A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients with Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)
This research study is investigating a new medication called telitacicept for adults who have a type of lupus called systemic lupus erythematosus (SLE) that is moderate to severe. The study aims to find out if telitacicept is effective in reducing lupus symptoms and if it is safe for patients to use. Participants will be given either the new medicine (telitacicept) or a placebo, which looks like the medicine but has no active ingredients. This helps researchers understand the true effects of the new treatment. The study will last for about a year, with regular checks on how patients are feeling and how their lupus is responding. It will also look at whether people can reduce their steroid medication while on the study drug.
At a glance
What is this study about?
This study is looking into a new treatment called telitacicept for adults who have systemic lupus erythematosus (SLE), specifically when their lupus is causing moderate to severe symptoms. Lupus is a long-term condition that can affect many parts of the body, and researchers are always working to find better ways to manage it.
The main goal of this particular study is to see how well telitacicept works compared to a 'dummy' treatment, called a placebo. A placebo looks exactly like the real medicine but doesn't contain any active drug. This is important because it helps the medical team understand if any improvements are genuinely due to the telitacicept or if they might happen anyway. The study will also carefully check for any side effects to make sure the new medicine is safe for patients.
The study will follow participants for about a year, regularly checking their lupus symptoms and overall health. Scientists will be looking to see if patients taking telitacicept have fewer lupus symptoms and if their condition improves compared to those taking the placebo. They'll also be seeing if patients can reduce their dose of steroid medications, which can have their own side effects, while on the study treatment.
Key takeaways
- The study is testing a new medicine called telitacicept for moderate to severe lupus.
- It will compare telitacicept to a 'dummy' treatment (placebo) to see how well it works and if it's safe.
- Participants will receive injections and have regular check-ups for about one year.
- The study aims to see if telitacicept can reduce lupus symptoms and allow patients to lower steroid doses.
- It's a 'double-blind' study, meaning neither you nor your doctor will know if you're getting the active drug or placebo.
Who may be eligible?
This study is open to adults aged 18 and older. Both men and women are welcome to take part. The most important requirement is that you must have systemic lupus erythematosus (SLE) that your doctors consider to be moderate to severe.
There will be other detailed medical checks to make sure the study treatment is safe and appropriate for you. For example, the medical team will need to review your current health, past medical history, and any other medications you are taking.
These checks are important to ensure that the study is as safe as possible for everyone involved and that the results are clear and reliable. Your study doctor will discuss all the specific criteria with you to see if you are a good fit for this research.
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?
- Do you have systemic lupus erythematosus (SLE)?
- Is your lupus considered moderate to severe by your doctor?
- Are you able to attend regular clinic appointments for about a year?
What does participation involve?
If you decide to take part in this study, you will be given either the study medicine, telitacicept, or a placebo (a dummy injection). You won't know which one you are receiving, and neither will your study doctor – this is called 'double-blind' and helps ensure fair results. The medicine will be given as an injection under the skin, likely using a pre-filled syringe.
You will have regular visits to the clinic for about a year. During these visits, the study team will carry out various checks. This will include physical examinations, blood tests, and discussions about how you are feeling and any changes in your lupus symptoms or other health conditions. They will also collect information on any changes to your other medications, especially steroid doses.
The total duration of your active participation in the study, including receiving the medication and regular check-ups, will be about 52 weeks (one year). After this, there might be a follow-up period to monitor your health further.
Potential risks and benefits
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Common questions
What is systemic lupus erythematosus (SLE)?
SLE is a long-term (chronic) autoimmune disease where your body's immune system mistakenly attacks healthy tissues, leading to inflammation in various parts of the body.
What is a 'placebo'?
A placebo is a substance that looks exactly like the real medicine but contains no active ingredients. It is used in studies to compare the new medicine's effects against a non-active treatment.
What does 'double-blind' mean?
Double-blind means that neither you nor your study doctor will know whether you are receiving the real medicine (telitacicept) or the placebo. This helps prevent bias in the study results.
How will I take the study medicine?
The study medicine (telitacicept or placebo) will be given as an injection under the skin, using a pre-filled syringe. You'll be shown how to do this or it will be done for you by a healthcare professional.
How long will I be in the study?
Your active participation in the study, including receiving treatment and attending appointments, will last for about 52 weeks (one year).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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