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The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety
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 In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Treatment Withdrawal (cohort 1) | No Intervention | (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. | |
| Open-Label Ianalumab (cohort 2) | Experimental | (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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com |
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Circuit Clinical | Recruiting | Orchard Park | New York | 14127 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40465397 | Derived | 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. |
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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
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|
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) | 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 |
| Novartis Investigative Site | Recruiting | Vitória | Espírito Santo | 29055 450 | Brazil |
| Novartis Investigative Site | Recruiting | Salvador | Estado de Bahia | 40150 150 | Brazil |
| Novartis Investigative Site | Recruiting | Belo Horizonte | Minas Gerais | 30150-221 | Brazil |
| Novartis Investigative Site | Recruiting | Santo André | São Paulo | 09090-790 | Brazil |
| Novartis Investigative Site | Recruiting | Guangzhou | Guangdong | 510000 | China |
| Novartis Investigative Site | Active, not recruiting | Shantou | Guangdong | 515000 | China |
| Novartis Investigative Site | Recruiting | Shenzhen | Guangdong | 518037 | China |
| Novartis Investigative Site | Recruiting | Liuzhou | Guangxi | 545005 | China |
| Novartis Investigative Site | Recruiting | Wuhan | Hubei | 430060 | China |
| Novartis Investigative Site | Recruiting | Changchun | Jilin | 130041 | China |
| Novartis Investigative Site | Recruiting | Binzhou | Shandong | 256603 | China |
| Novartis Investigative Site | Recruiting | Beijing | 100034 | China |
| Novartis Investigative Site | Recruiting | Chongqing | 400038 | China |
| Novartis Investigative Site | Recruiting | Guangzhou | 510080 | China |
| Novartis Investigative Site | Recruiting | Guangzhou | 510280 | China |
| Novartis Investigative Site | Recruiting | Shanghai | 200080 | China |
| Novartis Investigative Site | Recruiting | Barranquilla | Atlántico | 080020 | Colombia |
| Novartis Investigative Site | Active, not recruiting | Olomouc | 779 00 | Czechia |
| Novartis Investigative Site | Recruiting | Prague | 128 00 | Czechia |
| Novartis Investigative Site | Recruiting | Guatemala City | 01010 | Guatemala |
| Novartis Investigative Site | Recruiting | Guatemala City | 01011 | Guatemala |
| Novartis Investigative Site | Recruiting | Tuenmen | 999077 | Hong Kong |
| Novartis Investigative Site | Recruiting | Budapest | H-1097 | Hungary |
| Novartis Investigative Site | Recruiting | Kuala Lumpur | Kuala Lumpur | 50586 | Malaysia |
| Novartis Investigative Site | Recruiting | Sibu | Sarawak | 96000 | Malaysia |
| Novartis Investigative Site | Recruiting | León | Guanajuato | 37160 | Mexico |
| Novartis Investigative Site | Recruiting | Oaxaca City | 68020 | Mexico |
| Novartis Investigative Site | Recruiting | Querétaro | 76070 | Mexico |
| Novartis Investigative Site | Recruiting | Bucharest | 022328 | Romania |
| Novartis Investigative Site | Recruiting | Singapore | 169608 | Singapore |
| Novartis Investigative Site | Recruiting | Singapore | S308433 | Singapore |
| Novartis Investigative Site | Recruiting | Suwon | Gyeonggi-do | 16499 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Recruiting | Seoul | 04763 | South Korea |
| Novartis Investigative Site | Recruiting | Barcelona | 08035 | Spain |
| Novartis Investigative Site | Recruiting | Taichung | 40447 | Taiwan |
| Novartis Investigative Site | Recruiting | Songkhla | Hat Yai | 90110 | Thailand |
| Novartis Investigative Site | Recruiting | Bangkok | 10330 | Thailand |
| Novartis Investigative Site | Recruiting | Bangkok | 10400 | Thailand |
| Novartis Investigative Site | Recruiting | Chiang Mai | 50200 | Thailand |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000656267 | ianalumab |
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