A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults With Systemic Lupus Erythematosus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 58
- 主要终点
- Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).
详细描述
This is an open-label extension study to evaluate long-term safety and tolerability of intravenous (IV) anifrolumab in adult participants with moderately-to-severely active SLE. Participants must have completed the qualifying Phase 2 study and meet this study criteria in order to be eligible.
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 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be willing to use 2 methods of effective contraception
- •Must have venous access
- •Must be willing to forego participation in other clinical trials for SLE.
排除标准
- •Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- •Major surgery within 8 weeks before signing informed consent form (ICF)
- •Elective major surgery planned during the study period
- •Concomitant Medications within the last 12 weeks: Azathioprine > 200 mg/day, Mycophenolate mofetil/mycophenolic acid > 2.0 g/day, oral, subcutaneous, or intramuscular methotrexate > 25 mg/week
- •A live or attenuated vaccine within 4 weeks of signing the ICF
- •Bacillus of Calmette and Guérin (BCG) vaccine within 1 year of ICF
研究组 & 干预措施
Anifrolumab
Participants will receive IV infusion of anifrolumab 1000 milligrams (mg) every 4 weeks (Q4W) from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter will receive 300 mg Q4W for up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
干预措施: Anifrolumab (Biological)
结局指标
主要结局
Number of Participants With Adverse Events Resulting in Discontinuation (DAEs) of Anifrolumab
时间窗: From first dose of study drug (Day 1) through 168 weeks
Number of participants with DAEs are reported.
Number of Particpants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
时间窗: From first dose of study drug (Day 1) through 168 weeks
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event is any AE that resulted in death, life threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.
Number of Participants With Adverse Events of Special Interest (AESIs)
时间窗: From first dose of study drug (Day 1) through 168 weeks
An AESI is scientific and medical concern specific to understanding of the study drug. An AESI may be serious or non-serious. Number of participants with AESIs are reported.
次要结局
- Number of ADA-positive Participants With Decreased Serum Concentration of Anifrolumab(Baseline (Pre-dose on Day 1) up to Week 168)
- Anti-Drug Antibodies (ADA) Titer to Anifrolumab(Baseline (Pre-dose on Day 1) up to Week 168)
- Number of ADA-positive Participants With Decreased Pharmacodynamics Response of Anifrolumab(Baseline (Pre-dose on Day 1) up to Week 168)
- Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer to Anifrolumab(Baseline (Pre-dose on Day 1) up to Week 168)
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Global Score for ADA Positive Participants(Baseline (Pre-dose on Day 1); and Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 160, and 168)
- Number of ADA-positive Participants With TEAEs and TESAEs(Baseline (Pre-dose on Day 1) up to Week 168)