EUCTR2013-000263-88-BG进行中（未招募）1 期
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects with Moderately to Severely Active Ulcerative Colitis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
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
- •- Have a clinical diagnosis of ulcerative colitis (UC) at least 3 months prior to screening
- •- Have moderately to severely active UC, defined as a baseline (Week 0) Mayo score of 6 to 12 ; including an endoscopy subscore greater than or equal to 2 as determined by a central read of the video endoscopy
- •- Current treatment with oral corticosteroids or have a history of failure to respond to, or tolerate, at least 1 of the following therapies oral corticosteroids (including budesonide), 6-mercaptopurine (6-MP), azathioprine (AZA), or anti-tumor necrosis factor therapy or be corticosteroid dependent (ie, an inability to successfully taper corticosteroids without a return of the symptoms of UC
- •- Must discontinue 6-MP/AZA for at least 1 week before the first dose of study medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 209
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •- At imminent risk for colectomy
- •- Have ulcerative colitis limited to the rectum only or to less than 20 centimeter of the colon
- •- Presence of a stoma
- •- Presence or history of a fistula
- •- History or current diagnosis of active or latent tuberculosis, human immunodeficiency virus, hepatitis C virus or hepatitis B virus infection
- •- Have had more than 1 herpes zoster infection or have had any diagnosis disseminated herpes zoster
- •- Previous treatment with a janus kinase inhibitor (eg, tofacitinib)
研究者
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