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Long-term safety evaluation of ianalumab for systemic lupus erythematosus

A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)

PHASE3 · Novartis · NCT06133972

This study is testing the long-term safety of a medication called ianalumab in people with systemic lupus erythematosus who have already tried other treatments.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment550 (estimated)
Ages12 Years to 100 Years
SexAll
SponsorNovartis (industry)
Drugs / interventionsianalumab
Locations127 sites (Anniston, Alabama and 126 other locations)
Trial IDNCT06133972 on ClinicalTrials.gov

What this trial studies

This extension study aims to assess the long-term safety and tolerability of ianalumab, administered either monthly or quarterly, in participants with systemic lupus erythematosus (SLE) who have previously completed core studies. Participants will receive either ianalumab or a placebo, and the study will focus on those with moderate-to-severe disease activity who are anti-nuclear antibody (ANA)-positive. The study will monitor participants for safety outcomes over an extended period following their initial treatment.

Who should consider this trial

Good fit: Ideal candidates are adolescents and adults with moderate-to-severe systemic lupus erythematosus who have completed prior SIRIUS-SLE core studies without treatment discontinuation.

Not a fit: Patients who have not participated in the prior SIRIUS-SLE core studies or those with active infections requiring significant treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety of ianalumab, potentially leading to improved treatment options for patients with systemic lupus erythematosus.

How similar studies have performed: Other studies evaluating similar therapies for systemic lupus erythematosus have shown promising results, indicating potential for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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.

Other protocol-defined inclusion/exclusion criteria may apply.

Where this trial is running

Anniston, Alabama and 126 other locations

+77 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Systemic Lupus Erythematosus, SLE, B cell depletion, SLEDAI-2K, BILAG-2004, SRI-4, ANA, ianalumab, VAY736

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.