Lupus nephritis (LN) is a serious complication of systemic lupus erythematosus (SLE) characterized by inflammation of the kidneys.1 Living with LN can be very challenging, with available treatments often having side effects2 and limited ability to adequately prevent disease flare.3
Therefore, more treatment options are needed. That’s why we’re conducting the SIRIUS-LN clinical trial to see if an investigational drug is safe and effective.
If you are eligible and choose to take part in the SIRIUS-LN trial, some assessments will be carried out to make sure that the trial is right for you.
You’ll spend a total of up to 5 years in the trial. The duration of each period of the trial is detailed below.
We’ll carry out some assessments to make sure the study is right for you.
You’ll receive either the investigational drug and/or a placebo every 4 weeks. Your trial doctor will explain this in more detail, should you take part. You’ll continue to receive your standard of care (a treatment generally recommended by medical experts) regardless of whether you receive the investigational drug or placebo.
We’ll continue to monitor your health after you stop taking your assigned trial treatment.
To take part in the SIRIUS-LN trial, in addition to other criteria, potential participants must:
In addition to other criteria, potential participants must not:
For the full eligibility criteria of SIRIUS-LN, please visit:
Participation in clinical trials is completely voluntary and you are free to leave at any time without any change to your usual healthcare.
Participants will need to visit the trial clinic regularly. This is so that we can administer their assigned trial treatment and monitor their general health and LN with assessments such as:
Every year, hundreds of thousands of people take part in clinical trials (also known as clinical studies). These are carefully controlled scientific investigations that help to improve the practice of medicine all around the world. They help us discover:
Clinical trials help us answer scientific questions, but different types of trials help us do this in different ways. For example:
Participants are asked to change their care somehow. For example, they may be asked to take an investigational drug or change their diet. The SIRIUS- LN trial is interventional.
Participants are asked to continue their usual healthcare regimen while healthcare professionals monitor their condition. For example, the level of a certain substance (e.g., an antibody) in the blood could be monitored.
We’ve compiled answers to some of the most common questions about clinical trials, as well as any specific questions related to this particular clinical trial.
You’ll be randomly assigned to receive either the investigational drug or placebo. Your trial doctor will explain this in more detail, should you take part.
This trial is ‘double-blind’. This means that neither you nor the trial team at the clinic will know whether you’ll receive the investigational drug or the placebo. Using a placebo helps us to be sure any changes seen are due to the investigational drug alone and not some other factor.
Both the investigational drug and placebo will be given as subcutaneous (under the skin) injections into either your arm, abdomen or thigh, every 4 weeks for up to 144 weeks (33 months). You’ll receive two injections at every visit and the injection sites on your body will be rotated. The trial team will make sure you’re as comfortable as possible during administration of the investigational drug.
Benefits to taking part in this clinical trial include frequent health assessments.
Risks to taking part in this clinical trial include:
Your LN may stay the same, not respond, or get worse.
At every stage of the trial, your health and well-being are the top priority. Therefore, if you have a flare during the trial, the trial doctor will take immediate action to ensure you receive appropriate medical care and treatment.
It’s really important that you stick to the visit schedule so that we can closely monitor your health and give you your trial treatment.
However, we do understand that plans can suddenly change. Therefore, if you can’t make a visit, or you miss one, please contact the trial team as soon as possible. They can then reschedule your appointment.
A placebo is a ‘dummy drug’ that looks just like the investigational drug and is given the same way; however, it contains no active medicine. Using a placebo helps us to understand if any changes seen are due to the investigational drug and not some other factor. But that doesn’t mean people in the placebo group receive no care. In this trial placebo will be given on top of your standard of care LN treatment. The health of every participant will be closely monitored throughout their participation in a trial.
Participation in clinical trials is voluntary. This means that you are under no obligation to take part and you are free to leave at any time without penalty. However, we would encourage all potential participants to stay in a trial for its duration, if possible.
No. You do not need medical insurance to take part in this clinical trial.
Every clinical trial is designed to be as safe as possible for participants and must be reviewed by regulatory boards (such as the US Food and Drug Administration) before it can begin. It is the job of these boards to protect the safety and rights of a trial’s participants. They do this by reviewing the trial’s protocol. A protocol is a plan that explains the need for the trial, what participants will need to do, and how their health will be monitored.
Risks to taking part in this clinical trial include:
Before a person can be enrolled into a clinical trial, they must meet eligibility criteria specific to that trial.
Many clinical trials are ‘randomized’ and ‘double-blind’. Randomized means a participant will be allocated to a study treatment group by chance, like the flip of a coin. Double-blind means that neither the participant nor the trial team will know which group the participant is in until after the trial is complete. This is to ensure that any effects seen are due to the investigational drug alone. Some clinical trials offer ‘open-label’ treatment. This means participants and the trial doctor will know that they are receiving the investigational drug. If you pass the pre-screener, the trial coordinator at the clinical trial site will be able to provide you with more information.
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