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SIRIUS-SLE Extension Study for Long-term Safety of Ianalumab in Systemic Lupus Erythematosus

This study is looking at the long-term safety of ianalumab in people with systemic lupus erythematosus (SLE), an autoimmune disease. You can join if you've already completed one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302). Participants will receive either ianalumab or a placebo (an inactive substance) monthly or quarterly. The main goal is to track any side effects or serious problems that happen during the study. This study plans to include 550 participants aged 12 to 100 years old. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 550 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for treatment-emergent adverse events and serious adverse events through study completion, up to approximately 91 months.

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NCT06133972

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

Recruiting
PHASE3Ages 12+InterventionalTreatment
Novartis Pharmaceuticals
~550 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:PlaceboIanalumab

At a glance

Recruiting sites
113 of 143 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of treatment-emergent Adverse events/Serious Adverse events
Measured over through study completion, up to approximately 91 months

Conditions

Systemic Lupus Erythematosus

Explore related trials

Systemic Lupus Erythematosus

Where it's being run

143 sites across 85 states
France5
Poland5
Taiwan5
Florida4
China4
Maharashtra4
Tokyo4
California3

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
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Eligibility criteria

Inclusion

Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \<18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.

Exclusion

Use of prohibited therapies.
Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
Plans for administration of live vaccines during the study period.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.

What this trial measures

  • Number of treatment-emergent Adverse events/Serious Adverse eventsthrough study completion, up to approximately 91 months

    Assessment of long-term safety and tolerability of ianalumab