CTIS2023-505929-14-00招募中1 期
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) - VAY736F12301E1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 588
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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.
研究者
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