A study to investigate the safety and pharmacological effect of a single intravenous infusion of GSK2857914 in male and female participants aged 18 to 75 with moderate to severe systemic lupus erythematosus
Researchers are conducting a study to learn more about a new medicine called GSK2857914. This medicine is being tested in people between 18 and 75 years old who have moderate to severe systemic lupus erythematosus, often just called lupus. Lupus is a long-term illness that can affect many parts of the body. The main goals of this study are to see if GSK2857914 is safe for people and to understand how it acts in the body after a single dose. The medicine will be given directly into a vein. This is an early stage study, meaning it's one of the first times this medicine is being tested in humans. It helps doctors decide if it's worth studying further.
At a glance
What is this study about?
This study is designed to explore a new potential treatment for systemic lupus erythematosus, a condition commonly known as lupus. Lupus is an autoimmune disease, which means the body's immune system, which normally fights off infections, mistakenly attacks healthy tissues. This can lead to inflammation and damage in various parts of the body, such as the joints, skin, kidneys, heart, and lungs. Because lupus can affect people differently, finding new treatments is very important.
The specific medicine being tested in this study is called GSK2857914. It's an experimental drug, meaning it's not yet approved for general use. The researchers want to find out two key things: first, if this medicine is safe for people with lupus, and second, how it behaves in the body after it's given. Learning how a medicine acts, for example, how long it stays in the body or how it’s processed, helps doctors understand its potential effects.
This is a 'Phase I' study, which is an early step in testing new medicines. In this phase, a small group of people usually participate, and the main focus is on safety and understanding how the medicine works at a basic level, rather than on whether it cures the disease. Participants in this study will receive one dose of GSK2857914 directly into a vein.
Key takeaways
- Tests a new medicine (GSK2857914) for lupus.
- Focuses on safety and how the medicine works in the body.
- For adults aged 18-75 with moderate to severe lupus.
- Involves a single dose given into a vein.
- Participation includes screening, the dose, and follow-up visits.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, participants must be between 18 and 75 years old. The study includes both men and women.
You must have been diagnosed by a doctor with moderate to severe systemic lupus erythematosus. This means your lupus is active and affecting your body in a way that requires treatment.
There will be other health requirements and tests to make sure that taking part in the study is right and safe for you. The study team will review your medical history and conduct examinations to determine if you meet all the criteria.
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 between 18 and 75 years old?
- Do you have a diagnosis of moderate to severe lupus?
- Are you able to attend all required study visits?
- Are you willing to receive a single intravenous infusion?
- Are you able to understand and agree to the study procedures?
What does participation involve?
If you decide to join this study, you would first go through a screening process to make sure you meet all the requirements. This might involve physical exams, blood tests, and reviewing your medical history. If you are eligible, you will receive a single dose of the study medicine, GSK2857914, given directly into a vein (intravenously).
After receiving the medicine, you will have several follow-up visits with the study team. These visits will involve various assessments, such as blood tests, urine tests, and check-ups, to monitor your health, see how your body reacts to the medicine, and check for any side effects. The exact number of visits and the total duration of your participation will be explained in detail by the study team, but generally, early phase studies involve close monitoring over several weeks or months after the dose.
Potential risks and benefits
Locations (2)
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Common questions
What is systemic lupus erythematosus (lupus)?
Lupus is a long-term illness where your body's immune system mistakenly attacks healthy tissues, leading to inflammation and damage in different body parts.
What is GSK2857914?
It's an experimental medicine being tested for lupus. It's not approved for general use yet, and this study is looking at its safety and how it works.
How will the medicine be given?
The medicine will be given as a single dose directly into a vein in your arm, similar to a drip.
Why is this study being done?
This study aims to understand if the new medicine, GSK2857914, is safe for people and how it acts in the body, which are important first steps in developing new treatments.
Will this medicine cure my lupus?
This early stage study is mainly focused on safety and understanding the drug's effects, not on curing the disease. We can't say if it will cure lupus at this stage.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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