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

August 21, 2026 updated by: Novartis Pharmaceuticals

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The SIRIUS-LN extension study is an up to 6-year open-label extension study for participants who have completed the treatment periods (blinded Treatment Period-1 and blinded Treatment Period-2) of the SIRIUS-LN core study on double-blind or open-label study treatment.

Investigators will use their clinical judgment to decide if it is beneficial for participants to continue with the extension study. In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required. These up to 6 additional years in the extension study will allow to measure sustained remission, flares and safety off-study treatment. However, in the event of renal flares during the extension study, these participants who withdraw study treatment will have the option to receive open-label ianalumab.

Study Type

Interventional

Enrollment (Estimated)

348

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055-450
        • Recruiting
        • Novartis Investigative Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40150-150
        • Recruiting
        • Novartis Investigative Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
        • Recruiting
        • Novartis Investigative Site
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50740-900
        • Recruiting
        • Novartis Investigative Site
    • São Paulo
      • Santo André, São Paulo, Brazil, 09090-790
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100034
        • Recruiting
        • Novartis Investigative Site
      • Chongqing, China, 400038
        • Recruiting
        • Novartis Investigative Site
      • Guangzhou, China, 510280
        • Recruiting
        • Novartis Investigative Site
      • Guangzhou, China, 510080
        • Recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200080
        • Recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Novartis Investigative Site
      • Shantou, Guangdong, China, 515000
        • Active, not recruiting
        • Novartis Investigative Site
      • Shenzhen, Guangdong, China, 518037
        • Recruiting
        • Novartis Investigative Site
    • Guangxi
      • Liuzhou, Guangxi, China, 545005
        • Recruiting
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130041
        • Recruiting
        • Novartis Investigative Site
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Recruiting
        • Novartis Investigative Site
  • Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Recruiting
        • Novartis Investigative Site
  • Czechia
      • Olomouc, Czechia, 779 00
        • Active, not recruiting
        • Novartis Investigative Site
      • Prague, Czechia, 128 00
        • Recruiting
        • Novartis Investigative Site
  • France
      • Grenoble, France, 38043
        • Recruiting
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01010
        • Recruiting
        • Novartis Investigative Site
    • Departamento de Guatemala
      • Guatemala City, Departamento de Guatemala, Guatemala, 01011
        • Recruiting
        • Novartis Investigative Site
    • Departamento de Quetzaltenango
      • Quetzaltenango, Departamento de Quetzaltenango, Guatemala, 09001
        • Recruiting
        • Novartis Investigative Site
  • Hong Kong
      • Tuenmen, Hong Kong, 999077
        • Recruiting
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1097
        • Recruiting
        • Novartis Investigative Site
  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Novartis Investigative Site
    • Sarawak
      • Sibu, Sarawak, Malaysia, 96000
        • Recruiting
        • Novartis Investigative Site
  • Mexico
      • Oaxaca City, Mexico, 68020
        • Recruiting
        • Novartis Investigative Site
      • Querétaro, Mexico, 76070
        • Recruiting
        • Novartis Investigative Site
    • Guanajuato
      • León, Guanajuato, Mexico, 37160
        • Recruiting
        • Novartis Investigative Site
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169608
        • Recruiting
        • Novartis Investigative Site
    • Singapore
      • Singapore, Singapore, Singapore, 308433
        • Recruiting
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 06591
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 04763
        • Recruiting
        • Novartis Investigative Site
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Recruiting
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Taichung, Taiwan, 40447
        • Recruiting
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Recruiting
        • Novartis Investigative Site
      • Bangkok, Thailand, 10330
        • Recruiting
        • Novartis Investigative Site
      • Bangkok, Thailand, 10700
        • Recruiting
        • Novartis Investigative Site
      • Chiang Mai, Thailand, 50200
        • Recruiting
        • Novartis Investigative Site
    • Hat Yai
      • Songkhla, Hat Yai, Thailand, 90110
        • Recruiting
        • Novartis Investigative Site
  • United States
    • New York
      • Orchard Park, New York, United States, 14127
  • Vietnam
    • VNM
      • Ho Chi Minh City, VNM, Vietnam, 700000
        • Recruiting
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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).
Other Names:
  • VAY736

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death
Time Frame: Between Week 144E1 and EOS (up to Week 456)
Cohort 1: To estimate the time to renal flare, increase in immunosuppressive medication, or death following study treatment withdrawal in participants who completed the SIRIUS-LN core study on double-blind treatment and achieved CRR or PRR at Week 140 of the core study
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
Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.
From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay)
Time Frame: from Week 144E1 up to Week 456
To assess immunogenicity to ianalumab in Cohort 2
from Week 144E1 up to Week 456
Cohort 2: Ianalumab concentration in serum using a validated ELISA
Time Frame: from Week 144E1 up to Week 456
To assess pharmacokinetics of ianalumab in Cohort 2
from Week 144E1 up to Week 456
Cohort 1: 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
Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.
From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2025

Primary Completion (Estimated)

August 1, 2035

Study Completion (Estimated)

August 1, 2035

Study Registration Dates

First Submitted

November 11, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAY736K12301E1
  • 2024-515280-60-00 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe