A Randomized, Controlled, Double-blind, Continuation Study Comparing the Long-term Safety and Efficacy of Voclosporin (23.7 mg Twice Daily) With Placebo in Subjects With Lupus Nephritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments.
研究概览
简要总结
The purpose of this study is assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with lupus nephritis (LN).
详细描述
The aim of the Phase 3 continuation study (AURORA 2) is to assess the long-term safety and tolerability of voclosporin, added to the standard of care treatment in LN, for an additional 24 months, following a treatment period of 52 weeks in the AURORA 1 study (AUR-VCS-2016-01). All subjects will continue to receive background therapy of mycophenolate mofetil (MMF) and/or oral corticosteroids starting at the same dose as at the end of the AURORA 1 study. Subjects with LN, who have completed 52 weeks of treatment with study drug in the AURORA 1 study, will be eligible to enter the study. The long-term safety and tolerability of the drug combination will be assessed from its safety profile while demonstrating the continued ability to achieve and maintain long-term renal response.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed 52 weeks of treatment with study drug in the AURORA 1 study. Subjects who had a temporary interruption and successfully restarted study drug during the AURORA 1 study will be allowed with Medical Monitor approval.
- •Written informed consent before any study-specific procedures were performed.
- •In the opinion of the investigator, subject required continued immunosuppressive therapy.
- •Women of childbearing potential must continue to use effective contraception and have a negative urine pregnancy test at Month
- •Subject is willing to continue taking oral mycophenolate mofetil (MMF) for the duration of the study.
排除标准
- •Currently taking or known need for any of the medications or food items listed in Section 7.8, Prohibited Therapy and Concomitant Treatment during the study.
- •Subjects currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
- •A planned kidney transplant within study treatment period.
- •Subjects with any medical condition which, in the Investigator's judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.
- •Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.
- •Vaccines using live organisms, virus or bacterial, while taking the study treatment.
研究组 & 干预措施
Voclosporin
Voclosporin
干预措施: Voclosporin (Drug)
Placebo Oral Capsule
Placebo
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Adverse Events (AE) Profile and Routine Biochemical and Hematological Assessments.
时间窗: Month 12 (AURORA 2 baseline) to Month 36
Number (and percent) of adverse events experienced during the AURORA 2 treatment period. To assess the long-term safety and tolerability of voclosporin compared with placebo for up to an additional 24 months following completion of treatment in the AURORA 1 study in subjects with LN.
次要结局
- Number (and Percent) of Subjects in Renal Response(Months 12 (AURORA 2 Baseline), 18, 24, 30 and 36)
- Renal Flare as Adjudicated by the Clinical Endpoints Committee (CEC).(Month 12 (AURORA 2 baseline) to Month 36)
- Number (and Percent) of Subjects in Partial Renal Response(Months 12 (AURORA 2 baseline), 18, 24, 30 and 36)
- Change From AURORA 1 Baseline (i.e., Month 0) in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI)(Months 18, 24 and 36)
- Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein to Creatinine Ratio (UPCR)(Months 12 (AURORA 2 baseline), 18, 24, 30 and 36)
- Change From AURORA 1 Baseline (i.e., Month 0) in Estimated Glomerular Filtration Rate (eGFR)(Months 12 (AURORA 2 baseline), 18, 24, 30 and 36)
- Change From AURORA 1 Baseline (i.e., Month 0) in Urine Protein(Months 12 (AURORA 2 baseline), 18, 24, 30 and 36)
- Change From AURORA 1 Baseline (i.e., Month 0) in Serum Creatinine (SCr)(Months 12 (AURORA 2 baseline), 18, 24, 30 and 36)