A Randomized, Double-blind, Placebo-controlled Extension Study to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 159
- 主要终点
- Number of treatment-emergent Adverse events/Serious Adverse events
研究概览
简要总结
The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
详细描述
The purpose of this extension study is to evaluate long-term safety and tolerability of ianalumab administered s.c. monthly or quarterly, compared to monthly placebo, in adolescent and adult participants with anti-nuclear antibody (ANA)-positive systemic lupus erythematosus of moderate-to-severe disease activity, who have completed either CVAY736F12301 (SIRIUS-SLE 1) or CVAY736F12302 (SIRIUS-SLE 2) core studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 100 Years（Child, 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. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants <18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.
- •Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.
- •In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.
排除标准
- •Use of prohibited therapies.
- •Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.
- •Plans for administration of live vaccines during the study period.
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, refusing or unable to use highly effective methods of contraception while on study treatment and for 6 months after stopping of study drug (or longer if required by concomitant medications).
- •United States (and other countries, if locally required): sexually active males, unless they agree to use barrier protection during intercourse with women of child-bearing potential while taking study treatment.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Placebo monthly
Placebo s.c. monthly
干预措施: Placebo (Drug)
Ianalumab monthly
Ianalumab s.c. monthly
干预措施: Ianalumab (Drug)
Ianalumab quarterly
Ianalumab s.c. quarterly
干预措施: Ianalumab (Drug)
结局指标
主要结局
Number of treatment-emergent Adverse events/Serious Adverse events
时间窗: through study completion, up to approximately 91 months
Assessment of long-term safety and tolerability of ianalumab
次要结局
- Proportion of participants who achieved Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response(up to Week 216)
- Change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology (SLICC/ACR) Damage Index(up to Week 216)
- Average daily dose of oral corticosteroids administered(up to Week 216)
- Annualized BILAG moderate or severe flare rate(up to Week 216)