Recruiting
Phase 3

Ianalumab

Sponsor:

Novartis Pharmaceuticals

Code:

NCT06711887

Conditions

Lupus Nephritis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ianalumab

Study Details

Brief summary:

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.

Conditions

Lupus Nephritis

Study ID

NCT06711887

Start date

May 19, 2025

Status verified date

Aug, 2026

Completion date

Aug 1, 2035

Anticipated

Primary completion date

Aug 1, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not 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.

Study Design

Enrollment

348 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Ianalumab

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

Primary outcome measure

  • Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death [ Time Frame: Between Week 144E1 and EOS (up to Week 456) ]
  • Cohort 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111novartis.email@novartis.com

Locations

Circuit Clinical

Recruiting

Orchard Park, New York, United States, 14127

Contacts

Gabriella Demelo

gdemelo@circuitclinical.com

Principal Investigator:

Isha Gupta

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Lupus Nephritis (LN)
  • B cell depletion
  • ianalumab
  • VAY736

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-24.