Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
NCT ID: NCT06711887
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
315 participants
INTERVENTIONAL
2025-05-19
2032-07-16
Brief Summary
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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.
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Detailed Description
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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 In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required.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 2 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Pregnant or nursing (lactating) women.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Liuchow, Guangxi, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Binzhou, Shandong, China
Novartis Investigative Site
Beijing, , China
Novartis Investigative Site
Guangzhou, , China
Novartis Investigative Site
Guangzhou, , China
Novartis Investigative Site
Barranquilla, Atlántico, Colombia
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
León, Guanajuato, Mexico
Novartis Investigative Site
Oaxaca City, , Mexico
Novartis Investigative Site
Querétaro, , Mexico
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Singapore, , Singapore
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Seoul, , South Korea
Novartis Investigative Site
Taichung, , Taiwan
Novartis Investigative Site
Songkhla, Hat Yai, Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Chiang Mai, , Thailand
Countries
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Central Contacts
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References
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Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.
Other Identifiers
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CVAY736K12301E1
Identifier Type: -
Identifier Source: org_study_id
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