NCT01635621撤回2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Olokizumab Administered Subcutaneously to Subjects With Moderate to Severe Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Percentage of subjects with clinical response or remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 8
研究概览
简要总结
The primary purpose of this multi-centre, double blind-study is to evaluate the clinical response of patients with moderate to severe Cohn's Disease (CD) following treatment with different doses and dose regimens of Olokizumab, relative to placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female, 18 to 65 years of age at Screening
- •Diagnosis of CD (colonic localization) confirmed (at least 12 weeks prior to Screening) by either radiological or endoscopic evidence and/or histological examination
- •Colonoscopy performed prior to first study medication administration (Week 0) with evidence of active CD and presence of ulceration but with no clinical suspicion of dysplasia or malignancy (colonoscopy to be performed after informed consent has been received, and all other Screening assessments have been completed)
- •Moderately to severely active CD (CDAI score: 220 to 450, inclusive) at Baseline
- •Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (either oral/ parenteral /implantable hormonal contraceptives, intrauterine device or barrier and spermicide)
排除标准
- •Subject has a diagnosis of Ulcerative Colitis or Indeterminant Colitis as determined by the investigator
- •Subject has obstructive strictures with clinical evidence of partial or complete obstruction
- •Subject has an active fistula (fistula secreting spontaneously or by gentle pressure)
- •Subject has a history of diverticulitis or symptomatic diverticulosis
- •Subject has any prior exposure to anti-IL-6 agents (eg, Tocilizumab)
- •Female subjects who are breastfeeding, pregnant, or plan to become pregnant during the study or within 24 weeks following the last dose of the study drug
- •Subject has a high risk of infection (eg, subjects with leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections, and subjects who are permanently bedridden or wheelchair bound)
- •Subject has a concurrent malignancy or a history of malignancy. Subjects who have been successfully treated and who have remained malignancy-free for at least 5 years prior to Screening may be included
研究组 & 干预措施
OKZ 120 mg
Experimental
干预措施: Olokizumab (OKZ) (Drug)
OKZ 240 mg
Experimental
干预措施: Olokizumab (OKZ) (Drug)
OKZ 120 mg with 480 mg loading dose at Week 0
Experimental
干预措施: Olokizumab (OKZ) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects with clinical response or remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 8
时间窗: Week 8
次要结局
- Percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 16(Week 16)
- Percentage of subjects with clinical response as measured by the Crohn's Disease Activity Index (CDAI) at Week 16(Week 16)
- Percentage of subjects with clinical remission as measured by the Crohn's Disease Activity Index (CDAI) at Week 16(Week 16)
- Change from Baseline in the Crohn's Disease Activity Index (CDAI) to Week 16(From Baseline to Week 16)
- Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) total score at Week 16(From Baseline to Week 16)
- Percentage of subjects with Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 16(Week 16)
研究者
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