A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 791
- 试验地点
- 133
- 主要终点
- The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
研究概览
简要总结
The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive antinuclear antibodies (ANA) at Screening (Visit 1)
- •Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
- •Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
- •Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
- •On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials
排除标准
- •Subjects who are breastfeeding, pregnant, or plan to become pregnant
- •Subjects with active, severe SLE disease activity which involves the renal system
- •Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
- •Subjects with the evidence of an immunosuppressive state
- •Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
- •History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
- •Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
- •Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
- •Subjects with substance abuse or dependence or other relevant concurrent medical condition
- •Subjects with history of thromboembolic events within 1 year of screening Visit.
- •Subjects with significant hematologic abnormalities
- •Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
- •Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
- •Subject has previously participated in this study or has previously received epratuzumab treatment.
研究组 & 干预措施
Placebo (Weekly infusion)
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
干预措施: Placebo (Drug)
Epratuzumab 600 mg per week
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
干预措施: Epratuzumab (Drug)
Epratuzumab 1200 mg every other week
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
干预措施: Placebo (Drug)
Epratuzumab 1200 mg every other week
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
干预措施: Epratuzumab (Drug)
结局指标
主要结局
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
时间窗: At Week 48
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
次要结局
- The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index(At Week 12)
- The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index(At Week 36)
- The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index(At Week 24)
- Change From Baseline in Daily Corticosteroid Dose at Week 24(At Week 24)
- Change From Baseline in Daily Corticosteroid Dose at Week 48(At Week 48)