Image

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).

We're studying Ianalumab's long-term safety for lupus (SLE) patients.

Recruiting
12 years and older
All
Phase 3

Systemic Lupus Erythematosus (SLE) is an autoimmune disease where the body attacks its own cells. This study checks if a medicine called ianalumab is safe to use for a long time in people who have moderate to severe SLE. Participants need to have finished one of the earlier SLE studies to join. The study lasts up to 7 years and is divided into three parts:

  • First, a 3-year period where participants will receive either the medicine or a placebo (a harmless pill) without knowing which one it is.
  • Second, a 2-year period where the safety of stopping the medicine is checked. If needed, participants can take ianalumab openly.
  • Finally, up to 2 years of monitoring to ensure safety.

To join, participants must have completed one of the earlier studies and be expected to benefit from the treatment. They shouldn't use certain therapies, have active infections, or receive live vaccines during the study. Pregnant or nursing women cannot participate. It's important for participants to agree and sign forms before starting.

Study details
    Systemic Lupus Erythematosus

NCT06133972

Novartis Pharmaceuticals

11 October 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Race*
Are you a healthy volunteer
Ethnicity*
Are you a healthy volunteer
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.