(Synbiose-2 )Synergetic B-cell immunomodulation in SLE – 2 nd study
Systemic lupus erythematosus, usually called lupus or SLE, is a long-term condition where the immune system mistakenly attacks healthy tissues, causing inflammation and damage. In this study, called Synbiose-2, researchers are testing a new approach using two medicines at the same time: Benlysta and Truxima. Both medicines target white blood cells called B cells, which play a key role in causing lupus flares. While these drugs are already used individually, doctors want to know if combining them provides stronger, longer-lasting protection. Over two years, researchers will track how well this combination stops lupus from worsening, whether it reduces kidney damage, and if it allows patients to lower their doses of other strong medicines like steroids. The study will also carefully monitor patient safety and side effects throughout.
At a glance
What is this study about?
Systemic lupus erythematosus (SLE) is an autoimmune condition. Normally, your immune system protects you from bugs and illnesses. In people with lupus, the immune system gets confused and attacks healthy parts of the body instead. This can cause joint pain, skin rashes, extreme tiredness, and sometimes inflammation in vital organs like the kidneys.
A specific type of white blood cell, known as a B cell, is heavily involved in this process. These cells produce harmful proteins called autoantibodies that trigger inflammation. The Synbiose-2 clinical trial is looking at whether combining two targeted treatments—Benlysta and Truxima—can bring these rogue B cells under control more effectively than standard options.
Truxima is given as an infusion into a vein to quickly lower B-cell levels, while Benlysta is given as regular injections under the skin to keep them from bouncing back. Researchers hope that using them together will stop lupus flares in their tracks and protect kidney function. If successful, this combined approach could help people with lupus stay well for longer and reduce their need for high doses of steroids, which often carry difficult side effects.
Key takeaways
- The Synbiose-2 study is testing a combination of two targeted medicines (Benlysta and Truxima) for lupus.
- The main goal is to see if using both drugs together stops lupus flares and protects the kidneys over two years.
- Participation involves receiving hospital infusions and regular skin injections using a pre-filled pen.
- The trial is open to adults aged 18 and older who have systemic lupus erythematosus.
- Taking part is voluntary, and you can leave the study at any time without your normal care being affected.
Who may be eligible?
This study is open to adults aged 18 and over who have been diagnosed with systemic lupus erythematosus (SLE). Both men and women are welcome to take part.
To be considered, participants generally need to have active lupus that requires medical treatment. Doctors will look for certain markers in the blood, such as specific antibodies, and check how the condition is affecting organs like the kidneys.
Because the study medicines work by calming the immune system, you will have a thorough health check before joining. This ensures you do not have any active infections or other medical conditions that could make taking part unsafe.
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.
- I am at least 18 years old.
- I have been diagnosed with systemic lupus erythematosus (lupus/SLE).
- I am looking for new ways to manage my lupus symptoms under specialist care.
- I am able to attend regular hospital check-ups and blood tests over a two-year period.
- I do not currently have a serious, active infection.
What does participation involve?
Taking part in this study lasts for about two years (104 weeks). During the trial, you will receive Truxima as a drip into a vein (an intravenous infusion) at the clinic, and Benlysta as an injection under the skin using an easy-to-use pre-filled pen. You will attend regular hospital appointments so the study team can check on your health. These visits will include standard physical exams, blood tests, and urine tests to monitor your kidneys and immune system. The team will also track how your symptoms are doing, note any side effects, and see whether you can safely reduce your other lupus medications over time.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is the difference between the two study drugs?
Truxima works quickly to clear out overactive B cells through a hospital drip, while Benlysta is a regular injection that stops new harmful B cells from growing back.
How often will I need to visit the hospital?
You will need to visit the clinic regularly for treatment infusions, health checks, and routine blood tests, especially in the first few months of the study.
Will I have to stop my current lupus medications?
Not right away. The study team will review all your current medicines. Over time, doctors hope the study treatment may allow you to take lower doses of other drugs, such as steroids.
Are the injections painful to give?
Benlysta is given with a pre-filled pen just under the skin, similar to an insulin pen. Most people find it simple to use, though you might notice mild stinging or redness around the injection site.
What happens if my lupus gets worse during the study?
Your safety comes first. If you experience a lupus flare, the trial doctors will step in immediately to adjust your treatment and provide any extra care needed.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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