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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)

NCT06711887 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2026-03-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-19
Primary Completion
2030-07-16
Completion
2032-07-16
FDA Drug
Yes

Countries

  • Brazil
  • China
  • Colombia
  • Hungary
  • Mexico
  • Romania
  • Singapore
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06711887 on ClinicalTrials.gov