longer than one year, including the period of taking the tablets and follow-up visits.
How to find out more
Boehringer Ingelheim
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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