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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)
EU CTIS ID: 2024-515280-60-00
What this study is testing
Cohort1: To estimate the incidence of renal flare, escalation of 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 Cohort2: To assess the safety and tolerability of ianalumab for participants 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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 double-blind or open label study treatment.
You likely can't join if
- Use of prohibited therapies as defined in Section 6.5.2 of the protocol.
- Pregnant or nursing (lactating) women
The study team makes the final eligibility decision.
Where it's taking place
- Guatemala
- Hong Kong
- Thailand
- Vietnam
- Taiwan
- Malaysia
- India
- Chile
- China
- Colombia
- Korea, Republic of
- United Kingdom
- United States
- Argentina
- Singapore
- Brazil
- Canada
- Mexico
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guatemala; Hong Kong; Thailand; Vietnam; Taiwan; Malaysia and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.