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

Part of paid clinical trials in Orchard Park, New York.

Sponsor: Novartis Pharmaceuticals
Study ID: NCT06711887
Phase: PHASE3
Status: Recruiting

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Conditions

Lupus Nephritis

Eligibility Criteria

Sex: ALL
Age: 18 Years - 100 Years
Healthy Volunteers: Not accepted

Interventions

Ianalumab — DRUG
Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).

Study Details

The purpose of this up to 6-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.

Key Dates

First listed: Dec 2, 2024
Start date: May 19, 2025
Status verified: Jul 2026
Primary completion: Aug 1, 2035
Completion: Aug 1, 2035

Study Design

Enrollment: 348 participants (estimated)
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

No Intervention: Study Treatment Withdrawal (cohort 1)
(Cohort 1): Study Treatment-Withdrawal group. Participants who received blinded study treatment in the core study and achieve CRR or PRR at Week 140 in the core study will enter the extension study and discontinue study treatment while maintaining standard of care (SoC) medication, as required. If renal flare criteria are met, participants will be eligible to receive open-label ianalumab.
Experimental: Open-Label Ianalumab (cohort 2)
(Cohort 2): Open-Label Ianalumab group: Participants who received blinded study treatment throughout the core study and did not achieve CRR or PRR at Week 140 of the core study, or who had switched to open-label ianalumab during the core study, will be eligible or will continue to receive open-label ianalumab in the extension study.