NCT01461317已完成2 期
A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 40
- 主要终点
- Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
研究概览
简要总结
This study is an open-label extension (OLE) trial to evaluate the safety and tolerability of etrolizumab in participants with moderate to severe ulcerative colitis (UC) who were enrolled in the Phase II Study ABS4986g (NCT01336465) and meet the eligibility criteria for entry in the OLE study.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants (placebo or active) who were previously enrolled in the Phase II study (ABS4986g) and fulfill any of the following criteria:
- •Participants who have not obtained a clinical response in the Phase II study (ABS4986g) by Week 10 (the end of the Phase II treatment phase) may enter this OLE trial at any time after Week 10 and up to and including Week 28
- •Participants who have a clinical response in the Phase II study (ABS4986g) at Week 10 but have had a flare of UC between Week 10 and Week 28
- •Males and females with reproductive potential must be willing to use a highly effective method of contraception, vaginal ring, intrauterine device, physical barrier, or vasectomized partner) from study start to a minimum of 4 months (approximately 5 half-lives)
- •Concomitant immunosuppressive therapy must be tapered within 6 weeks after enrollment in this OLE study
- •Participants must have tapered completely off oral corticosteroids within 24 weeks of enrollment to this OLE study
排除标准
- •Participants who did not complete through Week 10 of the Phase II study (ABS4986g)
- •Pregnancy or lactation
- •Any new malignancy within the past 6 months
- •Any new (since enrolling in the Phase II study [ABS4986g]), significant, uncontrolled, co- morbidity, such as neurological, cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal (GI) disorders
- •Any new clinically significant signs or symptoms of infection as judged by the investigator
- •Any abnormal laboratory values recorded at the last visit completed in the Phase II study (ABS4986g)
研究组 & 干预措施
Etrolizumab
Experimental
Etrolizumab 100 milligrams (mg) subcutaneous (SC) administration every 4 weeks during the treatment period of up to 240 weeks.
干预措施: Etrolizumab (Drug)
结局指标
主要结局
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab
时间窗: Baseline up to approximately Week 246 (assessed at predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to Week 252, 12 weeks after last dose [up to approximately Week 246])
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: Baseline up to approximately Week 246
次要结局
- Serum Concentrations of Etrolizumab(Predose (Hour 0) at baseline, Weeks 4, 8, 12, and every 12 weeks thereafter up to approximately Week 246; 12 weeks after last dose (up to approximately Week 246))
研究者
研究点 (40)
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