An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- Incidence of Treatment Emergent Adverse Events (TEAE)
研究概览
简要总结
The purpose of this study is to assess the long-term safety and tolerability of voclosporin for up to an additional 12 months following completion of treatment in the AUR-VCS-2020-03 study (VOCAL) in adolescent and pediatric subjects with lupus nephritis.
详细描述
This is a 12 month, prospective, multi-center, long-term, open-label extension study of voclosporin in addition to background standard of care with mycophenolate mofetil (MMF) and oral steroids.
Subjects completing participation and treatment with study drug (voclosporin/placebo) of the VOCAL Study (AUR-VCS-2020-03 ; NCT05288855) and meeting all eligibility criteria will receive open-label treatment with voclosporin for approximately 12 months giving a total study treatment duration of 18 months from the start of VOCAL.
All subjects will continue to receive background therapy of MMF and oral corticosteroids starting at the same dose as at completion of the VOCAL study. When clinically indicated, subjects are permitted to be titrated off oral corticosteroids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from parent/guardian before any study-specific procedures are performed, if applicable per local regulations.
- •Age-appropriate assent or informed consent from subject before any study-specific procedures are performed.
- •Subjects who have completed 24 weeks of treatment with study drug (voclosporin/placebo) in the VOCAL study. Subjects who had a temporary interruption and were able to successfully re-start study drug will be allowed to enroll after Medical Monitor approval.
- •In the opinion of the Investigator subject requires continued immunosuppressive therapy.
- •Subject is willing to continue to take oral MMF for the duration of the study.
排除标准
- •Currently taking or known need for any of the following medications during the study:
- •Cholestyramine or other drugs that may interfere with enterohepatic recirculation of MMF
- •Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus)
- •Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin)
- •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 judgement may be associated with increased risk to the subject or may interfere with study assessments or outcomes
研究组 & 干预措施
Open Label
All subjects will receive open label voclosporin initially at the same number of capsules as assigned at Week 24 (End of Study Visit) in AUR-VCS-2020-03 (VOCAL ; NCT05288855). At the Investigator's discretion and after consultation with the Medical Monitor, dose titration up or down in the study will be permitted up to the maximum dose that was studied in AUR-VCS-2020-03.
干预措施: voclosporin (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events (TEAE)
时间窗: Per protocol from VOCAL-EXT Study Start to Study Completion plus a 30-day follow-up period
Incidence (subject counts and event counts) of TEAEs summarized by System Organ Class and Preferred Terms using MedDRA
次要结局
- Renal Response(Per protocol from Study Start to Study Completion plus a 30-day follow-up period)
- Partial Renal Response(Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion))
- Urine Protein Creatinine Ratio (UPCR)(Month 12 (VOCAL Study Completion/VOCAL-EXT Study Start) and Month 18 (VOCAL-EXT Study Completion))