A Multi-Center, Open-Label Trial to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Subcutaneously Administered Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Participants with Systemic Lupus Erythematosus (SLE)
This study, called a Phase II trial, is investigating a medicine named Benlysta for children and young people with Systemic Lupus Erythematosus (SLE), often just called lupus. Lupus is a long-term condition that can affect many parts of the body. The main goals of this study are to understand how the body processes Benlysta when given as an injection under the skin, and to check for any side effects. Researchers will be looking at how much of the medicine is in the body at different times and how safe it is over nearly a year. This research aims to understand more about using Benlysta in younger patients.
At a glance
What is this study about?
This research is a 'Phase II' clinical trial, which means it's an early-stage study designed to gather more information about a new or existing treatment. In this case, the study is looking at a medicine called Benlysta (its scientific name is belimumab) for children and young people who have Systemic Lupus Erythematosus (SLE), commonly known as lupus.
Lupus is a chronic condition where the body's immune system mistakenly attacks its own tissues. This can cause inflammation and damage to joints, skin, kidneys, and other organs. Benlysta is already approved for adults with lupus, and this study aims to see how it works and is handled by the body in younger patients when given as an injection under the skin.
The main things the researchers want to find out are how the body absorbs, uses, and gets rid of the medicine (this is called pharmacokinetics), and to check for any side effects or problems that might occur over time. They will also look at how the medicine might affect certain markers in the blood related to lupus. By understanding these things, doctors can decide if this treatment could eventually be a good option for children and young people with lupus.
Key takeaways
- This is an early study (Phase II) looking at Benlysta for children and young people with lupus.
- The main goals are to understand how the body handles Benlysta and to check its safety over a year.
- Benlysta is given as an injection under the skin using a pre-filled pen.
- Participants will have regular clinic visits for blood tests and monitoring.
- The study aims to gather important information for future treatment options in younger patients with lupus.
Who may be eligible?
To join this study, participants can be of any age range, meaning both younger children and older teenagers with lupus might be considered. Both boys and girls are welcome to take part in this research.
More specific details about things like the type or severity of your lupus, any other medicines you're taking, or other health conditions you might have, would be carefully reviewed by the study doctors. These details help ensure the study is safe for you and that the results are clear.
If you're interested, the best step is to talk to your doctor or the study team. They will go through a full list of criteria to see if this study is suitable for you.
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.
- Do I have Systemic Lupus Erythematosus (SLE)?
- Am I a child or young person (any age)?
- Am I able to visit the clinic regularly for check-ups and injections?
- Am I currently receiving standard treatment for my lupus?
- Am I willing to have blood tests taken throughout the study?
What does participation involve?
If you decide to take part in this study, you would receive the study medicine, Benlysta, as an injection under your skin, in addition to your usual lupus treatments. This medicine is given using a special pre-filled pen.
Throughout the study, you'll have regular visits to the clinic. During these visits, doctors and nurses will take blood samples to see how your body is handling the medicine and to check for any changes in your lupus. They will also monitor you closely for any side effects or problems.
The study will last for approximately 52 weeks, which is about a year. During this time, the team will ensure you are supported and well-informed about your progress.
Potential risks and benefits
Locations (2)
- —UnverifiedSpain
- —UnverifiedGermany
Common questions
What is lupus?
Lupus, or Systemic Lupus Erythematosus (SLE), is a long-term condition where your body's immune system mistakenly attacks its own healthy tissues, causing inflammation and damage.
What is Benlysta?
Benlysta (belimumab) is a medicine that works by targeting specific cells in your immune system that are overactive in lupus. It helps to calm down the immune system.
What does 'pharmacokinetics' mean?
In simple terms, pharmacokinetics is about how your body handles a medicine – how it gets absorbed, distributed, processed, and eventually leaves your body.
What is a Phase II trial?
A Phase II trial is an early stage of research that aims to better understand how a new treatment works, if it's safe, and what dose might be best, often in a small group of patients.
Will I still take my regular lupus medicines?
Yes, in this study, Benlysta would be given in addition to your standard ongoing treatment for lupus, meaning you would continue your usual medicines.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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