Follow-up study of ianalumab in people with lupus nephritis
Tests ianalumab, with or without stopping treatment, in adults with lupus nephritis.
Key facts
- Who runs it
- Novartis Pharmaceuticals
- Where
- Barranquilla and Medellín, ColombiaSee the 2 sitesAlso in 18 other countries, 51 sites
- Trial code
- NCT06711887
- EU 2024-515280-60-00
- U1111-1324-5224
- Registry title
- Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 348 people, planned
- Started
- 19 May 2025
- Expected to end
- 1 Aug 2035
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Ianalumab
- Record updated
- 9 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lupus nephritis who took part in the SIRIUS-LN core study and finished all study treatment up to Week 144.
- Age
- 18 to 100 years
- Sex
- All sexes can join.
- Disease stage
- Lupus nephritis. People who had a renal response at the end of the core study, and people who did not, can both take part.
- Earlier treatment
- Must have finished the whole treatment in the SIRIUS-LN core study, up to Week 144, on double-blind or open-label study treatment.
Main reasons for not taking part
- Use of prohibited therapies
- Pregnant women
- Nursing (breastfeeding) women
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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 take part
- Use of prohibited therapies
- Pregnant or nursing (lactating) women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in Colombia
Also in 18 other countries, 51 sites
- Barranquilla, AtlánticoHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
- MedellínHospital not named in the registryContact: Novartis PharmaceuticalsTaking people
About the trial
What the trial wants to find out
The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety
Read full original descriptionShow less
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.
The 2 groups in the trial
- Study Treatment Withdrawal (cohort 1)No study treatment, for comparison
(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)Treatment being tested
(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.
Treatment: Ianalumab
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Follow-up study of ianalumab in people with lupus nephritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06711887, who can take part
- Record updated
- 9 November 2026