Lupus NephritisPhase 3SIRIUS-LN extNCT06711887
Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
A Phase 3 study testing Ianalumab in people with Lupus Nephritis, run by Novartis Pharmaceuticals at 51 sites in 18 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Ianalumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 51 sitesin 18 countries
- Study dates
- 19 May 2025to 1 Aug 2035
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to participation in the extension study.
- 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.
Who cannot join
- Use of prohibited therapies
- Pregnant or nursing (lactating) women.
Trial locations and contacts
51 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
51 sites in 18 countries
China15 sites, 14 recruiting
- Recruiting
Novartis Investigative Site
Beijing, 100034
- Recruiting
Novartis Investigative Site
Binzhou, Shandong, 256603
- Recruiting
Novartis Investigative Site
Changchun, Jilin, 130041
- Recruiting
Novartis Investigative Site
Chongqing, 400038
- Recruiting
Novartis Investigative Site
Guangzhou, Guangdong, 510000
- Recruiting
Novartis Investigative Site
Guangzhou, 510080
- Recruiting
Novartis Investigative Site
Guangzhou, 510280
- Recruiting
Novartis Investigative Site
Liuzhou, Guangxi, 545005
- Recruiting
Novartis Investigative Site
Ningbo, Zhejiang, 315016
- Recruiting
Novartis Investigative Site
Shanghai, 200040
- Recruiting
Novartis Investigative Site
Shanghai, 200080
- Active, not recruiting
Novartis Investigative Site
Shantou, Guangdong, 515000
- Recruiting
Novartis Investigative Site
Shenyang, Liaoning, 110004
- Recruiting
Novartis Investigative Site
Shenzhen, Guangdong, 518037
- Recruiting
Novartis Investigative Site
Wuhan, Hubei, 430060
Brazil5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-221
- Recruiting
Novartis Investigative Site
Recife, Pernambuco, 50740-900
- Recruiting
Novartis Investigative Site
Salvador, Estado de Bahia, 40150-150
- Recruiting
Novartis Investigative Site
Santo André, São Paulo, 09090-790
- Recruiting
Novartis Investigative Site
Vitória, Espírito Santo, 29055-450
Thailand5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Bangkok, 10330
- Recruiting
Novartis Investigative Site
Bangkok, 10400
- Recruiting
Novartis Investigative Site
Bangkok, 10700
- Recruiting
Novartis Investigative Site
Chiang Mai, 50200
- Recruiting
Novartis Investigative Site
Songkhla, Hat Yai, 90110
South Korea4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Seoul, 03722
- Recruiting
Novartis Investigative Site
Seoul, 04763
- Recruiting
Novartis Investigative Site
Seoul, 06591
- Recruiting
Novartis Investigative Site
Suwon, Gyeonggi-do, 16499
Guatemala3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01011
- Recruiting
Novartis Investigative Site
Guatemala City, 01010
- Recruiting
Novartis Investigative Site
Quetzaltenango, Departamento de Quetzaltenango, 09001
Mexico3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
León, Guanajuato, 37160
- Recruiting
Novartis Investigative Site
Oaxaca City, 68020
- Recruiting
Novartis Investigative Site
Querétaro, 76070
Colombia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Barranquilla, Atlántico, 080020
- Recruiting
Novartis Investigative Site
Medellín, Antioquia, 050001
Czechia2 sites, 1 recruiting
- Active, not recruiting
Novartis Investigative Site
Olomouc, 779 00
- Recruiting
Novartis Investigative Site
Prague, 128 00
Malaysia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Kuala Lumpur, Kuala Lumpur, 50586
- Recruiting
Novartis Investigative Site
Sibu, Sarawak, 96000
Singapore2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Singapore, Singapore, 308433
- Recruiting
Novartis Investigative Site
Singapore, 169608
United States1 site, 1 recruiting
- Recruiting
Circuit Clinical
Orchard Park, New York, 14127
Gabriella Demelo, gdemelo@circuitclinical.com
Isha Gupta
France1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Grenoble, 38043
Hong Kong1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Tuenmen, 999077
Hungary1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Budapest, 1097
Romania1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Bucharest, 022328
Spain1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Barcelona, 08035
Taiwan1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Taichung, 40447
Vietnam1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Ho Chi Minh City, VNM, 700000
About this study
Official title: 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
- 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
- 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.
Read the 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.
- Conditions
- Lupus Nephritis
- Being tested
- Ianalumab
- Keywords
- Lupus Nephritis (LN), B cell depletion, ianalumab, VAY736
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IanalumabDrug
Also called VAY736
Ianalumab (VAY736) is a human monoclonal antibody (mAb) of the IgG1/κ-class, directed against B cells and binding to BAFF receptor (BAFF-R).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ianalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study
Secondary outcomes (3)
Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay)
To assess immunogenicity to ianalumab in Cohort 2
Measured: from Week 144E1 up to Week 456
Cohort 2: Ianalumab concentration in serum using a validated ELISA
To assess pharmacokinetics of ianalumab in Cohort 2
Measured: 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.
Measured: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start19 May 2025
- Primary completion1 Aug 2035 (estimated)
- Study completion1 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711887
- Sponsor's protocol ID
- CVAY736K12301E1
- Other IDs
- 2024-515280-60-00
- Acronym
- SIRIUS-LN ext
- Status last verified
- Oct 2026
- First submitted
- 11 Nov 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
- Expanded access
- Available
Publications
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.
PubMed 40465397