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

Phase 3 study checking long-term safety of Ianalumab for lupus patients.

Recruiting
12 years and older
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Phase 3

This study aims to check the long-term safety of a drug called ianalumab for people with systemic lupus erythematosus (SLE). SLE is a disease where the immune system attacks healthy tissues by mistake. This study is for people who finished a previous part of the research called SIRIUS-SLE. In this extension study, participants will continue taking ianalumab either once a month or less often, or a placebo (a fake treatment), to see how well they handle it over time.

  • Participants must have completed a previous study phase.
  • They must not be on certain restricted treatments and should not have any major infections or plan to get live vaccines.
  • Pregnant or nursing women can't join, and participants should use effective birth control if they're able to have children.

Before joining, participants need to sign a consent form (or have a parent/legal guardian do so if under 18). This study is important to ensure that ianalumab can be safely used for treating SLE over a long period.

Study details
    Systemic Lupus Erythematosus

NCT06133972

Novartis Pharmaceuticals

18 April 2026

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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.
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