EUCTR2013-002902-29-NL进行中（未招募）1 期
A phase II, multicenter, randomized, double-blind, multiple dose, placebo-controlled, parallel-group study to evaluate the efficacy, pharmacokinetics, and safety of BI 655066, an IL-23 p19 antagonist monoclonal antibody, in patients with moderately to severely active Crohn's disease, who are naïve to, or were previously treated with anti-TNF therapy.
Boehringer Ingelheim bv0 个研究点目标入组 120 人开始时间: 2014年2月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Men or women 18-75 years at the time of consent.
- •- Diagnosis of Crohn's disease at least 3 months prior to screening.
- •- Moderate to severe active Crohn's disease, defined as CDAI >or=220 and Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 119
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •- Complications of Crohn's disease such as strictures, stenoses, short gut syndrome, or any other manifestation that might require surgery.
- •- Presence of ileostomy or colostomy.
- •- Pregnant or nursing women.
- •- Signs or symptoms suggestive of active TB.
- •- History of malignancy.
研究者
相似试验
已完成
不适用
A phase II, multicenter, randomized, double-blind, parallel group study to determine the optimal dose of HL301 after 7 days oral administration in acute bronchitis or acute exacerbations of chronic bronchitis patients.Diseases of th respiratory systemKCT0001239Hanlim Pharmaceutical156
进行中（未招募）
1 期
Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.Crohn's diseaseEUCTR2013-002902-29-GB120
进行中（未招募）
1 期
Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.Crohn's diseaseEUCTR2013-002902-29-IE120
进行中（未招募）
1 期
Efficacy, safety and pharmacokinetics of BI 655066 in patients with active, moderate-to-severe Crohn's disease.Crohn's diseaseEUCTR2013-002902-29-BESCS Boehringer Ingelheim Comm.V120
进行中（未招募）
不适用
A phase II, multicenter, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif New Formulation in Multiple Scleroris Subjects with Active Disease - Phase II Cladribine add-on to Rebif New Formulation in MS subjects with active diseaseMedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosisMULTIPLE SCLEROSISEUCTR2006-003366-33-ITMERCK SERONO INTERNATIONAL SA260