A Phase II, Open-Label Extension Study of Patients Previously Enrolled in Study GA30044 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 160
- 试验地点
- 52
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
This Phase II, multicenter, open-label extension (OLE) study will evaluate the long-term safety and efficacy of GDC-0853 in participants with systemic lupus erythematosus (SLE) who have completed Study GA30044 (NCT02908100) up to 48 weeks.
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
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to comply with the study protocol, in the investigator's judgment
- •Completion of Study GA30044 up to 48 weeks
- •Acceptable safety and tolerability during Study GA30044 as determined by the investigator
排除标准
- •Met protocol-defined treatment-stopping criteria during Study GA30044
- •An adverse event in Study GA30044 that required permanent discontinuation of study drug
- •In the opinion of the investigator, any new, significant, uncontrolled comorbidity or new clinical manifestation (related to SLE or not) that requires medications not allowed in this protocol; or could put the participant at undue risk from a safety perspective
- •Any uncontrolled or clinically significant laboratory abnormality that would affect safety, interpretation of study data, or the participant's participation in the study in the opinion of the investigator in consultation with the Medical Monitor
研究组 & 干预措施
GDC-0853 (200mg) BID
Participants previously enrolled in the parent GA30044 Study, now received GDC-0853 (200mg) orally twice daily (BID).
干预措施: GDC-0853 (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Baseline up until 8 weeks after the last dose of study drug (up to 56 weeks)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
次要结局
- Area Under the Concentration-Time Curve From Time 0 to Time t (AUC0-t,ss) of GDC-0853 at Steady State(Pre-dose (0 hour [hr]) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56))
- Systemic Lupus Erythematosus Responder-4 Index (SRI-4) up to Week 48(Baseline up to Week 48)
- Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)(Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56))
- Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)(Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56))
- Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)(Pre-dose (0 hr) at Weeks 0, 24, 48, at unscheduled or flare or early termination visit (up to Week 56))