Lupus Nephritis study: Ianalumab
Official 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)
ClinicalTrials.gov ID: NCT06711887
What this study is testing
What is Ianalumab?
Ianalumab is an investigational medicine, being studied as a potential treatment for lupus nephritis.
Also referred to as VAY736.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see how well patients do and how safe they stay after stopping the drug, and also track safety and effect of open‑label ianalumab 300 mg in those who keep taking it.
- Who it's for
- Adults with lupus nephritis who finished the earlier SIRIUS‑LN trial and either had a kidney response or did not meet response criteria.
- What's involved
- Participants will either stop the study drug or keep taking open‑label ianalumab 300 mg, and will have regular clinic visits, lab tests, and kidney assessments.
- Time commitment
- The extension can last up to 6 years with scheduled visits and tests throughout the period.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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 blinded or open label...
You likely can't join if
- Use of prohibited therapies
- Pregnant or nursing (lactating) women.
The study team makes the final eligibility decision.
Where it is enrolling
- Orchard Park, New York, United States
- Vitória, Espírito Santo, Brazil
- Salvador, Estado de Bahia, Brazil
- Belo Horizonte, Minas Gerais, Brazil
- Recife, Pernambuco, Brazil
- Santo André, São Paulo, Brazil
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Liuzhou, Guangxi, China
- Wuhan, Hubei, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Binzhou, Shandong, China
- Ningbo, Zhejiang, China
- Chongqing, China
- Guangzhou, China
- Shanghai, China
- Medellín, Antioquia, Colombia
- Barranquilla, Atlántico, Colombia
- Prague, Czechia
+ 24 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Orchard Park, New York, United States; Vitória, Espírito Santo, Brazil; Salvador, Estado de Bahia, Brazil; Belo Horizonte, Minas Gerais, Brazil; Recife, Pernambuco, Brazil; Santo André, São Paulo, Brazil and 38 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.