Active not recruitingPHASE3INTERVENTIONAL

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)

This research study, called SIRIUS-SLE 2, is looking at a new medicine called ianalumab for people living with Systemic Lupus Erythematosus (SLE), also known as lupus. The main goal is to find out if ianalumab is safe and effective when added to the usual treatments people already take for lupus. Participants will receive either ianalumab or a dummy drug (placebo) as a monthly injection under the skin. Researchers will then compare how both groups feel and how their lupus symptoms change. This is a Phase 3 study, meaning it’s a later stage of testing after earlier studies have shown promising results. It's open to adults and some teenagers aged 12 and over who have active lupus.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novartis Pharmaceuticals

Enrolment target

288

Start

21 Apr 2023

Estimated completion

09 Apr 2029

Systemic Lupus Erythematosus

What is this study about?

You've been invited to learn about a research study for people with Systemic Lupus Erythematosus (SLE), often just called lupus. Lupus is a long-term condition where your body's immune system mistakenly attacks healthy tissues, causing symptoms like joint pain, rashes, and tiredness. Researchers are always looking for new and better ways to manage lupus, and that's where this study comes in.

This study is testing a new medication called ianalumab. It’s given as a monthly injection under the skin, and the idea is to use it together with the treatments you might already be taking for your lupus. The main aim is to see if ianalumab can help reduce lupus symptoms and improve how you feel, compared to just continuing with your standard treatments alone. The study will also carefully check for any side effects, to make sure the treatment is safe.

This type of study is known as a "Phase 3" trial. This means that ianalumab has already been tested in smaller groups of people and shown some promising results, but now it needs to be tested in a larger group to confirm if it's truly effective and safe for many more people with lupus. Taking part could help improve treatments for lupus in the future, not just for you but for countless others.

Key takeaways

This study is testing a new drug called ianalumab for active lupus (SLE).
It aims to see if ianalumab is safe and helps control lupus symptoms.
Participants will receive monthly injections of either ianalumab or a placebo, alongside their usual lupus treatment.
It's a 'Phase 3' study, indicating it's a later stage of testing after promising earlier results.
Potential benefits include access to a new treatment; potential risks include side effects.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be able to take part in this study, you generally need to be at least 12 years old (though in some European countries, you need to be 18 or older). You must have a diagnosis of lupus that was made at least six months ago, using standard medical guidelines. Your lupus also needs to be active, meaning you still have symptoms, and doctors will use a scoring system to check this.

You should already be taking some form of treatment for your lupus, such as steroids, anti-malarial drugs, or other specific lupus medications (DMARDs).

There are also some reasons why you might not be able to join. For example, if you've already had ianalumab before, or if you've recently used certain other strong lupus medications, particularly those that target specific immune cells, you might not be eligible. This is to make sure the study can accurately measure the effects of ianalumab without interference from other treatments.

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 12 years old or older (18+ in some European countries)?
Have you been diagnosed with lupus for at least 6 months?
Do you currently have active lupus symptoms?
Are you currently taking medication for your lupus?
Have you avoided certain strong lupus medications recently (the study team can clarify which ones)?
Do you weigh at least 35 kg (about 5 and a half stone)?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive either the new drug, ianalumab, or a placebo (which looks like the study drug but contains no active medicine). Neither you nor your doctor would know which one you are getting. Both are given as injections under the skin once a month. You would continue to take your usual lupus medications alongside this.

You will have regular visits to the clinic for medical check-ups, blood tests, and to discuss any symptoms or side effects you might be having. These visits will help the doctors monitor your health and how your lupus is responding to the treatment. The entire study will last for a certain period, and this will be fully explained to you before you start. You will receive detailed information about the schedule of visits and assessments.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as gaining access to a new treatment before it's widely available and receiving close medical monitoring. However, there are also potential risks, including side effects from the study drug, which may be unknown or more severe than expected. There's also no guarantee that the study drug will help your condition, as you might receive the placebo. Your health and safety are paramount, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (93)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Pinnacle Research Group LLC
Verified postcode
Anniston, United States
Advanced Medical Research
Verified postcode
La Palma, United States
University of California LA
Verified postcode
Los Angeles, United States
Homestead Assoc In Research Inc
Verified postcode
Homestead, United States
IRIS Research and Development
Verified postcode
Plantation, United States
Emory University
Verified postcode
Atlanta, United States
Willow Rheumatology Wellness
Verified postcode
Willowbrook, United States
Bluegrass Community Research Inc
Verified postcode
Lexington, United States
Accurate Clinical Research
Verified postcode
Lake Charles, United States
UMC New Orleans
Verified postcode
New Orleans, United States
University Of Maryland
Verified postcode
Baltimore, United States
Ahmed Arif Medical Research Center
Verified postcode
Grand Blanc, United States

Common questions

What is lupus?

Lupus (Systemic Lupus Erythematosus) is a long-term condition where your body's immune system mistakenly attacks healthy tissues, causing inflammation and damage to organs like joints, skin, kidneys, and heart.

What is a placebo?

A placebo is a substance or treatment given to a group of people in a clinical trial that has no active drug. It helps researchers compare the effects of the actual drug against what happens when no active treatment is given.

Will I still take my regular lupus medicine?

Yes, if you join this study, you will continue to take your usual prescribed lupus medications alongside the study drug (ianalumab or placebo).

What does 'double-blind' mean?

Double-blind means that neither you (the participant) nor your study doctor will know whether you are receiving the active drug (ianalumab) or the placebo. This helps ensure fair and unbiased results.

How long will the study last?

The exact duration of your participation will be fully explained by the study team. It typically involves regular visits over several months or longer to assess the treatment's effects and safety.