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Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)

RECRUITINGPhase 3Sponsored by Novartis Pharmaceuticals
Actively Recruiting
PhasePhase 3
SponsorNovartis Pharmaceuticals
Started2025-05-19
Est. completion2030-07-16
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06711887

Summary

The purpose of this 2-year extension study is the evaluation of the efficacy and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \[CRR\] or partial renal response \[PRR\]) on double-blind treatment at the end of the SIRIUS-LN core study, and 2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.

Eligibility

Age: 18 Years – 100 YearsHealthy volunteers accepted
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.

Conditions2

LupusLupus Nephritis

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