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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 348
- 试验地点
- 51
- 主要终点
- Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death
研究概览
简要总结
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.
详细描述
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 In this extension study participants who achieve CRR or PRR status at Week 140 will be withdrawn from study treatment and will maintain the SoC medication as required.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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Use of prohibited therapies
- •Pregnant or nursing (lactating) women.
研究组 & 干预措施
Open-Label Ianalumab (cohort 2)
(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.
干预措施: Ianalumab (Drug)
Study Treatment Withdrawal (cohort 1)
(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.
结局指标
主要结局
Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death
时间窗: Between Week 144E1 and EOS (up to Week 456)
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
Cohort 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
时间窗: From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study
Number of participants with AEs and SAEs, including changes in vital signs and clinical laboratory measurements qualifying and reported as AEs.
次要结局
- Cohort 2: Incidence and titer of anti-ianalumab antibodies in serum (ADA assay)(from Week 144E1 up to Week 456)
- Cohort 2: Ianalumab concentration in serum using a validated ELISA(from Week 144E1 up to Week 456)
- Cohort 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)(From the start of treatment in the SIRIUS-LN core study to EOS (up to week 560) of the extension study)