Not knowing when your next systemic lupus erythematosus (SLE) flare-up will happen can seriously affect your life. Lupus is a debilitating autoimmune disease that can damage multiple organs and has a significant impact on physical and mental health.

Current treatment options for SLE vary, depending on a person’s symptoms.1 However, available treatments may cause side effects and have limited ability to reduce flares.

Therefore, more treatment options are needed. That’s why we’re conducting the SIRIUS-SLE clinical trials – we want to see if an investigational drug can potentially reduce symptoms of SLE.

See if you’re eligible (link is external)

What will taking part involve?

If you choose to take part in one of the SIRIUS-SLE trials, some assessments will be carried out to make sure that the trial is right for you.

The total amount of time that you’ll spend in the study will be for a maximum of 40 months (just over 3 years), as 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 study doctor will explain this in more detail, should you take part. You’ll continue to receive your standard of care regardless of which study or treatment group you join.

We’ll continue to monitor your health after you stop taking your assigned study treatment.

You may also have the opportunity to participate in a trial extension before going into the follow-up period if you and your doctor both agree.

See if you’re eligible(link is external)

How is the investigational drug thought to work?

  • B cells are a type of white blood cell and are central to the immune system. They produce antibodies that circulate around the body, seeking and attacking foreign molecules like viruses and bacteria.
  • However, in people with autoimmune diseases, these antibodies bind to the body instead, causing the damage and inflammation seen in conditions such as SLE.
  • B-cell activating factor (BAFF) is a protein that supports B-cell activity. Although the specific cause of SLE is still not known, it’s thought that people with SLE have increased B-cell activity together with high levels of BAFF.
  • The investigational drug in the SIRIUS-SLE trial is thought to have a dual action – it may deplete B cells while also potentially blocking BAFF activity. In this way, it’s hoped that the investigational drug will limit the damaging effects of B-cell activity that could be causing the symptoms of SLE.

Who can take part?

Trial eligibility Yes checkbox in blue square icon


To take part in the SIRIUS-SLE trial, in addition to other criteria, potential participants must:

  • Be aged 12 years or older
  • Have been diagnosed with SLE for at least 6 months
  • Weigh at least 77 lbs (35kg)
Trial Eligibility No cross mark in blue square icon


In addition to other criteria, potential participants must not:

  • Be pregnant or nursing (or planning to become pregnant or nurse during the trial)
  • Have non-lupus conditions such as asthma, gout, or urticaria, requiring treatment with corticosteroids
  • Have severe kidney disease

Potential participants need to have lupus-related disease activity at screening.

For full eligibility criteria of SIRIUS-SLE-1, please visit: Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1)(link is external)

For full eligibility criteria of SIRIUS-SLE-2, please visit: Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)(link is external)

Participation in clinical trials is completely voluntary.

See if you’re eligible (link is external)

How will each participant’s health be monitored?

Participants will need to visit the study clinic regularly. This is so that we can administer their assigned trial treatment and monitor their general health and SLE with assessments such as:

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Physical examinations

Blood tests, blue syringe icon

Blood samples

Urine tests, blue test tube icon

Urine samples

Skin prick testing, blue microscope icon

SLE assessments

Questionnaires, blue writing on sheet icon

Questionnaires

Vital signs, blue heart icon

Vital signs

See if you’re eligible (link is external)

About SLE

  • SLE is the most common type of lupus.2 Lupus is an autoimmune disease – a disorder in which antibodies produced by B cells bind to the body instead. This can affect many parts of the body and multiple organ systems, causing inflammation and damage to the affected organs.
  • Symptoms can range from mild to severe in various organ systems. A malar rash, also called a butterfly rash, is a common symptom of SLE.
  • Like other autoimmune diseases, we’re not sure what causes SLE.
Smiling female doctor reassuring a smiling male clinical trial participant by patting him on the shoulder in a supportive manner.

What is a clinical trial?

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 us improve medicine all around the world. They help us discover:

  • Alternative ways to diagnose conditions
  • Alternative ways to treat conditions
  • Alternative ways to track the progress of conditions

Different types of clinical trials

Clinical trials help us answer scientific questions, but different types of trials help us do this in different ways. For example:

Female doctor taking the blood pressure of a male clinical trial participant.

Interventional trials

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-SLE trials are interventional.

A female healthcare professional sits at a computer as she and two male healthcare professionals review the information on a screen.

Observational trials

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.

Find out if you could take part(link is external)

Frequently asked questions

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.

About the SIRIUS-SLE clinical trials

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 56 weeks. You’ll receive two study treatment injections at the same time and the injection sites on your body will be rotated between visits. The study team will make sure you’re as comfortable as possible during your study treatment administration.

Benefits to taking part in this clinical trial include frequent health assessments. Risks to taking part in this clinical trial include:

  • The investigational drug may have unknown side effects
  • The investigational drug may not work for you

Your SLE may stay the same or get worse.

At every stage of the trial, your health and well-being are the top priority. Therefore, if you have a flare (worsening of your disease) during the trial, the study 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 study team as soon as possible. They can then reschedule your appointment.

You’ll be randomly assigned to receive either the investigational drug (monthly or quarterly) or placebo. Your study doctor will explain this in more detail, should you take part.

Both trials are ‘double-blind’. This means that neither you nor the study team at the clinic will know whether you’ve been assigned 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. 

Find out if you can take part(link is external)
Other questions about clinical trials

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 study placebo will be given on top of your regular treatment to SLE. 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 approved 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:

  • The investigational drug may have unknown side effects
  • The investigational drug may not work for you

Many clinical trials are ‘randomized’ and ‘double-blind’. Randomized means a participant will be allocated to a 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 study coordinator at the clinical trial site will be able to provide you with more information.

References:

  1. Fanouriakis A, Tziolos N, Bertsias G, et al (2021) Update on the diagnosis and management of systemic lupus erythematosus. Ann Rheum Dis; 80(1): 14-25.
  2. Maidhof, W., & Hilas, O. (2012). Lupus: an overview of the disease and management options. Pharmacy and Therapeutics; 37(4): 240.