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Long-term follow-up of ianalumab with or without stopping treatment for people with lupus nephritis

An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)

Phase 3 Interventional Novartis · NCT06711887

This 2-year extension will test whether continuing or stopping ianalumab keeps kidney disease under control and is safe for people with lupus nephritis who completed the core study.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment315 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsianalumab
Locations25 sites (Salvador, Estado de Bahia and 24 other locations)
Trial IDNCT06711887 on ClinicalTrials.gov

What this trial studies

Participants who completed the SIRIUS-LN core study are invited into a 2-year open-label extension to monitor long-term outcomes. Those who achieved complete or partial renal response at the end of the core study may stop study treatment and be followed on standard-of-care, while participants who did not respond or who were already on open-label treatment will receive open-label ianalumab 300 mg. Investigators will track sustained remission, renal flares, and safety over two years, with the option to restart open-label ianalumab if a renal flare occurs. The extension uses clinician judgement for continued participation and standard exclusion rules such as pregnancy and prohibited concomitant therapies.

Who should consider this trial

Good fit: People with lupus nephritis who completed the full SIRIUS-LN core treatment through Week 144, can give informed consent, and meet the study safety requirements are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, using prohibited therapies, or who did not complete the SIRIUS-LN core treatment are not eligible and are unlikely to benefit from this extension.

Why it matters

Potential benefit: If successful, this could show some patients can safely stay in remission after stopping ianalumab and clarify the longer-term safety and benefit of continued ianalumab for others.

How similar studies have performed: B-cell–targeting approaches, including other anti-BAFF agents, have shown benefit in lupus-related disease, but long-term withdrawal and extension data specifically for ianalumab remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Signed informed consent prior to participation in the extension study.
2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.

Exclusion Criteria:

1. Use of prohibited therapies
2. Pregnant or nursing (lactating) women.

Where this trial is running

Salvador, Estado de Bahia and 24 other locations

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 → Find more trials like this →
Conditions Lupus NephritisB cell depletionianalumabVAY736
Last reviewed 2026-06-10 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.